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Background: Growing evidence shows that many parents begin the decision-making process about infant vaccination during pregnancy and these decisions - once established - may be resistant to change. Despite this, many interventions targeting vaccination are focused on communicating with parents after their baby is born. This suggests that the prenatal period may constitute a missed opportunity for communicating with expectant parents about infant vaccination.Methods: Using a longitudinal qualitative design, we conducted two interviews (prepartum and postpartum) with women (n = 19) to explore the optimal timing of vaccination information. The data were analyzed thematically, and examined across all sets of pre- and post-partum interviews as well as within each individual participant to draw out salient themes.Results: Most participants formed their intentions to vaccinate before the baby was born and indicated that they would welcome information about vaccination from their maternity care providers. However, few individuals recalled their maternity care providers initiating vaccination-related conversations with them.Conclusion: The prenatal period is an important time to begin conversations with expectant parents about vaccinating their infants, particularly if these conversations are initiated by trusted maternity care providers. More information is needed on how maternity care providers can be better supported to have these conversations with their patients. [ABSTRACT FROM AUTHOR]

Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination and influenza vaccination are recommended during pregnancy primarily to prevent influenza and pertussis in mothers and their infants. This study examines associations between prenatal Tdap vaccination and influenza vaccination of mothers and hepatitis B vaccination of their infants. A retrospective cohort study was conducted using data from electronic medical records from 15,468 deliveries to 14,925 mothers occurring April 2, 2014-December 3, 2016 at a university hospital in Texas. Hepatitis B vaccine receipt in the first 3 days of life was dichotomized. Margins post-estimation commands in Stata SE 15.1 were used to obtain predicted probabilities and risk differences after estimating odds ratios in logistic regression with robust variance estimates. Adjusted models included maternal age, race/ethnicity, Medicaid use, year of delivery, parity, and gravidity. Infants of mothers who received prenatal influenza vaccination in the 2014-2015 and 2015-2016 influenza seasons were more likely than those of mothers who did not to receive a hepatitis B vaccine in their first 3 days of life (adjusted risk difference (RD) 2.8%, 95% confidence interval (CI) 1.5-4.1% and RD 2.2%, 95% CI 0.9-3.5%, respectively). Hepatitis B vaccination was also higher among infants of Tdap-eligible mothers who received prenatal Tdap vaccination during pregnancy compared to those of mothers who did not (adjusted RD 9.1%, 95% CI 7.6-10.5%). Overall, prenatal vaccination was significantly associated with uptake of infant hepatitis B vaccine. [ABSTRACT FROM AUTHOR]

Pain is an unpleasant sensation that can range from mild, localized discomfort to agony. It is too difficult to face pain of vaccinations in children.Helfer skin tapping technique is resulting to minimize the level of pain during intramuscular injections among children. Objective- Primary objective behind this literature review is to find out effectiveness of helfer skin tap technique in reduction of level of pain among children. Method- A systematic literature review was conducted. The literature includes last 8years’ data. The literature reviewed was obtained through different database includes CINHAL (Cumulative index TO Nursing & Allied Health Literature), MEDLINE (Medical Literature Analysis & Retrieval System Online), PubMed, Science Direct, SpringerLink, ProQuest & Google scholar. Result—Pain level of experimental group is less than control group. Helfer skin tap technique is effective to reducing the level of pain among infants who are undergone with pentavalent vaccination. Conclusion—Helfer skin tap technique is helpful in minimizing the level of pain during vaccination among infants. All the nurses can perform Helfer skin tap technique in routine practices for reducing pain intensity. [ABSTRACT FROM AUTHOR]

Background Delivering vaccination services during the second year of life (2YL) 1 Abbreviations: 2YL, denotes Second Year of Life or 2nd Year of Life. 1 provides countries with an opportunity to achieve greater coverage, to provide booster doses and vaccines missed during the first year of life, as well as contribute towards disease control and elimination goals. Methods Using data from demographic health surveys (DHSs) conducted during 2010 to 2016, this paper explores the proportion of missed opportunities for vaccinations generally provided during routine immunization among children in their 2YL. Results DHS data in 46 countries surveyed 478,737 children, from which 169,259 children were 12–23 months old and had vaccination/health cards viewed by surveyors. From this group, 69,489 children aged 12–23 months had contact with health services in their 2YL. Three scenarios for a missed opportunity for vaccinations were analysed: (1) a child received one vaccine in the immunization schedule and was eligible for another vaccine, but did not receive any further vaccination, (2) a child received a vitamin A supplementation (VAS) and was due for a vaccine, but did not receive vaccines that were due, and (3) a child was taken to a health facility for a sick visit and was due (and eligible) for a vaccine, but did not receive the vaccine. A total of 16,409 (24%) children had one or more missed opportunities for vaccinations. Conclusion This analysis highlights the magnitude of the problem of missed opportunities in the 2YL. The global community needs to provide better streamlined guidance, policies and strategies to promote vaccination screenings at well-child and sick child visits in the 2YL. Where they do not exist, well-child visits in the 2YL should be established and strengthened. [ABSTRACT FROM AUTHOR]

Introduction Vaccination in pregnancy is an effective method to protect against disease for the pregnant woman, foetus and new born infant. In England, it is recommended that pregnant women are vaccinated against pertussis and influenza. Improvement in the uptake of both pertussis and influenza vaccination among pregnant women is needed to prevent morbidity and mortality for both the pregnant women and unborn child. Aim To identify effective strategies in increasing the uptake of vaccination in pregnancy in high-income countries and to make recommendations for England. Methods A systematic review of peer reviewed literature was conducted using a keyword search strategy applied across six databases (Medline, Embase, PsychInfo, PubMed, CINAHL and Web of Science). Articles were screened against an inclusion and exclusion criteria and papers included within the review were quality assessed. Results and conclusions Twenty-two articles were included in the review. The majority of the papers included were conducted in the USA and looked at strategies to increase influenza vaccination in pregnancy. There is limited high quality evidence for strategies in high-income countries to increase coverage of pertussis and influenza vaccination in pregnancy. A number of strategies have been found to be effective; reminders about vaccination on antenatal healthcare records, midwives providing vaccination, and education and information provision for healthcare staff and patients. Future interventions to increase vaccination in pregnancy should be evaluated to ensure efficacy and to contribute to the evidence base. [ABSTRACT FROM AUTHOR]

Background Hepatitis B virus (HBV) vaccination has decreased the prevalence of chronic HBV infections and their sequelae. However, whether vaccination at birth provides lifelong protection is unclear. Objective To assess long-term immunity following neonatal HBV immunization in a large population-based cohort. Methods Using the database of a 2 million member sick fund in Israel, we identified all subjects born after introduction of universal HBV vaccination in Israel (January 1992 through December 2014), that were tested for hepatitis B surface antibody (anti-HBs Ab's). Years since vaccination were categorized into 5-year groups and linear trends in the seroprevalence of HBV immunity were calculated. Anamnestic response and presence of Hepatitis B surface antigen (HBs Ag) were assessed. Results Included were 20,634 tested individuals. Mean (±SD) age at testing was 14.8 (±5.4) years. Mean anti-HBs Ab levels declined with time to 16.39 mIU/ml in the 15–20 year group (P < 0.001). The proportion of negative results increased gradually (P < 0.001) to 66.7% after 15 years. Anamnestic response assessment showed that 604 of 644 seronegative subjects (93.8%, 95% CI: 91.6–95.5%) became seropositive after a booster dose. HBs Ag was identified in 91 of the 20,634 (4.4 per 1000 study participants). Conclusions Following vaccination, anti-HB's Ab's progressively decline, with only a third of the population retaining protective levels after 15 years. In adolescence, anamnestic response shows that nearly all revaccinated adolescents exhibit immunity. A low rate of Hepatitis B infection was demonstrated despite vaccination of nearly all newborns. [ABSTRACT FROM AUTHOR]

Background During a pertussis epidemic in 2009, the Department of Health, Victoria, Australia, implemented a cocoon program offering parents of new babies a funded-dose of pertussis-containing vaccine. We assessed vaccine effectiveness (VE) of the program in reducing pertussis infection in infants. Methods Using a matched case-control design, infants aged <12 months that were notified with pertussis between 1 January 2010 and 31 December 2011, and born during the time that the cocoon program was in place, were identified. Controls were matched by area of residence and date of birth. Telephone interviews we conducted to ascertain parents’ vaccination status, and if vaccinated, timing of vaccination receipt relative to the birth of their baby. Odds ratios (ORs) were calculated for the association between vaccination and pertussis infection, with VE calculated as (1 – OR) × 100%. Results The study recruited 215 cases and 240 controls (response rates 67% and 25% of eligible participants, respectively). Vaccination of both parents after delivery of the infant and ≥28 days prior to illness onset reduced pertussis infection by 77% (Vaccine Effectiveness [VE] = 77% (confidence interval [95% CI], 18–93%). After adjusting for maternal education, presence of a sibling within the household, and the infants’ primary course vaccination status, the adjusted VE was 64% (95% CI, −58–92%). Conclusions Although not reaching statistical significance, our results demonstrated that cocoon immunisation – where both parents are vaccinated in the post-partum period – may offer some protection again infant pertussis infection. Cocoon immunisation could be considered in circumstances where antenatal vaccination of the mother has not occurred. [ABSTRACT FROM AUTHOR]

