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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.

Recent research has highlighted the need for a deeper understanding of the heterogeneity in trajectories of children's distress following acute pain exposure, moving beyond group means of behavioural pain scores at a single timepoint. During preschool vaccinations, three distinct trajectories of post-vaccination pain regulation have been elucidated, with approximately 75% of children displaying trajectories characterized by down-regulation to no distress by two minutes post-needle and 25% concerningly failing to down-regulate by two-minutes. The objective of the present study was to examine child and caregiver predictors of preschool children's post-vaccination regulatory patterns. Our results indicated that higher child baseline distress, more caregiver coping-promoting verbalizations in the first minute following the needle, less coping -promoting verbalizations in the second minute, and more caregiver distress-promoting verbalizations in the second minute following the needle were associated with membership in the trajectories characterized by high distress. Further, while all children's pain-related distress at various timepoints throughout the appointment was most strongly predicted by prior pain scores, different patterns of associations emerged depending on the trajectory exhibited. This research highlights both the need to minimize distress prior to the needle in order to avoid the highly distressed trajectory as well as the importance of considering the heterogeneity of trajectories of preschool pain responding when examining the factors that are associated with children's pain-related distress.

There is considerable variability regarding the convergence between behavioral and biological aspects of distress responses in toddlerhood, and little research has investigated the convergence of these measures in high distress. The aim of the current study was to describe patterns of distress responses to vaccinations as indexed by both pain-related behavioral distress and heart rate (HR) at 12 and 18 months. Caregiver-toddler dyads were part of an ongoing longitudinal cohort observed during 12- (N = 158) and 18-month (N = 122) well-baby vaccinations. Parallel-process growth mixture models discerned two distinct groups at 12 months and three distinct groups at 18 months. All groups had comparable pain-related behavioral distress and HR responses post-vaccination, with most participants displaying high arousal and regulation to baseline levels following the vaccination. However, at 18 months, an important minority had a blunted response or did not regulate to a low level of distress by 3 min post-needle. Post hoc analyses revealed that higher baseline pain-related behavioral distress predicted membership in the majority groups at 12 and 18 months. These results highlight the developmental differences and variability in behavioral and cardiac indicators of distress regulation across the second year of life.

This article consists of 2 separate studies in which the overarching aim was to examine the relationships between caregiver-child behaviours in the vaccination context (infant and preschool) and preschool attachment outcomes. It provides for the first time an examination of acute pain behaviours during early childhood and how it relates to a critical aspect of child development (ie, attachment status) at the end of early childhood. Study 1 examined the longitudinal relationships between caregiver-infant behaviours during infants' first routine vaccination (2 months) and preschool attachment (n = 84). Study 2 examined the concurrent relationships between caregiver-preschooler behaviours during the last routine vaccination of preschool (4-5 years) and preschool attachment (n = 117). Hierarchical multiple regression analyses were used. Although there were several nonsignificant findings, the results revealed that higher caregiver sensitivity and higher proximal soothing 1 minute before the needle during infants' 2-month vaccinations predicted higher levels of preschooler avoidance and lower levels of preschooler ambivalence, respectively. In addition, higher infant pain-related distress at 2 minutes after the needle was related to higher preschooler security and lower preschooler disorganization and controlling-punitive attachments. In terms of concurrent relationships, only caregiver sensitivity was significantly related to preschool attachment outcomes. Specifically, higher caregiver sensitivity at preschoolers' 4- to 5-year vaccinations was related to higher preschooler attachment security. The study findings provide evidence that child-caregiver behavioural patterns during the infant and preschool routine vaccination relate to preschoolers' patterns of attachment. Moreover, it underscores the potential importance of health professionals teaching and supporting attuned caregiving to the child in pain.

