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Antipyretic analgesics are commonly used to prevent and treat adverse events following immunizations. Current practice discourages routine use due to possible blunting of vaccine immune responses. We surveyed 150 parents/caregivers of recently vaccinated 6- and 15-month-old children to determine the prevalence of and beliefs regarding antipyretic analgesics use around vaccinations. 11% used them prophylactically, before vaccination. Use in the first 48 hours after vaccination was 64%, primarily to prevent and/or treat fever and pain. Acetaminophen was administered 2.6 times more frequently than ibuprofen. Ibuprofen was used more in the 15-month compared with the 6-month-old children (28% vs 7.4%, respectively, P = .001). The majority of caregivers disagreed with their use for fever (53%) or pain (59%). Antipyretic analgesic use, including prophylaxis, around vaccinations was common in our study population. Effective interventions are needed to target parents/caregivers to eliminate unnecessary antipyretic analgesic use around vaccination time and foster nonmedication alternatives.

Objectives Sources of immunization data include state registries or immunization information systems (IIS), medical records, and surveys. Little is known about the quality of these data sources or the feasibility of using IIS data for research. We assessed the feasibility of collecting immunization information for a national children's health study by accessing existing IIS data and comparing the completeness of these data against medical record abstractions (MRA) and parent report. Staff time needed to obtain IIS and MRA data was assessed. Methods We administered a questionnaire to state-level IIS representatives to ascertain availability and completeness of their data for research and gather information about data formats. We evaluated quality of data from IIS, medical records, and reports from parents of 119 National Children's Study participants at three locations. Results IIS data were comparable to MRA data and both were more complete than parental report. Agreement between IIS and MRA data was greater than between parental report and MRA, suggesting IIS and MRA are better sources than parental report. Obtaining IIS data took less staff time than chart review, making IIS data linkage for research a preferred choice. Conclusions IIS survey results indicate data can be obtained by researchers using data linkages. IIS are an accessible and feasible child immunization information source and these registries reduce reliance on parental report or medical record abstraction. Researchers seeking to link IIS data with large multi-site studies should consider acquiring IIS data, but may need strategies to overcome barriers to data completeness and linkage.

Validity of prenatal immunization data from different sources has not been assessed. We evaluated prenatal 2009 H1N1 and seasonal influenza (FLU) data obtained from state immunization information systems (IIS), medical record abstraction (MRA), and participant recall using medical care logs (NCS-MCL). 2009 H1N1 and FLU data were obtained from IIS and MRA for 325 pregnant women participating in the National Children's Study at three locations (SD/MN, NC, WI). Women recalled immunizations at first pregnancy visit and at 16-17 and 36 weeks' gestation (NCS-MCL). The proportion of women with vaccine information obtainable from each data source was determined, and proportions immunized as determined using different data sources were compared. IIS data were available for 82%, MRA for 97%, and NCS-MCL for 93% of women. No mention of either vaccine occurred in 29% (range 4-48%) of IIS, 40% of MRA (25-59%), and 59% (43-82%) in NCS-MCL. Best agreement between sources was 2009 H1N1 vaccine in MRA versus IIS [kappa (95% CI) of 0.44 (0.32-0.55)], with poorest agreement for FLU in IIS versus NCS-MCL [0.11 (-0.03 to 0.25)]. IIS was the most sensitive method for identifying women receiving 2009 H1N1 vaccine (92%); MRA was most sensitive for FLU vaccine (81%). IIS provided the most complete and sensitive data for 2009 H1N1 immunizations and MRA the most complete and sensitive data for FLU; IIS data were available for a smaller percent of population than MRA. NCS-MCL was the least sensitive method for identifying vaccinated women.