Background Infants are at the highest risk of severe complications – including death – as a result of pertussis infection. Controlling pertussis in this group has been challenging, particularly in those too young to be vaccinated. Following revised national recommendations in March 2015, the state of New South Wales, Australia, introduced a funded maternal vaccination campaign at 28 – 32 weeks of gestation using a 3-component tetanus-diphtheria-acellular pertussis vaccine (dTpa; Boostrix, GSK). This study aimed to assess the effectiveness of maternal vaccination and add to the growing body of evidence for this strategy. Methods A 1:1 matched case-control study was conducted between 16 August 2015 and 17 August 2016. Cases were laboratory or doctor notified, laboratory confirmed (nucleic acid testing or culture) and aged <6 months at onset. Each control infant was randomly selected from public hospital births in the same geographical area in the period up to 3 days before and after the case’s birthdate. Odds ratios (OR) were calculated using conditional logistic regression. Vaccine effectiveness (VE) was calculated as 1 – OR. Findings In total, 117 cases and 117 controls were recruited. The overall VE estimate was non-significantly protective for infants <6 months old (VE 39%, 95% CI −12 to 66%). Higher VE was observed for infants <3 months old (VE 69%, 95% CI 13–89%) and against hospitalisation (VE 94%, 95% CI 59–99%). Interpretation Maternal pertussis vaccination with a 3-component acellular vaccine was found to be highly effective at preventing severe disease in infants, but was less effective at preventing disease which did not require hospitalisation. The overall VE reported in this study was lower than in prior studies and suggests that maternal vaccination, while an effective strategy at preventing severe pertussis, is less effective at protecting against infection or mild disease. [ABSTRACT FROM AUTHOR]

Objective To identify a potential nadir of the impact of pneumococcal conjugate vaccination (PCV) in infancy on invasive pneumococcal diseases (IPD) in children under 16 in Germany. Methods Active surveillance on IPD based on two independent data sources with capture-recapture correction for underreporting. Annual incidence rates by age group, serotypes, site of infection, and relative incidence reduction compared to pre-vaccination period (1997–2001) at nadir and for the most recent season are reported. We calculated vaccine coverage at the age of 24 months using health insurance claims data. Results 96–97% of children had received at least two doses of PCV since 2009. The maximum impact on overall IPD incidence was achieved in 2012/13 (−48% [95% CI: −55%; −39%]) with a rebound to −26% [95% CI: −36%; −16%] in 2015/16. Non-PCV13 serotypes accounted for 84.1% of the IPD cases in 2015/16. The most frequent non-PCV serotypes in IPD in 2014/15 and 2015/16 were 10A, 24F, 15C, 12F, 38, 22F, 23B, and 15B. The impact at nadir was highest in children 0–1 years of age both in meningitis and non-meningitis cases, whereas the impact for other age groups was higher for meningitis cases. The rebound mainly pertained to non-meningitis cases. Conclusion The maximum impact of pneumococcal conjugate vaccination has been attained and signs of a rebound are apparent. Sustained surveillance for IPD in children is warranted to assess whether these trends will continue. There may be a need for vaccines using antigens common to all serotypes. [ABSTRACT FROM AUTHOR]

Background If immune responses to vaccination differ between males and females, sex-specific vaccination schedules may be indicated. We systematically reanalysed childhood vaccination studies conducted in The Netherlands for sex-differences in IgG-responses. To assess the impact of potential sex-differences in IgG-responses, we explored sex-differences in vaccine failure/effectiveness and reactogenicity. Methods Six studies with IgG-measurements for 1577 children following infant pneumococcal (PCV7/PCV10/PCV13) and/or DTaP-IPV-Hib(-HepB) vaccinations, or the pre-school DTaP-IPV booster were included. We performed one-stage individual participant data meta-analyses per time-point of the effect of sex on IgG levels against pneumococcal serotypes, diphtheria toxoid, tetanus toxoid, pertussis Ptx/FHA/Prn and Hib-PRP using linear mixed models. Using existing study data, we compared reactogenicity after PCV7/PCV10 and DTaP-IPV-Hib(-HepB) vaccination in girls and boys. Vaccine failure/effectiveness was compared between girls and boys for invasive pneumococcal disease (IPD), invasive Hib disease and pertussis using notification data. Results For pneumococcal vaccination, the geometric mean concentration ratio of IgG levels in girls versus boys pooled across serotypes was 1.15 (95%CI 0.91–1.45) 1 month following the primary series, 1.16 (1.02–1.32) at age 8 months, 1.12 (1.02–1.23) pre-booster (age 11 months) and 0.99 (0.89–1.10) post-booster (age 12 months). Diphtheria toxoid, tetanus toxoid, pertussis Ptx/FHA/Prn and Hib-PRP IgG levels did not differ between girls and boys, except for Hib post-booster (1.24; 95%CI 1.01–1.52) and tetanus before pre-school booster (0.71; 0.53–0.95). We found no difference between boys and girls in reactogenicity at age 4 or 11 months or in vaccine failure/effectiveness for IPD, invasive Hib disease or pertussis. Conclusion For most vaccine antigens investigated, there were no consistent differences in vaccine-induced IgG levels. Vaccine-induced pneumococcal IgG levels were slightly higher in girls, but only between the primary series and the 11-month booster. These results, along with similar reactogenicity and vaccine failure/effectiveness, support the uniform infant vaccination schedule in the Dutch national immunisation programme. [ABSTRACT FROM AUTHOR]

Several studies have shown increased in vitro cytokine responses to non-related pathogens after Bacillus Calmette-Guérin (BCG) vaccination. A total of 158 infants (80 BCG administered within 7 days of birth; 78 controls) were bled 4 days post-randomization, and at age 3 and 13 months. Geometric mean concentrations of IL-1β, TNF-α, IL-6 (24 h stimulation) and IFN-γ, IL-10, IL-17, IL-22 (96 h stimulation) in response to in vitro stimulation with RPMI, LPS, PHA, Escherichia coli, Streptococcus pneumoniae, Candida albicans and BCG were compared among BCG vaccinated children and controls. BCG vaccination did not affect in vitro cytokine production, except IFN-γ and IL-22 response to BCG. Stratifying for 'age at randomization' we found a potentiating effect of BCG on cytokine production (TNF-α, IL-6, IL-10) in the 4 days post randomization stimulations, among children who were vaccinated at age 2-7 days versus age 0-1 days. BCG vaccination did not potentiate cytokine production to non-BCG antigens. At 4 days post randomization, BCG was associated with higher cytokine production in the later randomized children. [ABSTRACT FROM AUTHOR]

Background: Infants rely on their parents' sensitive and contingent soothing to support their regulation from pain-related distress. However, despite being of potentially equal or greater import, there has been little focus on how to measure distress-promoting parent behaviors. Aims: The goal of this article was to develop and validate a measure of distress-promoting parent behaviors for acute painful procedures (e.g., vaccinations) that could be used by researchers and clinicians. Methods: Following initial generation of measure items, focused group discussions were held with vaccinating clinicians to understand the measure's face, content, and ecological validity. Archival video footage (n = 537 videos of infant-caregiver dyads during vaccination) was then coded using the measure of distress-promoting behaviors for 3 minutes post vaccine injection. Validity and reliability were examined using correlational analyses. Construct validity was assessed by convergent relationships with infant pain-related distress and divergent relationships were assessed with parent sensitivity and soothing-promoting behaviors. Results: The measure demonstrated both moderate to excellent interrater and test-retest reliability and convergent and divergent validity (absolute magnitude of r's = 0.30 to 0.46). Conclusions: By demonstrating strong reliability and validity, this measure represents a promising new way to understand how caregivers interact with infants during painful procedures. Through focusing on distress promotion and using a format that may be coded both from video or in vivo, it is a feasible way to operationalize the impact of the caregiver on the infant's pain experience in both research and clinical settings. [ABSTRACT FROM AUTHOR]