The aim of this study was to examine the concurrent and predictive relations between healthy toddlers' pain behavior and cardiac indicators (ie, heart rate [HR] and respiratory sinus arrhythmia [RSA]) during routine vaccinations. Caregiver-infant dyads were part of a longitudinal cohort observed during their 12- and 18-month vaccinations. Behavioral and cardiac data were simultaneously collected for 1-minute preneedle and 3-minutes postneedle. Videotapes were coded for pain behaviors (FLACC; Merkel et al., 1997), and cardiac data were analyzed (HR, RSA) during sequential 30-second epochs. Four separate cross-lagged path models were estimated using data from the 12- (n = 147) and 18-month (n = 122) vaccinations. Across 12- and 18-month vaccinations, predictive within-measure relations were consistent for FLACC, HR, and RSA, reflecting good stability of these pain indicators. Behavioral indicators predicted subsequent HR and RSA within the immediate postneedle period. Both baseline behavior and HR/RSA predicted future pain scores. Concurrent residual relations between behavioral and cardiac indicators were inconsistent across time and indicators. Results suggest that behavioral and cardiac indicators reflect unique aspects of the nociceptive response. As such, multimodal assessment tools should be used and contextualized by child age, cardiac indicator, baseline behavior/physiology, and pain phase.

Objective The current study sets out to conduct a post hoc analysis of the moderating effect of parent psychological distress on a pediatric pain management intervention. Methods Parents of 6-month-old infants (n = 64) and 18-month-old toddlers (n = 64 each) were randomized to a treatment (The ABCDs of Pain Management) or control video and videotaped during the vaccination. Parent psychological distress was also measured at the vaccination. Outcomes were children's pain, parent worry, and parent soothing behavior post-vaccination. Results Parent psychological distress only moderated video effect on toddler pain during the regulation phase. Parent psychological distress did not moderate the impact of the video on parent worry or parent soothing post-needle at either age. The video did increase parent soothing in parents of both infants and toddlers, and reduced worry in parents of toddlers. Conclusions To our knowledge, this is the first study to assess a moderating factor on a child pain management intervention. The video's efficacy was moderated for toddlers' pain regulation, such that parents with high psychological distress did not show as much benefit from the intervention. No other moderations were found in either age group for any other outcome. Main effects for the video impacting soothing behavior of parents of both infants and toddlers were confirmed, and a new finding of video efficacy was seen through the significantly lower worry of toddlers' parents post-needle. Given the nonclinical sample, low levels of psychological distress were found. Efforts to replicate this study in a higher risk sample are necessary.

Objectives To test the efficacy of a brief behavioral pain management strategy (The ABCDs of Needle Pain Management), delivered via video, on infants' and toddlers' pain scores and on parental soothing behavior. Methods This was a double-blind, parallel trial design. Parent-child dyads (N = 128) were recruited before their child's 6-month (infant) or 18-month (toddler) vaccination in a pediatric clinic and randomly assigned to watch a 5-min treatment video or a placebo video. The primary outcome was the Modified Behavior Pain Scale (Taddio et al., Journal of Pain and Symptom Management, 10, pp. 456-463, 1995), coded during four epochs (Pain Reactivity, Pain Regulation 1 min, Pain Regulation 2 min, and Pain Regulation 3 min) after the last vaccination needle. Secondary analyses examined parental use of distraction, rocking, and physical comforting over this same time period. Results Results demonstrated a treatment effect for toddlers (18-month-olds) for the Pain Regulation 1 (d = 0.84) and Pain Regulation 2 (d = 0.76) postvaccination scores. Secondary analyses found differences in parental rocking and physical comforting between treatment conditions and between age-groups (d's = 0.37-0.54). Conclusions The ABCD pain management strategy delivered via video was an effective way to reduce toddler pain after vaccination and increase parental use of rocking and physical comforting. The treatment effect was not demonstrated with infants.