BackgroundInfluenza viruses cause substantial annual morbidity and mortality globally. Current vaccines protect against influenza only when well matched to the circulating strains. However, antigenic drift can cause considerable mismatches between vaccine and circulating strains, substantially reducing vaccine effectiveness. Moreover, current seasonal vaccines are ineffective against pandemic influenza, and production of a vaccine matched to a newly emerging virus strain takes months. Therefore, there is an unmet medical need for a broadly protective influenza virus vaccine. We aimed to test the ability of chimeric H1 haemagglutinin-based universal influenza virus vaccine candidates to induce broadly cross-reactive antibodies targeting the stalk domain of group 1 haemagglutinin-expressing influenza viruses.MethodsWe did a randomised, observer-blinded, phase 1 study in healthy adults in two centres in the USA. Participants were randomly assigned to one of three prime-boost, chimeric haemagglutinin-based vaccine regimens or one of two placebo groups. The vaccine regimens included a chimeric H8/1, intranasal, live-attenuated vaccine on day 1 followed by a non-adjuvanted, chimeric H5/1, intramuscular, inactivated vaccine on day 85; the same regimen but with the inactivated vaccine being adjuvanted with AS03; and an AS03-adjuvanted, chimeric H8/1, intramuscular, inactivated vaccine followed by an AS03-adjuvanted, chimeric H5/1, intramuscular, inactivated vaccine. In this planned interim analysis, the primary endpoints of reactogenicity and safety were assessed by blinded study group. We also assessed anti-H1 haemagglutinin stalk, anti-H2, anti-H9, and anti-H18 IgG antibody titres and plasmablast and memory B-cell responses in peripheral blood. This trial is registered with ClinicalTrials.gov, number NCT03300050.FindingsBetween Oct 10, 2017, and Nov 27, 2017, 65 participants were enrolled and randomly assigned. The adjuvanted inactivated vaccine, but not the live-attenuated vaccine, induced a substantial serum IgG antibody response after the prime immunisation, with a seven times increase in anti-H1 stalk antibody titres on day 29. After boost immunisation, all vaccine regimens induced detectable anti-H1 stalk antibody (2·2-5·6 times induction over baseline), cross-reactive serum IgG antibody, and peripheral blood plasmablast responses. An unsolicited adverse event was reported for 29 (48%) of 61 participants. Solicited local adverse events were reported in 12 (48%) of 25 participants following prime vaccination with intramuscular study product or placebo, in 12 (33%) of 36 after prime immunisation with intranasal study product or placebo, and in 18 (32%) of 56 following booster doses of study product or placebo. Solicited systemic adverse events were reported in 14 (56%) of 25 after prime immunisation with intramuscular study product or placebo, in 22 (61%) of 36 after immunisation with intranasal study product or placebo, and in 21 (38%) of 56 after booster doses of study product or placebo. Disaggregated safety data were not available at the time of this interim analysis.InterpretationThe tested chimeric haemagglutinin-based, universal influenza virus vaccine regimens elicited cross-reactive serum IgG antibodies that targeted the conserved haemagglutinin stalk domain. This is the first proof-of-principle study to show that high anti-stalk titres can be induced by a rationally designed vaccine in humans and opens up avenues for further development of universal influenza virus vaccines. On the basis of the blinded study group, the vaccine regimens were tolerable and no safety concerns were observed.FundingBill & Melinda Gates Foundation.

Background With the future epidemiology and evolution of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) uncertain, the use of safe and effective coronavirus disease 2019 (COVID-19) vaccines in pediatric populations remains important. Methods We report data from two open-label substudies of an ongoing phase 1/2/3 master study (NCT05543616) investigating the safety and immunogenicity of a variant-adapted bivalent COVID-19 vaccine encoding ancestral and Omicron BA.4/BA.5 spike proteins (bivalent BNT162b2). The open-label groups presented here evaluate dose 4 with bivalent BNT162b2 in 6-month- to <12-year-olds who previously received three original (monovalent) BNT162b2 doses. In 6-month- to <5-year-olds, primary immunogenicity objectives were to demonstrate superiority (neutralizing titer) and noninferiority (seroresponse rate) to Omicron BA.4/BA.5 and noninferiority (neutralizing titer and seroresponse rate) to SARS-CoV-2 ancestral strains in participants who received bivalent BNT162b2 dose 4 compared with a matched group who received three doses of original BNT162b2 in the pivotal pediatric study (NCT04816643). In 5- to <12-year-olds, primary immunogenicity comparisons were descriptive. Reactogenicity and safety following vaccination were evaluated. Results In 6-month- to <5-year-olds, dose 4 with bivalent BNT162b2 met predefined immunogenicity superiority and noninferiority criteria against Omicron BA.4/BA.5 and ancestral strains when compared with dose 3 of original BNT162b2. In 5- to <12-year-olds, bivalent BNT162b2 induced robust Omicron BA.4/BA.5 and ancestral strain neutralizing titers comparable with dose 3 of original BNT162b2. The safety profile for dose 4 of bivalent BNT162b2 given as dose 4 was consistent with that of original BNT162b2 in 6-month- to <12-year-olds. Reactogenicity events were generally mild to moderate. No adverse events led to discontinuation. Conclusions These safety and immunogenicity data support a favorable benefit-risk profile for a variant-adapted BNT162b2 in children <12 years old. [ABSTRACT FROM AUTHOR]