Perfluorinated alkylate substances (PFASs) are highly persistent and may cause immunotoxic effects. PFAS-associated attenuated antibody responses to childhood vaccines may be affected by PFAS exposures during infancy, where breastfeeding adds to PFAS exposures. Of 490 members of a Faroese birth cohort, 275 and 349 participated in clinical examinations and provided blood samples at ages 18 months and 5 years. PFAS concentrations were measured at birth and at the clinical examinations. Using information on duration of breastfeeding, serum-PFAS concentration profiles during infancy were estimated. As outcomes, serum concentrations of antibodies against tetanus and diphtheria vaccines were determined at age 5. Data from a previous cohort born eight years earlier were available for pooled analyses. Pre-natal exposure showed inverse associations with the antibody concentrations five years later, with decreases by up to about 20% for each two-fold higher exposure, while associations for serum concentrations at ages 18 months and 5 years were weaker. Modeling of serum-PFAS concentration showed levels for age 18 months that were similar to those measured. Concentrations estimated for ages 3 and 6 months showed the strongest inverse associations with antibody concentrations at age 5 years, particularly for tetanus. Joint analyses showed statistically significant decreases in tetanus antibody concentrations by 19–29% at age 5 for each doubling of the PFAS exposure in early infancy. These findings support the notion that the developing adaptive immune system is particularly vulnerable to immunotoxicity during infancy. This vulnerability appears to be the greatest during the first 6 months after birth, where PFAS exposures are affected by breast-feeding. [ABSTRACT FROM PUBLISHER]

Background In Korea, measles occurs mainly in infants <12 months of age, who are unvaccinated. In addition, vaccine populations, including adolescents and young adults, can become infected though importation. Thus, the question arises whether the current level of herd immunity in Korea is now insufficient for protecting against measles infection. Methods Age-specific measles seroprevalence was evaluated by performing enzyme immunoassays and plaque reduction-neutralization tests on 3050 subjects aged 0–50 years (birth cohort 1964–2014) and 480 subjects aged 2–30 years (birth cohort 1984–2012). Results The overall seropositivity and measles antibody concentrations were 71.5% and 1366 mIU/mL, respectively. Progressive decline in antibody levels and seropositivity were observed over time after vaccination in infants, adolescents, and young adults. The accumulation of potentially susceptible individuals in the population was confirmed by comparing data from 2010 and 2014 seroprevalence surveys. The statistical correlation between measles incidence and measles seronegativity was determined. Conclusions Waning levels of measles antibodies with increasing time post-vaccination suggests that measles susceptibility is potentially increasing in Korea. This trend may be related to limitations of vaccine-induced immunity in the absence of natural boosting by the wild virus, compared to naturally acquired immunity triggered by measles infection. This study provides an important view into the current measles herd immunity in Korea. [ABSTRACT FROM AUTHOR]

Objectives We undertook a national survey of parental attitudes to childhood vaccinations and compared results with those in earlier comparable surveys covering a 10 year period. Methods We randomly selected 275 nationally representative sampling locations in England. Interviewers identified eligible primary care givers (referred to as parents) of children aged from 2 months to <5 years and conducted home-based interviews between January and April 2015. We aimed to recruit 1000 parents of children aged 0–2 years and 1000 of children aged 3–4 years. The questionnaire covered all aspects of the immunisation process, vaccines administered in pregnancy and from infancy to pre-school with a maximum of 86 mixed questions. Results Interviews were completed with 1792 parents of whom 1130 had children aged 0–2 years and 999 had children aged 3–4 years; 337 had children of both ages. The findings showed that confidence in and acceptance of the vaccination programme was high. Only 2% of parents reported refusing vaccination whilst 90% reported vaccinating their children automatically when due. Almost all parents (97%) had access to the internet and 34% consulted web-based resources for information on vaccination. Parents who used chat rooms or discussion forums for this purpose were significantly more likely to say they had seen something that would make them doubt having their child(ren) immunised (31% compared to 8% amongst all parents). Health professionals and the NHS were seen as the most trusted source of advice on immunisation (90% agreed/strongly agreed with each). Very few parents did not trust these sources (4% and 3% disagreed, respectively). Conclusions Health professionals remain extremely important in communicating information about vaccination and are highly trusted by parents; a trust that has increased in recent years. Despite most parents seeking information on the Internet, trust in and advice from health care professionals appeared to be key factors influencing parental decisions. [ABSTRACT FROM AUTHOR]

Background Conserved pneumococcal proteins are potential candidates for inclusion in vaccines against pneumococcal diseases. In the first part of a two-part study, an investigational vaccine (PHiD-CV/dPly/PhtD-30) containing 10 pneumococcal serotype-specific polysaccharide conjugates (10VT) combined with pneumolysin toxoid and pneumococcal histidine triad protein D (30 μg each) was well tolerated by Gambian children. Part two, presented here, assessed the efficacy of two PHiD-CV/dPly/PhtD formulations against pneumococcal nasopharyngeal carriage (NPC) prevalence in infants. Methods In this phase 2, randomized, controlled, observer-blind trial, healthy infants aged 8–10 weeks, recruited from a peri-urban health center, were randomized (1:1:1:1:1:1) into six groups. Four groups received PHiD-CV/dPly/PhtD (10 or 30 μg of each protein), PHiD-CV, or 13-valent pneumococcal conjugate vaccine at ages 2–3–4 months (3 + 0 infant schedule) and two groups PHiD-CV/dPly/PhtD-30 or PHiD-CV at 2–4–9 months (2 + 1 infant schedule). The primary objective was impact on non-10VT NPC at ages 5–9–12 months. Secondary objectives included confirmatory analysis of protein dose superiority and safety/reactogenicity. Impact on pneumococcal NPC acquisition, bacterial load, and ply and phtD gene sequencing were explored. Results 1200 infants were enrolled between June 2011 and May 2012. Prevalences of pneumococcal (60–67%) and non-10VT (55–61%) NPC were high at baseline. Across all post-vaccination time points, efficacy of PHiD-CV/dPly/PhtD-10 and PHiD-CV/dPly/PhtD-30 against non-10VT NPC (3 + 0 schedule) was 1.1% (95% CI −21.5, 19.5) and 2.1% (−20.3, 20.3), respectively; efficacy of PHiD-CV/dPly/PhtD-30 (2 + 1 schedule) was 0.5% (−22.1, 18.9) versus PHiD-CV. No differences were observed in pneumococcal NPC acquisition, clearance, or bacterial load. Both protein-based vaccines elicited immune responses to pneumococcal proteins. Conclusions In this high carriage prevalence setting, inclusion of pneumococcal proteins in the PHiD-CV/dPly/PhtD investigational vaccine had no impact on pneumococcal NPC in infants, regardless of protein dose or schedule. Future evaluations will assess its impact against pneumococcal disease endpoints. Funding: PATH, GlaxoSmithKline Biologicals SA. ClinicalTrials.gov identifier NCT01262872 . [ABSTRACT FROM AUTHOR]

Qualitative study by semi-structured interviews, conducted between October 2013 and March 2014 on the Rhône-Alpes region (France), with 24 GPs. Learning is missing in GPs' initial academic training. Contraindications and consent from the patient or its parents are expected. There are flaws in pre-vaccine checks because of the early delivery by the pharmacist. Overall, the 2013 recommendations are respected, hands hygiene by washing or the use of gloves are seen as unnecessary. Concerning the "reconstituted" vaccines, disinfection of the stopper of the lyophilisate is mentioned only once in two. Whatever the age and corpulence of the patient, reconstitution is mostly done with the 23G needle; the 25G needle, of smaller diameter, is used for injection. Forgetting the reconstitution is the most common mistake. The purge is carried out. Local disinfection is constant, the injection site widely respected except by a minority. Disposal of waste is properly done. Traceability is dual except for influenza vaccines. The adverse effect information is usually modest and made on demand. Postvaccination care rarely exceeds a few minutes. The analysis of the immunization practices of GPs shows the existence of choices, incidents, deliberate or involuntary errors or fault, consciously or unconsciously made. This process could be improved; a checklist could be used for the benefit of patients and vaccinators. [ABSTRACT FROM AUTHOR]

Background: In 2009, the European Medicines Agency granted approval for two higher-valent pneumococcal conjugate vaccines. This study aims to evaluate the cost-effectiveness of universal infant (<2 years old) vaccination with a 13-valent pneumococcal conjugate vaccine (PCV13) in comparison with a 10-valent pneumococcal conjugate vaccine (PCV10) for the prevention of pneumococcal disease in Germany.Methods: A population-based Markov model was developed to estimate the impact of PCV13 and PCV10 on invasive pneumococcal disease (IPD), non-invasive pneumonia (PNE), and acute otitis media (AOM) over a time horizon of 50 years. The model included the effects of the historical vaccination scheme in infants as well as indirect herd effects and replacement disease. We used German epidemiological data to calculate episodes of IPD, PNE, and AOM, as well as direct and indirect effects of the vaccination. Parameter uncertainty was tested in univariate and probabilistic sensitivity analyses.Results: In the base-case analysis, the ICER of PCV13 versus PCV10 infant vaccination was EUR 9826 per quality-adjusted life-year (QALY) gained or EUR 5490 per life-year (LY) gained from the societal perspective and EUR 3368 per QALY gained or EUR 1882 per LY gained from the perspective of the German statutory health insurance. The results were particularly sensitive to the magnitude of indirect effects of both vaccines.Conclusions: Universal infant vaccination with PCV13 is likely to be a cost-effective intervention compared with PCV10 within the German health care system, if additional net indirect effects of PCV13 vaccination are significant. [ABSTRACT FROM AUTHOR]