The current study sets forth to provide descriptive data for preschool vaccination pain responding as well as examine longitudinal relationships over early childhood. Growth mixture modeling was first used to describe stable subgroups of preschoolers on the basis of their pain response patterns over 2-minutes post-needle. Secondly, a parallel-process growth curve model was used to assess the stability of acute pain responding from 12 months of age to preschool age. Specifically, we examined whether preschool pain-related distress or regulation could be predicted from 12-month acute pain responding. Preschool participants were part of a Canadian longitudinal cohort (The Opportunities to Understand Childhood Hurt [OUCH] cohort; N = 302). Growth mixture modeling analyses discerned 3 distinct groups of preschoolers, with an important minority not regulating to low-no pain by 2 minutes post-needle. There were no significant associations between 12-month and preschool pain responding. These results highlight the steep trajectory of development between these different stages of early childhood and the variability of pain responding at the preschool vaccination. Perspective This study provides descriptive data for preschool vaccination pain responding as well as examines longitudinal relationships over early childhood. Demonstrating significantly different pain patterns from infancy, 25% of preschoolers are displaying suboptimal regulation trajectories. This considerable minority poses a significant concern because of the established trajectory of phobia onset in middle childhood.

OBJECTIVE The objective of this study was to determine which variables predict parental postvaccination pain ratings. It was hypothesized that after child behavior, parental sensitivity, and parental reports of worry would be the strongest predictors. METHODS Data for 215 parent-child dyads were analyzed from a longitudinal cohort at the preschool (4 to 5 y of age) vaccination. Preschoolers' pain behaviors 15 seconds, 1 minute 15 seconds, and 2 minutes 15 seconds after the painful immunization were observed and rated. Parental sensitivity, as well as parental own worry and their assessment of their child's worry, were assessed before and after the needle. Three regression models were used to determine the impact of these variables on parental pain assessment. RESULTS Preschoolers' pain behaviors moderately accounted for variance in parental pain judgment (R=0.23 to 0.28). Parental sensitivity was not a significant unique predictor of parental pain rating at the preschool age. Parental assessment of their own worry and worry about their preschoolers after the needle were critical contributors to parental pain judgment. Post hoc analyses suggest that parents who report low child worry, are more congruent with their child during regulatory phases postvaccination. However, both parents with high and low self-worry had more congruent pain ratings with child pain behavior scores during the reactivity phase. DISCUSSION The study suggests that the majority of variance in parent pain ratings was not predominantly based on preschoolers' pain behaviors. Parental worry levels and their assessment of their child's worry were also significant predictors. Clinical implications are discussed.

Anticipatory distress prior to a painful medical procedure can lead to negative sequelae including heightened pain experiences, avoidance of future medical procedures, and potential noncompliance with preventative health care, such as vaccinations. Few studies have examined the longitudinal and concurrent predictors of pain-related anticipatory distress. This article consists of 2 companion studies to examine both the longitudinal factors from infancy as well as concurrent factors from preschool that predict pain-related anticipatory distress at the preschool age. Study 1 examined how well preschool pain-related anticipatory distress was predicted by infant pain response at 2, 4, 6, and 12 months of age. In study 2, using a developmental psychopathology framework, longitudinal analyses examined the predisposing, precipitating, perpetuating, and present factors that led to the development of anticipatory distress during routine preschool vaccinations. A sample of 202 caregiver-child dyads was observed during their infant and preschool vaccinations (the Opportunities to Understand Childhood Hurt cohort) and was used for both studies. In study 1, pain response during infancy was not found to significantly predict pain-related anticipatory distress at preschool. In study 2, a strong explanatory model was created whereby 40% of the variance in preschool anticipatory distress was explained. Parental behaviours from infancy and preschool were the strongest predictors of child anticipatory distress at preschool. Child age positively predicted child anticipatory distress. This strongly suggests that the involvement of parents in pain management interventions during immunization is one of the most critical factors in predicting anticipatory distress to the preschool vaccination.