Introduction A surge of human influenza A(H7N9) cases began in 2016 in China from an antigenically distinct lineage. Data are needed about the safety and immunogenicity of 2013 and 2017 A(H7N9) inactivated influenza vaccines (IIVs) and the effects of AS03 adjuvant, prime-boost interval, and priming effects of 2013 and 2017 A(H7N9) IIVs. Methods Healthy adults (n = 180), ages 19–50 years, were enrolled into this partially blinded, randomized, multicenter phase 2 clinical trial. Participants were randomly assigned to 1 of 6 vaccination groups evaluating homologous versus heterologous prime-boost strategies with 2 different boost intervals (21 vs 120 days) and 2 dosages (3.75 or 15 μg of hemagglutinin) administered with or without AS03 adjuvant. Reactogenicity, safety, and immunogenicity measured by hemagglutination inhibition and neutralizing antibody titers were assessed. Results Two doses of A(H7N9) IIV were well tolerated, and no safety issues were identified. Although most participants had injection site and systemic reactogenicity, these symptoms were mostly mild to moderate in severity; injection site reactogenicity was greater in vaccination groups receiving adjuvant. Immune responses were greater after an adjuvanted second dose, and with a longer interval between prime and boost. The highest hemagglutination inhibition geometric mean titer (95% confidence interval) observed against the 2017 A(H7N9) strain was 133.4 (83.6–212.6) among participants who received homologous, adjuvanted 3.75 µg + AS03/2017 doses with delayed boost interval. Conclusions Administering AS03 adjuvant with the second H7N9 IIV dose and extending the boost interval to 4 months resulted in higher peak antibody responses. These observations can broadly inform strategic approaches for pandemic preparedness. Clinical Trials Registration. NCT03589807. [ABSTRACT FROM AUTHOR]

Purpose To improve adolescent immunization coverage in a rural North Carolina county. Methods Adolescent immunization coverage rates in an intervention and four comparison counties were compared over 1 year. We introduced practice-based interventions in seven practices centering on immunization registry-driven recall of adolescents for immunizations with postcard reminders (Phase 1), and 6 months later employed nontargeted school-generated telephone reminders to parents of adolescents (Phase 2). Results Improvements in the intervention county among 11- to 12-year-olds occurred for first-dose human papillomavirus vaccine in both boys (overall change, 14.2%–32.1%) and girls (27.4%–43.4%) and the meningococcal vaccine (34.6%–49.4%). Improvements among adolescents 13–18 years were limited to human papillomavirus vaccine completion in boys (1.6%–4.2%). Improvements were greater during Phase 1 than Phase 2 and among younger adolescents. Coverage improvements in the comparison counties were smaller than those observed in the intervention county. Conclusions A resource-light two-phase intervention led to modest improvements in immunization coverage, most notably in the largest adolescent practice in the county, and suggested potential for further gains, particularly among younger adolescents. [ABSTRACT FROM AUTHOR]

BACKGROUND AND OBJECTIVES: Postvaccination syncope can cause injury. Drinking water prephlebotomy increases peripheral vascular tone, decreasing risk of blood-donation presyncope and syncope. This study evaluated whether drinking water prevaccination reduces postvaccination presyncope, a potential syncope precursor. METHODS: We conducted a randomized trial of subjects aged 11 to 21 years receiving ≥1 intramuscular vaccine in primary care clinics. Intervention subjects were encouraged to drink 500 mL of water, with vaccination recommended 10 to 60 minutes later. Control subjects received usual care. Presyncope symptoms were assessed with a 12-item survey during the 20-minutes postvaccination. Symptoms were classified with a primary cutoff sensitive for presyncope, and a secondary, more restrictive cutoff requiring greater symptoms. Results were adjusted for clustering by recruitment center. RESULTS: There were 906 subjects randomly assigned to the control group and 901 subjects randomly assigned to the intervention group. None had syncope. Presyncope occurred in 36.2% of subjects by using the primary definition, and in 8.0% of subjects by using the restrictive definition. There were no significant differences in presyncope by intervention group for the primary (1-sided test, P = .24) or restrictive outcome (1-sided test, P = .17). Among intervention subjects vaccinated within 10 to 60 minutes after drinking all 500 mL of water (n = 519), no reduction in presyncope was observed for the primary or restrictive outcome (1-sided tests, P = .13, P = .17). In multivariable regression analysis, presyncope was associated with younger age, history of passing out or nearly passing out after a shot or blood draw, prevaccination anxiety, receiving >1 injected vaccine, and greater postvaccination pain. CONCLUSIONS: Drinking water before vaccination did not prevent postvaccination presyncope. Predictors of postvaccination presyncope suggest opportunities for presyncope and syncope prevention interventions. [ABSTRACT FROM AUTHOR]