Objective: In Slovakia, thanks to a highly effective vaccination programme, no domestic cases of measles have been reported since 1999. However, there are several outbreaks of measles currently hitting some countries in Europe. Difficulties in reaching the goal of measles elimination make it necessary to monitor the status of the population susceptibility to prevent similar outbreaks in the future. We hypothesize that immunity wanes overtime, which can substantially impact the population susceptibility. This work introduces a model that estimates a proportion of individuals susceptible to measles in the Slovak population in 2015.Methods: Our analysis is based on an age-cohort model that incorporates waning immunity, vaccination schedule and changes in demographic structure. The inputs of the model are data on the vaccination coverage, last seroprevalence survey in 2002 and age structure of the population.Results: In a short-term horizon, waning immunity does not affect the estimated proportion of the susceptible population. However, in a long-term horizon, the antibody titers can fall below the level of protection, which would result in a substantial transfer of initially immune individuals to the compartment of the susceptible ones. Incorporating of waning immunity in the cohort model has indicated that the most susceptible cohorts are not-vaccinated youngest children and cohorts born between 1969 and 1986.Conclusions: Applying the model to the current situation shows that people aged 30-45 years and unvaccinated infants represent the most susceptible groups. Model partially replaces missing seroprevalence survey, but, because the parameters of model and phenomenon of waning immunity are not exactly known, we suggest reintroducing the regular national serosurveys in order to empirically determine the level of susceptibility for measles in Slovakia. [ABSTRACT FROM AUTHOR]

Objectives: The knowledge about outcomes of infant vaccination against HBV infections using the DPT-HepB-Hib vaccine in Ghana is limited. This study therefore investigated the levels of immunity to HBV among children who received the DPT-HepB-Hib vaccine and HBsAg carriage in non-responders. Correlates for non-response or poor response were also investigated. Methods: Cross-sectional study. A major paediatric hospital in Accra. Four hundred and twenty four children between the ages of 5 to 32 months who had completed the full vaccination schedule for the DPT-HepB-Hib vaccine. Results: Of the 424 children, 358 (84.4%) developed anti-HBs while 340 (80.2%) developed =10 mIU/ml anti-HBs (sero-protection) and 3 had HBsAg. A binary logistic regression analysis showed that younger children were associated with sero-conversion (p=.022) and sero-protection (p=.021). For anti-HBs titres =100 mIU/ml age was a weaker but significant contributor (p=.041), as compared to the number of vaccines from different manufacturers the child used (p=.028). The mean age of those who used a single type of vaccine was higher (14.75 ± 6.056 months; n=268) than those who used vaccines from two or more manufacturers (11.96 ± 4.645 months; n=156), p= <.001 (CI: -3.897 - 1.688), an indication that efforts to procure vaccine from same source when it was initially introduced are waning. Conclusions: There is still a residual possibility of infection with HBV in spite of infant vaccination. In the light of possible loss of anamnestic response over time, there is the need to consider a birth dose for HBV vaccination for all neonates or booster dose for infants who may not have received the vaccine at birth. Using vaccines from a single manufacturer is recommended. [ABSTRACT FROM AUTHOR]

Background. Few data exist describing pertussis epidemiology among infants and children in low- and middle-income countries to guide preventive strategies. Methods. Children 1–59 months of age hospitalized with World Health Organization–defined severe or very severe pneumonia in 7 African and Asian countries and similarly aged community controls were enrolled in the Pneumonia Etiology Research for Child Health study. They underwent a standardized clinical evaluation and provided nasopharyngeal and oropharyngeal swabs and induced sputum (cases only) for Bordetella pertussis polymerase chain reaction. Risk factors and pertussis-associated clinical findings were identified. Results. Bordetella pertussis was detected in 53 of 4200 (1.3%) cases and 11 of 5196 (0.2%) controls. In the age stratum 1–5 months, 40 (2.3% of 1721) cases were positive, all from African sites, as were 8 (0.5% of 1617) controls. Pertussis-positive African cases 1–5 months old, compared to controls, were more often human immunodeficiency virus (HIV) uninfected-exposed (adjusted odds ratio [aOR], 2.2), unvaccinated (aOR, 3.7), underweight (aOR, 6.3), and too young to be immunized (aOR, 16.1) (all P ≤ .05). Compared with pertussis negative African cases in this age group, pertussis-positive cases were younger, more likely to vomit (aOR, 2.6), to cough ≥14 days (aOR, 6.3), to have leukocyte counts >20 000 cells/μL (aOR, 4.6), and to have lymphocyte counts >10 000 cells/μL (aOR, 7.2) (all P ≤ .05). The case fatality ratio of pertussis-infected pneumonia cases 1–5 months of age was 12.5% (95% confidence interval, 4.2%–26.8%; 5/40); pertussis was identified in 3.7% of 137 in-hospital deaths among African cases in this age group. Conclusions. In the postneonatal period, pertussis causes a small fraction of hospitalized pneumonia cases and deaths; however, case fatality is substantial. The propensity to infect unvaccinated infants and those at risk for insufficient immunity (too young to be vaccinated, premature, HIV-infected/exposed) suggests that the role for maternal vaccination should be considered along with efforts to reduce exposure to risk factors and to optimize childhood pertussis vaccination coverage. [ABSTRACT FROM AUTHOR]

Background: Maternal group B streptococcus (GBS) serotype-specific capsular antibody concentrations are correlated with susceptibility to neonatal GBS invasive disease. Maternal immunisation against GBS during pregnancy might protect infants across the period of susceptibility to invasive disease, but no licensed vaccine exists. This study assessed the safety and immunogenicity of a CRM197-conjugated trivalent GBS vaccine in non-pregnant and pregnant women, and antibody transfer to their infants.Methods: We did a phase 1b/2, randomised, observer-blind single-centre study of an investigational trivalent GBS vaccine in healthy non-pregnant women (cohort 1), and a dose-ranging study in healthy pregnant women (cohort 2). The study was done at the Chris Hani Baragwanath Academic Hospital in Soweto, South Africa. Participants were healthy non-pregnant or pregnant (28-35 weeks' gestation) women aged 18-40 years. In cohort 1, non-pregnant women were randomly assigned (2:1) to receive the investigational vaccine (two injections, 1 month apart, of a 20 μg dose [of each serotype] of aluminium hydroxide-adjuvanted investigational vaccine) or placebo. In cohort 2, pregnant women were randomly assigned (1:1:1:1) to receive one injection at 28-35 weeks' gestation of 0·5 μg, 2·5 μg, or 5·0 μg of the non-adjuvanted investigational vaccine (for each serotype), or placebo. All study participants and study staff not involved with vaccine preparation were masked to the randomisation group. The vaccine contained an equal dose (0·5 μg, 2·5 μg, 5·0 μg, or 20 μg) of each of three glycoconjugates (serotypes Ia, Ib and III). Reactogenicity was monitored to day 7 and unsolicited adverse events (adverse events) and infant safety were recorded throughout the study. The primary outcomes were tolerability and GBS-specific antibody response (measured as geometric mean concentrations [GMCs] in μg/mL) following the two injections for cohort 1, and selection of one vaccine dose based on analysis of serotype-specific antibody responses at delivery (+72 h) for use in subsequent studies. These outcomes were assessed in participants or infants of participants who correctly received the study vaccine with no major protocol deviations, and provided evaluable serum samples at day 1 and the scheduled timepoints throughout the study. This study is registered with ClinicalTrials.gov, NCT01193920.Findings: Between Oct 5, 2010, and Sept 21, 2011, we screened 75 non-pregnant and 417 pregnant healthy South African women. Of these, 60 non-pregnant women were enrolled in cohort 1 (40 randomly assigned to the GBS 20 μg group and 40 randomly assigned to the placebo group) and 320 pregnant women were enrolled in cohort 2 (80 in each of the four groups). Among the randomised groups of pregnant women, 33-40% experienced at least one local and 54-71% one systemic solicited adverse event, less than 4% of which were severe, and the rate did not differ by study group. Also, 2% of the pregnancies resulted in stillbirth and 3·5% of the liveborn babies died by 12 months age, none of these deaths were attributed to vaccination. There was one death in a GBS-vaccine recipient, which too was unrelated to vaccination. For cohort 1, serotype-specific antibody concentrations were significantly higher, as evident by no overlap of the 95% CIs of GMCs against all three serotypes in the vaccinated group than the placebo group. For cohort 2, pregnant women in all vaccine groups had significantly higher GMCs than did those in the placebo group at delivery (eg, GMCs against serotype Ia were 11 μg/mL [95% CI 7·0-18] for the GBS vaccine 0·5 μg group, 18 μg/mL [11-29] for the GBS vaccine 2·5 μg group, 22 μg/mL [13-35] for the GBS vaccine 5·0 μg group, and 0·64 μg/mL [0·42-0·98] for the placebo group) and at all measured timepoints. GMCs did not differ significantly between the vaccine doses at any of the measured timepoints (p>0·05).Interpretation: The vaccine was well tolerated and induced capsular-specific antibody responses, in non-pregnant and pregnant women. Maternal vaccination led to higher GBS serotype-specific antibody concentrations in infants than did placebo, with both interventions resulting in similar safety profiles.Funding: Novartis Vaccines and Diagnostics division, now part of the GlaxoSmithKline group of companies. [ABSTRACT FROM AUTHOR]