The quadrivalent meningococcal glycoconjugate vaccine MenACWY-CRM is licensed for children from 2 months of age as a 4-dose series. This study assessed the immunogenicity of a 3-dose MenACWY-CRM vaccination series in infants, compared with the 4-dose series, and evaluated the impact of MenACWY-CRM concomitant administration on immune responses to the 13-valent pneumococcal conjugate vaccine (PCV13).Overall, 751 healthy infants (age: 55-89 days) were randomized to receive 3 or 4 doses of MenACWY-CRM (2/4/12 or 2/4/6/12 months of age, respectively) with PCV13 + routine vaccinations (ACWY3 and ACWY4 groups, respectively) or PCV13 + routine vaccinations only (routine group). Immunological noninferiority of the 3-dose versus 4-dose MenACWY-CRM vaccination series was evaluated at 13 months of age for serogroups CWY; noninferiority of immune responses to PCV13 serotypes for concomitant administration of MenACWY-CRM and PCV13 was evaluated at 7 and 13 months of age.At 13 months, 88%-100% of subjects in groups ACWY3 and ACWY4 achieved seroprotective bactericidal antibody titers against serogroups ACWY; noninferiority criteria for the 3-dose versus 4-dose MenACWY-CRM vaccination series were met. At 7 months, noninferiority criteria were met for all PCV13 serotypes except for serotypes 3 and 5 (group ACWY3) and 19A (group ACWY4). At 13 months, noninferiority criteria were met for all PCV13 serotypes for both ACWY groups.After completion of either MenACWY-CRM vaccination series, most subjects achieved seroprotective titers against serogroups ACWY, with the 3-dose series being noninferior to the 4-dose series for serogroups CWY, and no interference with immune responses against PCV13 serotypes was observed (NCT01214837).

Background Data on duration of protection against invasive meningococcal disease post-vaccination with the recombinant, 4-component, meningococcal serogroup B vaccine (4CMenB) are limited. We evaluated bactericidal activity persistence in adolescents/young adults up to 7.5 years post-primary vaccination with 4CMenB, and response to a booster dose compared with vaccine-naive controls. Methods This open-label, multicenter study (NCT02446743) enrolled 15–24 year-old-previously vaccinated participants from Canada, Australia (group Primed_4y) 4 years post-priming with 4CMenB (2 doses; 0,1-month schedule), and Chile (Primed_7.5y) 7.5 years after priming with 4CMenB (2 doses; 0,1/0,2/0,6-month schedule) and vaccine-naive participants of similar age (Naive_4y and Naive_7.5y groups). Primed participants received a booster dose; vaccine-naive participants received 2 catch-up doses of 4CMenB, 1 month apart. We evaluated antibody persistence and immune responses using hSBA in terms of geometric mean titers and percentages of participants with hSBA titers ≥4, the kinetics of bactericidal activity post-booster (previously vaccinated) or post-2 doses (vaccine-naive), and safety. Results Antibody levels declined at 4 (Primed_4y) and 7.5 (Primed_7.5y) years post-primary vaccination, but remained higher than in vaccine-naive participants at baseline (≤44% vs ≤ 13% [fHbp]; ≤84% vs ≤ 24% [NadA]; ≤29% vs ≤ 14% [PorA]) for all vaccine antigens except NHBA (≤81% vs ≤ 79%). One month post-booster and post-second dose, 93–100% of primed and 79–100% of vaccine-naive participants had hSBA titers ≥4 for all antigens. Kinetics of the antibody response were similar across groups with an early robust response observed 7 days post-booster/second dose. No vaccine-related serious adverse event was reported. Conclusion For all antigens except NHBA, a higher proportion of primed participants had hSBA titers ≥4, at 4 and 7.5 years post-vaccination, compared with vaccine-naive participants. A more robust immune response after booster compared to a first dose in vaccine-naive individuals, showed effective priming in an adolescent/young adult population. No safety or new reactogenicity issues were identified. An Audio Summary linked to this article that can be found on Figshare: https://figshare.com/articles/Antibody_persistence_and_booster_response_in_adolescents_and_young_adults_4_and_7_5_years_after_immunization_with_4CMenB_vaccine/9437276 ; https://doi.org/10.6084/m9.figshare.9437276.v1 .