• Southern adolescents have the lowest HPV vaccination coverage in the US. • HPV vaccination reported in 37.3% of adolescents, with highest initiation at 12 years. • Compared with other adolescent vaccinations, uptake of HPV vaccination is lower. • Strengthening provider recommendation may improve on-time HPV vaccination. Despite a high burden of human papillomavirus (HPV)-attributable cancers, the southern US lags other regions in HPV vaccination coverage. This study sought to characterize and contextualize predictors of HPV vaccination in the southern US. From December 2019 – January 2020, parents of adolescents (ages 9–17 years) living in thirteen southern US states were recruited from a nationally-representative online survey panel and completed a cross-sectional survey. The primary study outcome was initiation of HPV vaccination. Of 1105 parents who responded to the survey, most were ≥35 years of age and of female gender. HPV vaccination initiation was reported only among 37.3% of adolescents and was highest at age 12. Cumulative HPV vaccination coverage was highest at age 15 (60%) but lower than coverage for tetanus-diphtheria-acellular pertussis (Tdap, 79.3%) and Meningococcal vaccines (MenACWY, 67.3%). Provider recommendation was strongly associated with higher odds of HPV vaccination (aOR: 49.9, 95 %CI: 23.1–107.5). In alternative predictive models, home/online (vs. public) schooling and parents' working status were associated with lower odds of vaccination; health care visits in the past 12 months and shorter travel times to adolescents' usual health care provider were associated with greater odds of vaccination. Our findings suggest missed opportunities for HPV vaccination in the southern US and support strengthening provider recommendation for on-time initiation of HPV vaccination among adolescents. Other strategies to increase HPV vaccinations may include encouraging co-administration with other adolescent vaccines, increasing vaccine access, and promoting vaccinations for home/online-school students. [ABSTRACT FROM AUTHOR]

In the article, the authors present recommendations to facilitate the development, testing and approval of vaccines for children. Other topics include the increased pediatric hospital admissions for coronavirus disease 2019 (COVID-19) in the U.S., the trials conducted by Moderna and Pfizer/BioNTech on the safety and efficacy of their messenger RNA (mRNA) vaccines to children and adolescents, as well as the tips like the use of preclinical pediatric animal models.

BACKGROUND AND OBJECTIVES: Although both licensed rotavirus vaccines are safe and effective, it is often not possible to complete the schedule by using the same vaccine formulation. The goal of this study was to investigate the noninferiority of the immune responses to the 2 licensed rotavirus vaccines when administered as a mixed schedule compared with administering a single vaccine formulation alone. methods: Randomized, multicenter, open-label study. Healthy infants (6-14 weeks of age) were randomized to receive rotavirus vaccines in 1 of 5 different schedules (2 using a single vaccine for all doses, and 3 using mixed schedules). The group receiving only the monovalent rotavirus vaccine received 2 doses of vaccine and the other 4 groups received 3 doses of vaccine. Serum for immunogenicity testing was obtained 1 month after the last vaccine dose and the proportion of seropositive children (rotavirus immunoglobulin A ≥20 U/mL) were compared in all the vaccine groups. RESULTS: Between March 2011 and September 2013,1393 children were enrolled and randomized. Immune responses to all the sequential mixed vaccine schedules were shown to be noninferior when compared with the 2 single vaccine reference groups. The proportion of children seropositive to at least 1 vaccine antigen at 1 month after vaccination ranged from 77% to 96%, and was not significantly different among all the study groups. All schedules were well tolerated. CONCLUSIONS: Mixed schedules are safe and induced comparable immune responses when compared with the licensed rotavirus vaccines given alone. [ABSTRACT FROM AUTHOR]

Abstract: The aims of this study were to determine the percentage of females who after initiating the human papillomavirus (HPV) vaccine series, both completed it and completed it on-time, as well as to examine factors associated with series completion and on-time completion. Using data from the North Carolina Immunization Registry, of 138,823 females analyzed, 55% completed the series, and 28% completed it on-time. Over 83% of those who initiated the vaccine series in 2006 completed it by the final study date, as compared to 32% of those who initiated the vaccine in 2009. On-time dosing rates, however, are declining, and have been hovering at 25% for the last two years of the study. Factors such as African-American race and public funding were significantly associated with lower rates of on-time dosing as well as series completion when compared to White race and private funding, respectively. Among girls and young women who initiate the HPV vaccination series, overall completion rates are low, but if given enough time most of those who begin the series will complete it. Our results suggest that strategies to improve the timely completion of the HPV vaccination series may be needed. [Copyright &y& Elsevier]