Maternal pertussis vaccination is associated with higher levels of pertussis antibodies at birth. We assessed the persistence of pertussis antibodies until primary vaccination in infants whose mothers received Tdap (tetanus, diphtheria, acellular pertussis) vaccine during pregnancy. Infants were born at the Hospital Clinic of Barcelona (Spain) in November 2014. Anti-PT IgG was determined by ELISA at delivery, between the first and second month of life, and estimated at 2 months of age. The study included 37 infants whose mothers received Tdap between 21 and 38 weeks of gestation. Infants presented a decline in GMC of anti-PT IgG between peripartum and follow-up levels, 52.7 (95% CI 34.7–80.2) versus 7.5 (95% CI 4.2–13.3) at 2 months of age ( p < 0.001). The median half-life of maternal antibodies was 47 days. More than half (51.4%) the infants presented detectable anti-PT IgG before the start of primary infant vaccination. [ABSTRACT FROM AUTHOR]

Background: The burden of rotavirus morbidity and mortality is high in children aged <5 years in developing countries, and evaluations indicate waning protection from rotavirus immunization in the second year. An additional dose of rotavirus vaccine may enhance the immune response and lengthen the period of protection against disease, but coadministration of this dose should not interfere with immune responses to concurrently given vaccines.Methods: A total of 480 9-month-old participants from Matlab, Bangladesh, were enrolled in a study with a primary objective to establish noninferiority of concomitant administration of measles-rubella vaccine (MR) and a third dose of human rotavirus vaccine (HRV; MR + HRV), compared with MR given alone. Secondary objectives included noninferiority of rubella antibody seroconversion and evaluating rotavirus IgA/IgG seroresponses in MR + HRV recipients.Results: Two months after vaccination, 75.3% and 74.3% of MR + HRV and MR recipients, respectively, had seroprotective levels of measles virus antibodies; 100.0% and 99.6%, respectively, showed anti-rubella virus immunoglobulin G (IgG) seroprotection. In the MR + HRV group, antirotavirus immunoglobulin A and IgG seropositivity frequencies before vaccination (52.7% and 66.3%, respectively) increased to 69.6% and 88.3% after vaccination.Conclusions: Vaccine-induced measles and rubella antibody responses are not negatively affected by concomitant administration of HRV. The HRV dose increases antirotavirus serum antibody titers and the proportion of infants with detectable antirotavirus antibody.Clinical Trials Registration: NCT01700621. [ABSTRACT FROM AUTHOR]

This comparative study explores incertitude about hepatitis B (HBV) and its implications for childhood vaccination in Bangui, Central African Republic, and the Cascades region, Burkina Faso. Anthropological approaches to vaccination, which counter stereotypes of "ignorant" publics needing education to accept vaccination, excavate alternative ways of knowing about illness and vaccination. We build on these approaches, evaluating different kinds of incertitude (ambiguity, uncertainty, ignorance) about infancy, HBV, health protection, and vaccination. Using interviews and participant observation, we find that Bangui and Cascades publics framed their incertitude differently through stories of infancy, illness, and protection. We locate different forms of incertitude within their historical contexts to illuminate why vaccination practices differ in the Cascades region and Bangui. A more nuanced approach to incomplete knowledge, situated in political, economic, and social histories of the state and vaccination, can contribute to more appropriate global health strategies to improve HBV prevention. [ABSTRACT FROM AUTHOR]

Recently, HLA-DP single nucleotide polymorphisms (SNPs) have been reported to be related to responsiveness to hepatitis B virus (HBV) vaccination. The aim of this study was to investigate associations between HLA-DP SNPs and responsiveness to HBV vaccine in Korean infants. A total of 290 healthy Korean infants who were registered to Seoul Metropolitan Public Cord Blood Bank during the period of February 2007 to December 2011 were enrolled. Anti-HBs antibody level was analyzed after three doses of HBV vaccination. Genotyping of HLA-DPA1 SNPs (rs3077 and rs3830066) and HLA-DPB1 SNPs (rs7770370, rs7770501, rs3128961, and rs9277535) were performed by PCR-sequencing. HLA-A, -B , and – DRB1 genotyping was also performed by PCR-sequence-specific oligonucleotide probe kits. HLA-DPB1 SNPs (rs7770370, rs7770501, rs3128961, and rs9277535) were associated with HBV vaccine response. Allele frequencies of rs7770370 A, rs7770501 C, rs3128961 G, and rs9277535 A were significantly higher in responders than in non-responders (all p < 0.01). Anti-HBs antibody levels were different according to genotypes of DPB1 rs7770370, rs7770501, rs3128961, and rs9277535 (all p < 0.01). In multivariate analysis, HLA-DPB1 rs7770370 AA genotype was significantly associated with HBV vaccine response (relative risk, RR = 2.5, p = 0.033) and high-titer vaccine response (RR = 2.7, p < 0.001). In conclusion, HLA-DPB1 SNPs were significantly associated with responses to HBV vaccination in Korean infants. [ABSTRACT FROM AUTHOR]

Background Acute respiratory infection (ARI) is the most frequent reason for children being seen by doctors worldwide. We aimed to estimate the frequency of complications in children aged 6–23 months during ARI episode and to evaluate risk factors present on recruitment associated with complications after the universal implementation of pneumococcal vaccine (PCV10) in our region. Methods This prospective cohort enrolled children who had shown ARI for up to 7 days and who were subsequently followed up 14–21 days after, in Salvador, Brazil. Data on recruitment were registered. The vaccine card was personally checked. Complication was defined when hospitalization, pneumonia or acute otitis media (AOM) were informed during the follow-up visit. Pneumonia and AOM were diagnosed by a doctor. Multiple logistic regression analysis was performed. Results Of 576 children, 422 (73%) returned and 79 (19%; 95%CI: 15–23%) had complications. The mean interval between admission and follow-up was 23 ± 13 days. Pneumonia ( n = 47; 11%), hospitalization ( n = 28; 7%), and AOM ( n = 17; 4%) were reported. Most of the patients presented one complication ( n = 66; 84%) followed by two ( n = 13; 16%). Report of fever (92% versus 79%; OR [95%CI]: 2.90 [1.18–7.14]), bird at home (24% versus 14%; OR [95%CI]: 2.13 [1.07–4.26]), ronchi (48% versus 36%; OR [95%CI]: 2.06 [1.16–3.67]) or crackles (17% versus 7%; OR [95%CI]: 2.36 [1.04–5.38]) on auscultation were directly associated with complications whereas PCV10 (59% versus 75%; OR [95%CI]: 0.46 [0.26–0.82]) was inversely associated. Bird at home (OR [95%CI]: 5.80 [1.73–19.38]) and ronchi (OR [95%CI]: 6.39 [1.96–20.85]) were associated with AOM; PCV10 was inversely associated with AOM (OR [95%CI]: 0.16 [0.05–0.52]). Crackles were associated with pneumonia (OR [95%CI]: 2.55 [1.01–6.40]). Conclusions One fifth of the children presented complications. PCV10 was independently associated with lower odds of development of AOM. Bird at home and ronchi are risk factors of otitis. Crackles are associated with pneumonia. [ABSTRACT FROM AUTHOR]