Parents play a critical role in supporting infants&rsquo, ability to manage strong emotions. Routine vaccinations provide an ideal context to observe the effect of parents&rsquo, behaviors on infants&rsquo, pain-related distress. Previous research in the vaccination context showed that parent sensitivity, operationalized by variables such as emotional availability and proximal soothing behaviors, is associated with infant pain-related distress behavior. However, the magnitudes of these relationships were smaller than expected given the established importance of parents in the development of distress regulation. In recent work, a reliable and valid measure to operationalize insensitive behaviors was developed. The objective of the current study was to examine the relative contribution of variables representing sensitive and insensitive behaviors to the prediction of infant pain-related distress behaviors during the reactivity and regulation phases of needle pain. Archival data was used to analyze a subsample of infants followed during their two-month, six-month, and 12-month vaccinations (n = 81). Results of regression analyses indicated that parent insensitive behaviors generally had the strongest relationships with pain outcomes across all ages, with a greater influence on regulation-phase pain-related distress behavior, rather than reactivity-phase pain-related distress behavior. Our findings support the utility of a measure of distress-promoting parent behaviors in a vaccination context, and highlight the potential value of this measure for clinicians and researchers.

Although previous research has examined the relationships between caregiver proximal soothing and infant pain, there is a paucity of work taking infant age into account, despite the steep developmental trajectory that occurs across the infancy period. Moreover, no studies have differentially examined the relationships between caregiver proximal soothing and initial infant pain reactivity and pain regulation. This study examined how much variance in pain reactivity and pain regulation was accounted for by caregiver proximal soothing at 4 routine immunizations (2, 4, 6, and 12 months) across the first year of life, controlling for preneedle distress. One latent growth model was replicated at each of the 4 infant ages, using a sample of 760 caregiver-infant dyads followed longitudinally. Controlling for preneedle infant distress, caregiver proximal soothing accounted for little to no variance in infant pain reactivity or regulation at all 4 ages. Preneedle distress and pain reactivity accounted for the largest amount of variance in pain regulation, with this increasing after 2 months. It was concluded that within each immunization appointment across the first year of life, earlier infant pain behaviour is a stronger predictor of subsequent infant pain behaviour than caregiver proximal soothing. Given the longer-term benefits that have been demonstrated for proximal soothing during distressing contexts, caregivers are still encouraged to use proximal soothing during infant immunizations.

BACKGROUND: There is considerable variability in infants’ responses to painful stimuli, including facial and vocal expressions. This variability in pain-related distress response may be an indicator of temperament styles in childhood.OBJECTIVE: To examine the relationships among immunization pain outcomes (pain reactivity, pain regulation and parent ratings of infant pain) over the first year of life and parent report of early temperament.METHODS: A subset of parent-infant dyads in an ongoing Canadian longitudinal cohort was studied. Infant pain behaviours were coded using the Modified Behavior Pain Scale. Parental judgments of infant pain were recorded using the Numeric Rating Scale. Infant temperament was measured using the Infant Behaviour Questionnaire-Revised. Correlational analyses and multiple regressions were conducted.RESULTS: Multiple regressions revealed that the 12-month regulatory pain scores predicted parent ratings of the Negative Affectivity temperament dimension at 14 months of age. Parent ratings of infant pain at 12 months of age predicted parent ratings of the Orienting/Affiliation temperament dimension, with sex differences observed in this substrate.CONCLUSION: Pain-related distress regulation at one year of age appears to be a novel indicator of parent report of temperament ratings. Pain outcomes in the first six months of life were not related to parent temperament ratings.