Background: Dravet syndrome is a rare epileptic encephalopathy characterized by treatment-resistant polymorphic seizures. Seizure onset usually occurs during the first year of life, and seizures are often associated with heat-related triggering factors (e.g., fever, photosensitivity, or hot bath). It has been reported that children with Dravet syndrome often present with recurrent febrile seizures and vaccination-related seizures.Methods: We analyzed the occurrence of vaccination-related seizures (defined as the development of a seizure within 48 hours post vaccination) in 54 patients with Dravet syndrome. Patients were divided into two groups according to whether seizures occurred within 48 hours of vaccination (i.e., vaccination-proximate group) or not (vaccination-distant group).Results: There was no significant difference in the vaccination-proximate group and vaccination-distant group for the presence of SCN1A mutation. In our Dravet syndrome cohort, the vaccination-proximate group consisted of 17 (31.5%) patients with Dravet syndrome. Thus vaccination-related seizures are a common triggering factor in Dravet syndrome, reported in up to one third of our patients.Conclusion: Vaccination-related seizures may act as the triggering factor for the onset of seizures in children with Dravet syndrome, especially before the definitive diagnosis of Dravet syndrome can be made within the first year of life. We suggest further study of guidelines and protocols for the prevention and management of vaccination-related seizures in children with recurrent febrile seizures pending a definitive diagnosis of Dravet syndrome in the first 12 months of life. [ABSTRACT FROM AUTHOR]

Objective To map the acceptability to parents in Togo of infant vaccination against malaria. Methods From July to October 2014, a study of 209 parents of infants in Togo was conducted to assess their willingness to have their infants vaccinated against malaria. Participants were exposed to 48 vignettes, designed using the main constructs of health-protective theories. Results Five qualitatively different positions were found, which were labeled Neighbors’ Attitude (5%), Cost Only (21%), Neighbors’ Attitude and Cost (22%), Risk and Cost (33%), and Always Vaccine (20%). Conclusion The diversity of parental positions regarding vaccinating their infants against malaria implies that malaria vaccination campaigns in Togo, and possibly in other sub-Saharan African countries, must not be “one size fits all,” but must be tailored in design and implementation to match the diversity of parents’ needs and views. [ABSTRACT FROM AUTHOR]

Group B Streptococcus (GBS), a commensal organism, can turn into a life-threatening pathogen in neonates and elderly, or in adults with severe underlying diseases such as diabetes. We developed a vaccine targeting the GBS glyceraldehyde-3-phosphate dehydrogenase (GAPDH), a glycolytic enzyme detected at the bacterial surface, which was proven to be effective in a neonatal mouse model of infection. Since this bacterium has emerged as an important pathogen in non-pregnant adults, here we investigated whether this vaccine also confers protection in an adult susceptible and in a diabetic mouse model of infection. For immunoprotection studies, sham or immunized adult mice were infected with GBS serotype Ia and V strains, the two most prevalent serotypes isolated in adults. Sham and vaccinated mice were also rendered diabetic and infected with a serotype V GBS strain. For toxicological (pre-clinical) studies, adult mice were vaccinated three times, with three concentrations of recombinant GAPDH adjuvanted with Allydrogel, and the toxicity parameters were evaluated twenty-four hours after the last immunization. For the stability tests, the vaccine formulations were maintained at 4°C for 6 and 12 months prior immunization. The results showed that all tested doses of the vaccine, including the stability study formulations, were immunogenic and that the vaccine was innocuous. The organs (brain, blood, heart, and liver) of vaccinated susceptible or diabetic adult mice were significantly less colonized compared to those of control mice. Altogether, these results demonstrate that the GAPDH-based vaccine is safe and stable and protects susceptible and diabetic adult mice against GBS infections. It is therefore a promising candidate as a global vaccine to prevent GBS-induced neonatal and adult diseases. [ABSTRACT FROM AUTHOR]

Background: We aimed to assess the effects of administering prophylactic acetaminophen on short-term complications of vaccination in 6-month-old infants admitted to a private pediatric clinic in Rasht (Iran) during 2002-2013. Methods: This quasi-experimental study was conducted on 696, infants aged 6-month-old admitted to a pediatric clinic in Rasht before vaccination during 2002-2013. Overall, 31 infants were excluded during the course of the study. While prophylactic acetaminophen was administered in 322 participants (intervention group), 343 infants (control group) received acetaminophen after vaccination. Data were collected by a checklist including complications such as fever, drowsiness, anorexia, seizure, long and excessive crying, mood change, pain, and wound at the site of injection, abscess, induration, limb swelling, and erythema. The time of occurrence of each complication was also recorded. Data were analyzed by Chi-square test in SPSS 16.0. P < 0.05 was considered significant. Results: Six hundred sixty-five participants (49.6% boy) were assessed in this study. The intervention and control groups had no significant difference in terms of sex distribution (P = 0.53). Short-term complications occurred in 45% of the infants. The most common complications were erythema (24.4%), induration (19.9%), and low-grade fever (16.1%). There was a significant relation between administering prophylactic acetaminophen and the incidence of low-grade fever (P = 0.01), induration (P = 0.01), and anorexia (P = 0.03). Conclusions: Our findings indicated the efficacy of prophylactic acetaminophen in reducing postvaccination complications in a population of Iranian infants. According to our findings, further research is required to determine the preferred dose and time of administering acetaminophen. [ABSTRACT FROM AUTHOR]

Background. Yellow fever (YF) is still a major public health problem in endemic regions of Africa and South America. In Africa, one of the main control strategies is routine vaccination within the Expanded Programme on Immunization (EPI). A new meningococcal A conjugate vaccine (PsA-TT) is about to be introduced in the EPI of countries in the African meningitis belt, and this study reports on the immunogenicity of the YF-17D vaccines in infants when administered concomitantly with measles vaccine and PsA-TT. Methods. Two clinical studies were conducted in Ghana and in Mali among infants who received PsA-TT concomitantly with measles and YF vaccines at 9 months of age. YF neutralizing antibody titers were measured using a microneutralization assay. Results. In both studies, the PsA-TT did not adversely affect the immune response to the concomitantly administered YF vaccine at the age of 9 months. The magnitude of the immune response was different between the 2 studies, with higher seroconversion and seroprotection rates found in Mali vs Ghana. Conclusions. Immunogenicity to YF vaccine is unaffected when coadministered with PsA-TT at 9 months of age. Further studies are warranted to better understand the determinants of the immune response to YF vaccine in infancy. [ABSTRACT FROM AUTHOR]

Background: Adapting educational tools to meet user needs is a critical aspect of translating research evidence into best clinical practices. The objectives of this study were to evaluate usability and effectiveness of educational tools about infant vaccination pain management directed to postnatal nurses. Methods: Mixed methods design. A template pamphlet and video included in a published clinical practice guideline were subjected to heuristic usability evaluation and then the revised tools were reviewed by postnatal hospital nurses in three rounds of interviews involving 8 to 12 nurses per round. Nurses' knowledge about evidence-based pain management interventions was evaluated at three time points: baseline, after pamphlet review, and after video review. Results: Of 32 eligible postnatal nurses, 29 agreed to participation and data were available for 28. Three overarching themes were identified in the interviews: 1) utility of information, 2) access to information, and 3) process for infant procedures. Nurses' knowledge improved significantly (p < 0.05) from the baseline phase to the pamphlet review phase, and again from the pamphlet review phase to the video review phase. Conclusions: This study demonstrated usability and knowledge uptake from a nurse-directed educational pamphlet and video about managing infant vaccination pain. Future studies are needed to determine the impact of implementing these educational tools in the postnatal hospital setting on parental utilization of analgesic interventions during infant hospitalization and future infant vaccinations. [ABSTRACT FROM AUTHOR]

Objective Sucrose solutions are analgesic in infants. Oral rotavirus vaccine contains sucrose, however, it is not known if it possesses analgesic properties. The objective was to compare the analgesic effectiveness of rotavirus vaccine to sucrose solution when administered prior to injectable vaccines. Methods Infants 2–4 months of age receiving oral rotavirus vaccine and two separate injectable vaccines on the same day were randomized to rotavirus vaccine (Rotarix™) first followed by the injectable vaccines and sucrose (Tootsweet™) afterwards, or vice versa. Pain was assessed by blinded raters using the Numerical Rating Scale (NRS, range 0–10) (parents, clinicians), or Modified Behavioural Pain Scale (MBPS, range 0–10) and cry duration (observers). Data were analyzed using t -tests or χ 2 -tests; Bonferroni correction was applied to correct for multiple comparisons, as appropriate. Results Altogether, 120 infants participated: 60 were randomized to rotavirus vaccine first. Groups did not differ in demographics, including; age ( p = 0.448) and sex ( p = 0.464). The mean pain score (standard deviation) for both vaccine injections did not differ between infants given rotavirus vaccine first versus sucrose solution first: observer MBPS, parent NRS and clinician NRS scores were 7.4 (1.6) vs. 7.7 (1.6), 4.9 (2.1) vs. 5.8 (2.1), and 4.2 (2.1) vs. 4.6 (2.2), respectively. Similarly, there was no difference between groups in cry duration. Conclusion Rotavirus vaccine did not differ from sucrose solution in reducing injection-induced pain. Based on the findings, it is recommended that rotavirus vaccine be administered prior to injectable vaccines in infants aged 2 and 4 months. [ABSTRACT FROM AUTHOR]

Background Streptococcus pneumoniae infections are a major cause of morbidity and mortality in children <5 years old worldwide. To increase serotype coverage globally, a 13-valent pneumococcal conjugate vaccine (PCV13) has been developed and approved in many countries worldwide. Objective Assess the safety and immunogenicity of PCV13 in healthy older infants and children naïve to previous pneumococcal vaccination. Methods This was a phase 3, open-label, multicenter study conducted in Polish children ( N = 354) who were vaccinated according to 3 age-appropriate catch-up schedules: Group 1 (aged 7 to <12 months) received two PCV13 doses with a booster at 12–16 months of age; Group 2 (aged 12 to <24 months) received two vaccine doses only; and Group 3 (aged 24 to <72 months) received a single dose of PCV13. Statistical analyses were descriptive. The proportion of immunological “responders” achieving serotype-specific antipneumococcal polysaccharide concentrations ≥0.35 μg/mL, 1-month after the last dose of vaccine, was determined for each vaccine serotype. In addition, antipolysaccharide immunoglobulin (Ig) G geometric mean concentrations (GMCs) were calculated. Safety assessments included systemic and local reactions, and adverse events. Results The proportion of immunological responders was ≥88% across groups for all serotypes. Antipolysaccharide IgG GMCs were generally similar across groups. Each schedule elicited immune response levels against all 13 serotypes comparable to or greater than levels previously reported in infants after a 3-dose series. The 3 catch-up schedules had similar tolerability and safety profiles; a trend was present towards greater local tenderness with increasing age and subsequent dose administration. Conclusions Immunological responses and safety results support the use of PCV13 for catch-up schedules in older infants and children naïve to pneumococcal vaccination. [ABSTRACT FROM AUTHOR]

Educating parents about ways to minimize pain during routine infant vaccine injections at the point of care may positively impact on pain management practices. The objective of this cluster randomized trial was to determine the impact of educating parents about pain in outpatient pediatric clinics on their use of pain treatments during routine infant vaccinations. Four hospital-based pediatric clinics were randomized to intervention or control groups. Parents of 2- to 4-month-old infants attending the intervention clinics reviewed a pamphlet and a video about vaccination pain management on the day of vaccination, whereas those in the control clinics did not. Parent use of specific pain treatments (breastfeeding, sugar water, topical anesthetics, and/or holding of infants) on the education day and at subsequent routine vaccinations 2 months laterwas the primary outcome. Altogether, 160 parent-infant dyads (80 per group) participated between November 2012 and February 2014; follow-up data were available for 126 (79%). Demographics did not differ between groups (P>0.05).On the education day and at follow-up vaccinations, use of pain interventions during vaccinations was higher in the intervention group (80%vs 26% and 68%vs 32%, respectively; P<0.001 for both analyses). Educating parents about pain management in a hospital outpatient setting leads to higher use of pain interventions during routine infant vaccinations. [ABSTRACT FROM AUTHOR]

There are important interactions between vaccines, and between vaccines and unrelated (heterologous) infections. In high-mortality regions, until the next vaccine is given, live vaccines such as bacillus Calmette-Guérin (BCG) and measles vaccines reduce mortality from infections such as pneumonia and sepsis. However, non-live vaccines such as diphtheria, tetanus and whole-cell pertussis vaccine (DTP) may increase mortality from infections other than diphtheria, tetanus and pertussis. All-cause mortality might be reduced if an extra dose of Edmonston-Zagreb measles vaccine were given at 20 weeks of age, 4–6 weeks after the third dose of DTP, with no subsequent doses of DTP in girls, and no vitamin A in girls or boys before the second dose of measles vaccine at 9 months of age. Policy should change to increase the proportion of babies given BCG and oral polio vaccine at birth, and should recognize the important differences between BCG, DTP and measles vaccines produced by different manufacturers. [ABSTRACT FROM AUTHOR]

We used a claims database to assess coverage for rotavirus (RV), diphtheria-tetanus-acellular pertussis, and pneumococcal conjugate vaccines among infants in the United States. Similar coverage was seen until 7 months of age, after which RV coverage lagged. Missed opportunities for vaccination at well-child visits were found to vary by age. [ABSTRACT FROM AUTHOR]

The 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) (Synflorix™) includes ten serotype-specific polysaccharides of Streptococcus pneumoniae, eight of which are conjugated individually to a nonlipidated cell-surface lipoprotein (protein D) of non-typeable H. influenzae and two of which are conjugated to nontoxic tetanus or diphtheria toxoid carrier proteins. This article provides an overview of the well-established immunogenicity of PHiD-CV, including functional immune responses and immunologic memory, as well as immune responses in preterm infants and HIV-infected children. It also includes a brief discussion of cross-protection against vaccine-related serotypes (6A and 19A) and focuses on labelling in the EU, where PHiD-CV is approved for active immunization against invasive disease, pneumonia, and acute otitis media (AOM) caused by S. pneumoniae in infants and young children up to 5 years of age. Evidence of the protective efficacy and effectiveness of PHiD-CV against pneumococcal diseases is available from several studies, including the randomized, double-blind trials COMPAS (Clinical Otitis Media and Pneumonia Study) and FinIP (Finnish Invasive Pneumococcal disease), as well as postmarketing studies from various countries. As would be expected, protection against pneumonia or AOM is substantially lower than that against invasive pneumococcal disease, as many micro-organisms other than pneumococcal vaccine serotypes can cause pneumonia and AOM, thereby limiting the overall protection of PHiD-CV against these diseases. PHiD-CV has a safety and reactogenicity profile similar to that of other pneumococcal conjugate vaccines. [ABSTRACT FROM AUTHOR]

Justification: There is a need to review/revise recommendations about existing vaccines in light of recent developments in the field of vaccinology. Process: Following an IAP ACVIP meeting on April 19 and 20, 2014, a draft of revised recommendations for the year 2014 and updates on certain vaccine formulations was prepared and circulated among the meeting participants to arrive at a consensus. Objectives: To review and revise recommendations for 2014 Immunization timetable for pediatricians in office practice and issue statements on certain new and existing vaccine formulations. Recommendations: The major changes in the 2014 Immunization Timetable include two doses of MMR vaccine at 9 and 15 months of age, single dose recommendation for administration of live attenuated H2 strain hepatitis A vaccine, inclusion of two new situations in 'high-risk category of children' in context with 'pre-exposure prophylaxis' of rabies, creation of a new slot at 9-12 months of age for typhoid conjugate vaccine for primary immunization, and recommendation of two doses of human papilloma virus vaccines with a minimum interval of 6 months between doses for primary schedule of adolescent/ preadolescent girls aged 9-14 years. There would not be any change to the committee's last year's (2013) recommendations on pertussis vaccination and administration schedule of monovalent human rotavirus vaccine. There is no need of providing additional doses of whole-cell pertussis vaccine to children who have earlier completed their primary schedule with acellular pertussis vaccine-containing products. A brief update on the new Indian Rotavirus vaccine, 116E is also provided. The committee has reviewed and offered its recommendations on the currently available pentavalent vaccine (DTwP+Hib+Hepatitis-B) combinations in Indian market. The comments and footnotes for several vaccines are also updated and revised. [ABSTRACT FROM AUTHOR]

Introduction An increasing proportion of childhood immunization visits include administration of multiple injections. Future introduction of vaccines to protect against multiple diseases will further increase the number of injections at routine immunization childhood visits, particularly in developing countries that are still scaling up introductions. Parental and healthcare provider attitudes toward multiple injections may affect acceptance of recommended vaccines, and understanding these attitudes may help to inform critical decisions about vaccine introduction. Methods We conducted a systematic review of the literature to examine factors underlying reported parental and healthcare provider concerns and practices related to administration of multiple injections during childhood vaccination visits. Results Forty-four articles were identified; 42 (95%) were from high income countries, including 27 (61%) from the USA. Providers and parents report concerns about multiple injections, which tend to increase with increasing numbers of injections. Common parental and provider concerns included apprehension about the pain experienced by the child, worry about potential side effects, and uncertainty about vaccine effectiveness. Multiple studies reported that a positive provider recommendation to the parent and a high level of concern about the severity of the target disease were significantly associated with parental acceptance of all injections. Providers often significantly overestimated parental concerns about multiple injections. Discussion Providers may play a critical role in the decision for a child to receive all recommended injections. Their overestimation of parental concerns may lead them to postpone recommended vaccinations, which may result in extra visits and delayed vaccination. More research is needed on interventions to overcome provider and parental concern about multiple injections, particularly in developing countries. [ABSTRACT FROM AUTHOR]