Objective This study investigated the associations between caregiver verbal reassurance and infant pain-related distress during immunization over the first year of life. The relationships between verbal reassurance and caregiver emotional availability (EA) were also examined. Finally, EA was investigated as a moderator of the relationship between verbal reassurance and infant pain. Methods A cross-sectional analysis was conducted with 606 infants (and their parents) at 4 different ages (n ¼376 at 2 months, n ¼455 at 4 months, n ¼484 at 6 months, and n ¼407 at 12 months). Results Verbal reassurance was positively associated with infant distress across all four ages. EA was only negatively related to verbal reassurance at 12 months of age. EA was not a significant moderator at any age. Conclusion Findings demonstrate consistent but small relationships between verbal reassurance and infant pain over the first year of life.

An estimated 5%–15% of the world's population experiences an influenza virus infection each year [1], with an estimated 90 million cases occurring in children [2]. Significant complications of influenza are most likely to occur in persons with underlying medical conditions, the elderly, and children, especially those aged 30 years ago. The dose of influenza antigen is known to play an important role in influenza vaccine immunogenicity, but little data are available on the relative safety and immunogenicity of a full (adult) dose (0.50 mL) compared with a half dose (0.25 mL) of TIV in children aged

Recent research has begun to examine discrete caregiver pain management behaviors in the infant immunization context. However, there is a dearth of research exploring more global caregiving constructs, such as emotional availability, which can be used to examine the overall sensitivity of caregiver pain management. The aim of the present study was to examine the relationships between caregiver sensitivity (emotional availability) and infant pain behavior (baseline, immediately post-needle, 1 min after needle) over the first year of life. Parents and infants were a part of a Canadian longitudinal cohort (the Opportunities to Understand Childhood Hurt or OUCH cohort) followed up during their 2-, 4-, 6-, and 12-month immunizations (current n = 731). Both within-age group analyses and over-age analyses were performed. Results indicated that: (1) over age, previous infant pain behavior predicts future infant pain behavior, but this varied depending on timing of pain response and age of infant; (2) over age, previous caregiver sensitivity strongly predicts future caregiver sensitivity; and (3) the concurrent relationship between caregiver sensitivity and every type of infant pain response is only consistently seen at the 12-month immunization. Caregiver sensitivity to the infant in pain is predicted most reliably from previous caregiver sensitivity, not infant pain behaviour. The significant concurrent relationship between caregiver sensitivity and infant pain behaviours is not seen until 12 months, replicating patterns in the infant development literature regarding the time at which the attachment relationship between parent and child can be reliably measured. Discussion addresses implications for both researchers and clinicians who work with infants in pain.

Background Seasonal vaccination against influenza is the most important public health strategy to prevent influenza morbidity and mortality in children 6–23 months of age. However, influenza immunization uptake in this population remains sub-optimal. While parents look to healthcare professionals (HCPs) for guidance, HCPs may be neither aware of the burden of influenza disease in infants nor familiar with ways to address parental influenza vaccine hesitancy. The objective of this research was to describe the impact of an Information—Motivation—Behavioral Skills model (IMB)-based, accredited, online Continuing Medical Education (CME) program on seasonal influenza vaccination in children 6–23 months of age in Ontario, Canada during the 2016/2017 influenza season. Methods A multi-center, randomized, controlled trial was conducted whereby HCPs were randomized to either an accredited IMB-based CME or to routine practice (no CME). The CME addressed influenza burden in young children and identified parental barriers (hesitancy) to influenza vaccination, designed to inform, motivate, and upskill HCPs. All vaccine options were reviewed, including the adjuvanted, trivalent, inactive, influenza vaccine (aTIV). Immunization rates were compared between groups using Pearson’s chi-squared and a logistic regression model adjusting for socioeconomic status at the clinic-level. Results A total of 68 HCPs were recruited: 33 randomized to the CME group and 35 to routine practice. HCP interactions with parents were evaluated during 628 visits: 292 visits by HCPs in the CME group and 336 by HCPs in the routine practice group. Parents seen by HCPs in the CME group were ~30% more likely to agree to immunize their child with seasonal influenza vaccination compared with parents seen by HCPs in the control group (P = 0.007). The adjusted odds of influenza immunization were 1.5 times higher in the CME group compared with the control group. Children in the CME group were ~20% more likely to receive aTIV compared with children in the control group (P < 0.001). Conclusion HCP education with a tailored health behavior uptake model based CME addressing the burden of influenza disease in young children and influenza vaccine hesitancy was associated with a significant increase in influenza immunization. Disclosures W. Fisher, Seqirus: Consultant and Investigator, Consulting fee and Speaker honorarium. J. Yaremko, Seqirus: Collaborator and Investigator, Speaker honorarium. V. Brown, Seqirus: Investigator, Speaker honorarium. H. Garfield, Seqirus: Investigator, Speaker honorarium. E. Rampakakis, Seqirus: Independent Contractor, Consulting fee. C. Boikos, Seqirus: Employee, Salary. J. A. Mansi, Seqirus: Employee and Shareholder, Salary.

Background 4CMenB has been shown to be immunogenic with an acceptable safety profile in infants and young adolescents. However, no data on long-term persistence after primary vaccination in adolescents are available. This is the first study to assess antibody persistence, booster response, and safety of 4CMenB in adolescents and young adults up to 7.5 years following the primary vaccination in adolescence. Methods This phase 3b, open-label, extension study (NCT02446743) assessed the antibody persistence and booster response at 4 years (Canada and Australia, NCT01423084) or 7.5 years (Chile, NCT00661713) after primary vaccination with 4CMenB (following 0 + 1-, 0 + 2-, or 0 + 6-month schedules), compared with vaccine-naïve (VN), healthy controls. Chilean follow-on (FO) and VN participants aged 18–24 years received either a booster dose of 4CMenB 7.5 years postprimary series (Group FO, N = 131) or 2 primary doses, 1 month apart (Group VN, N = 150). Immunogenicity was measured using human serum bactericidal antibody assay (hSBA) against antigen-specific strains. Immune response was evaluated 1 month post-booster vaccination and compared with VN controls at 1 month post-first dose. Kinetics of antibody responses were measured at 3, 7, and 30 days post-vaccination. Safety was assessed. Results Antibody levels waned at 7.5 years postprimary vaccination in Group FO, but were higher than in Group VN at baseline, for all antigens except NHBA (table). At 1 month post-booster/post-first dose, 93–100% (Group FO) and 62–93% (Group VN) of participants had hSBA titres ≥4; GMTs ranged between 41 and 1,951 (Group FO) and 9.43–46 (Group VN) (table). The percentages of FO participants with hSBA titres ≥4 remained similar to prebooster for all 4 antigens at 3 days, increased at 7 days, and remained unchanged or increased further 30 days post-booster. The reactogenicity of 4CMenB was consistent with previous observations in this age group; no safety concerns were identified during the study. Conclusion Antibody levels in adolescents and young adults declined at 7.5 years after a 2-dose primary series of 4CMenB, but were higher than baseline levels in VN controls. An additional dose of 4CMenB elicited strong anamnestic responses—substantially higher than 1 dose in VN controls. Funding: GlaxoSmithKline Biologicals SA. Disclosures T. Nolan, GSK: Research Contractor and Scientific Advisor, Research grant. Pfizer: Research Contractor, Research grant. M. O’Ryan, GSK: Investigator, Research support. F. De Looze, GSK: Investigator and Research Contractor, Research grant and Research support. H. Marshall, Pfizer: Grant Investigator and Investigator, Research grant. GSK: Grant Investigator and Investigator, Research grant. P. Richmond, GSK: Grant Investigator and Scientific Advisor, Grant recipient. S. Henein, SKDS Research Inc.: Investigator, Research payment. K. Heaton, Devonshire Clinical Research Inc.: Investigator, Research payment. M. Ferguson, GSK: Investigator, Salary from independent research clinic,CRG. D. D’Agostino, GSK: Employee, Salary. D. Toneatto, GSK: Employee and Shareholder, Salary.