Background. The rising prevalence of atopic diseases during last decades brings concern for the "Western life-style" countries. Although there is general consensus on the importance of the genetic predisposition for atopic disorders (asthma, allergic rhinitis, atopic dermatitis), only changes in environmental factors can explain the rise of allergic diseases during the last forty years. Vaccinations in infancy have been incriminated as an additional risk factor for development of atopic diseases. A potential relationship between vaccination and atopy could be analysed by two directions: either by activation of the Th2 network in the vaccine-specific memory response, or exposition to (attenuated or inactivated) pathogens or their components at a very young age of vaccinated children and possible promotion of Th1 proliferation. Materials and methods. The major electronic databases (Medline, Cochrane Library) were searched using key words: vaccination, atopy, relationship and children. Recent studies analysing a relationship between atopic disorders and vaccination in infancy were reviewed. Moreover, possible mechanisms of immune response to vaccines in atopic children were analysed. Results. Available evidence is rather convincing that the current regular childhood vaccination does not increase the risk of atopic disorders. Large epidemiological, prospective, cohort and multi-central studies all over the world published in last 10 years with quite large proportions of unvaccinated children included showed that vaccination in infancy was not related to development of atopic conditions starting from the first year of life up to the middle age. Even conversely, some studies detected that vaccinated children had a moderately reduced rate of atopic diseases. It was also denoted that atopy could be suppressed due to high vaccination coverage. Conclusions. Allergic or atopic children just like non-atopic children require routine immunization to be protected from serious life and health threatening viral and bacterial infections. The risks of infection by vaccine avoidance outweigh by far the possible minimal risks of immunization, moreover, anti-infectious treatment or natural infection (like pertussis) per se could be potential triggers of atopic disorders. [ABSTRACT FROM AUTHOR]

Abstract: Analgesic interventions are not routinely used during vaccine injections in infants. Parents report a desire to mitigate injection pain, but lack the knowledge about how to do so. The objective of this cluster-randomized trial was to evaluate the effect of a parent-directed prenatal education teaching module about vaccination pain management on analgesic utilization at future infant vaccinations. Expectant mothers enrolled in prenatal classes at Mount Sinai Hospital in Toronto were randomized to a 20-30minute interactive presentation about vaccination pain management (experimental group) or general vaccination information (control group). Both presentations included a PowerPoint (Microsoft Corporation, Redmond, WA, USA) and video presentation, take-home pamphlet, and “Question and Answer” period. The primary outcome was self-reported utilization of breastfeeding, sugar water, or topical anaesthetics at routine 2-month infant vaccinations. Between October 2012 and July 2013, 197 expectant mothers from 28 prenatal classes participated; follow-up was obtained in 174 (88%). Maternal characteristics did not differ (P >0.05) between groups. Utilization of one or more prespecified pain interventions occurred in 34% of participants in the experimental group, compared to 17% in the control group (P =0.01). Inclusion of a pain management module in prenatal classes led to increased utilization of evidence-based pain management interventions by parents at the 2-month infant vaccination appointment. Educating parents offers a novel and effective way of improving the quality of pain care delivered to infants during vaccination. Additional research is needed to determine if utilization can be bolstered further using techniques such as postnatal hospital reinforcement, reminder cards, and clinician education. [Copyright &y& Elsevier]

Background. In Uganda, the tuberculosis vaccine BCG is administered on the first day of life. Infants delivered at home receive BCG vaccine at their first healthcare facility visit at 6 weeks of age. Our aim was to determine the effect of this delay in BCG vaccination on the induced immune response.Methods. We assessed CD4+ and CD8+ T-cell responses with a 12-hour whole-blood intracellular cytokine/cytotoxic marker assay, and with a 6-day proliferation assay.Results. We enrolled 92 infants: 50 had received BCG vaccine at birth and 42 at 6 weeks of age. Birth vaccination was associated with (1) greater induction of CD4+ and CD8+ T cells expressing either interferon γ (IFN-γ) alone or IFN-γ together with perforin and (2) induction of proliferating cells that had greater capacity to produce IFN-γ, tumor necrosis factor α (TNF-α), and interleukin 2 together, compared with delayed vaccination.Conclusions. Distinct patterns of T-cell induction occurred when BCG vaccine was given at birth and at 6 weeks of age. We propose that this diversity might impact protection against tuberculosis. Our results differ from those of studies of delayed BCG vaccination in South Africa and the Gambia, suggesting that geographical and population heterogeneity may affect the BCG vaccine–induced T-cell response. [ABSTRACT FROM PUBLISHER]

Abstract: The morbidity and mortality related to many communicable infectious diseases have significantly decreased in Western countries largely because of the use of antibiotics, and the implementation of well-planned vaccination strategies and national immunisation schedules specifically aimed at infants and children. However, although immunisation has proved to be highly effective for public health, more effort is needed to improve the currently sub-optimal rates of vaccination against various diseases among adults who may be at risk because of their age, medical condition or occupation. The vaccines currently licenced in Western countries are safe, immunogenic and effective against many infectious diseases and their complications, but the availability of newer vaccines or vaccines with new indications, the evolving ecology and epidemiology of many infections, population ageing, and other demographic changes (i.e. the increasing prevalence of chronic comorbidities and immunodeficiencies, mass migration, new working relationships, and widespread international tourism) require changes in the approach to immunisation. There is now a need for appropriate preventive measures for adults and the elderly aimed at protecting people at risk by using every possible catch-up opportunity and recommending specific age-related schedules on the basis of local epidemiology. [Copyright &y& Elsevier]

Background: PCV7 was introduced as universal childhood vaccination in Israel in July 2009 and PCV13 in November 2010. Here we report data on adult invasive pneumococcal disease (IPD), two years post PCV7 implementation and before an expected effect of PCV13. Methods: An ongoing nationwide active-surveillance (all 27 laboratories performing blood cultures in Israel), providing all blood & CSF S. pneumoniae isolates from persons >18 y was initiated in July 2009. Capture-recapture method assured reporting of >95% cases. All isolates were serotyped in one central laboratory. IPD outcome and medical history were recorded in 90%. Second year post PCV implementation is compared to the first year. Results: During July 2009 to June 2011, 970 IPD cases were reported (annual incidence [/100,000] of 9.17 and 10.16 in the two consecutive years, respectively). Respective case fatality rates (CFRs) were 20% and 19.1%. Incidence of IPD and CFR increased with age and number of comorbidities. Incidence rate was significantly greater during the second winter, 7.79/100,000 vs. 6.14/100,000 in first winter, p = 0.004, with a non-significant decrease during summer months (3.02 to 2.48/100,000). The proportion of IPD cases due to PCV7-serotypes decreased from 27.5% to 13.1% (first to second year) (p<0.001). Yet, non-PCV13-strains increased from 32.7% to 40.2% (p = 0.017). The increase in non-PCV13-strains was highly significant in immunocompromised patients and to a lesser degree in non-immunocompromised at risk or in older patients (>64 y). Among younger/healthier patients serotype 5 was the major increasing serotype. Penicillin and ceftriaxone resistance decreased significantly in the second year. Conclusions: While overall annual incidence of IPD did not change, the indirect effect of PCV7 vaccination was evident by the significant decrease in PCV7 serotypes across all age groups. Increase in non-VT13 strains was significant in immunocompromised patients. A longer follow-up is required to appreciate the full effect of infant vaccination on annual IPD. [ABSTRACT FROM AUTHOR]

Aim The aim of this study was to evaluate whether mannose-binding lectin ( MBL) plays a role in the development of osteitis after Bacillus Calmette-Guerin ( BCG) vaccination as a newborn. Methods Blood samples were obtained from 132 former BCG osteitis patients, now aged 21-49 years, and analysed for MBL concentration and MBL2 genotype in a controlled setting. Results Variant genotypes in the MBL2 gene were more common in the former BCG osteitis patients (42.4%) than in the population controls (32.3%, p = 0.033). However, MBL concentrations at the age of 21-49 years were not lower in these patients than in the controls in the same age group. The variant MBL2 genotypes were associated with low serum MBL concentrations, and moreover, MBL concentration was not measurable in two of those three patients who were homozygous for the variant MBL2 genotype. Low serum MBL concentrations were not associated with any illnesses in the medical history of the BCG patients, their siblings or children. Conclusion Preliminary evidence was found that variant, low- MBL-producing genotypes may be associated with the increased risk of BCG osteitis in vaccinated newborns. [ABSTRACT FROM AUTHOR]