Background: Medical student rotations in community practice settings are increasingly common within pediatric clerkship curricula yet little evidence exists to support the quality of the educational exposure. Purpose: To assess the impact of clerkship site (community setting vs. exposure to an Academic Health Sciences Center) on the following educational outcomes: 1. Clinical Performance; 2. Examination Performance; 3. Written Assignment Performance; and 4. Successful Matching to a Canadian Pediatric Residency Program. Methods: 340 medical students from the graduating classes of 2007 and 2008 at the University of Toronto, Canada were studied. Rotation performance (clinical assessment, examination mark, and written assignment mark) and acceptance into a Canadian pediatric residency program were assessed in relation to clerkship rotation site. These outcomes were assessed while controlling for the following potential confounders: 1) Pre-clerkship career preference and 2) Pre-rotation site preference as expressed by each medical student. Results: 172 medical students completed rotations that included exposure to an academic health sciences center, while 168 medical students had exclusive exposure to the community setting. Students who completed exclusively community-based pediatric rotations received slightly higher clinical evaluations (p=0.006), but not exam marks (p=0.812) nor written assignment marks (p=0.086). Students who had expressed an interest in paediatrics as a career prior to beginning their clerkship performed better during paediatric clerkship regardless of site (p= .0003) and were more likely to choose a clerkship setting that included exposure to an Academic Health Sciences Center (p=.052). Clerkship setting was not found to impact on successful matching to a Canadian pediatric residency program (p=0.171). Discussion: These results help support the decision of curriculum committees to incorporate the use of community practice settings and inform students and faculty as to the validity of distributed medical education within the field of pediatric medical education.

Social and emotional competencies, such as distress regulation, are established in early childhood and are critical for the development of children’s mental health and wellbeing. Routine vaccinations in primary care provide a unique opportunity to relate responses to a universal, relatively standardized, distress regulation paradigm (i.e., pain-related distress) to key developmental outcomes. The current study sought to examine distress regulation during routine vaccination in infancy and preschool as predictors of outcomes related to socioemotional competence in preschool. It was hypothesized that children with poorer distress regulation abilities post-vaccination would have lower socioemotional development. Furthermore, it was hypothesized that insensitive parenting would exacerbate this relationship for children with poor distress regulation abilities. As part of an ongoing longitudinal cohort, 172 parent–child dyads were videotaped during vaccinations in infancy and preschool, and subsequently participated in a full-day psychological assessment in a university lab. Videotapes were coded for child pre-needle distress (baseline distress), immediate post-needle pain-related distress reactivity (immediate distress reactivity), and pain-related distress regulation (distress regulation). Parent sensitivity during the preschool vaccination was also coded. Baseline distress prior to vaccination predicted greater externalizing problems and behavioral symptoms. Parent sensitivity did not moderate the association between any child distress behaviors and socioemotional development indicators. Child distress behaviors prior to injection, regardless of parent behavior, during the vaccination context may provide valuable information to health care professionals about child socioemotional functioning in the behavioral and emotional domains.

This study aimed to understand the relationship between caregiver culture and infant pain expression at the 12-month immunization and discern if a mechanism subsuming this relationship was the quality of caregiver behaviors (emotional availability). Infants (N = 393) with immunization data at 12 months of age were examined. On the basis of the Development of Infant Acute Pain Responding model, a mediation model was developed to examine how caregiver behaviors mediate the relationship between caregiver heritage culture and infant pain. Culture was operationalized by an objectively derived quantification of caregivers' self-reported heritage culture's individualism. Two mediation models were estimated, examining infant pain expression at 1 and 2 minutes post-needle. Caregivers who self-reported heritage cultures that were more highly individualistic tended to show greater emotional availability, which in turn predicted decreased infant pain expression at 1 and 2 minutes post-needle. The present findings further our understanding of one mechanism by which caregiver culture affects infant acute pain expression. Perspective Adding to the literature examining direct relationships between culture and infant immunization pain, this article proposes the quality of caregiver behaviors as a mechanism by which culture affects infant acute pain expression at 12 months of age. Results support the proposed mechanism and inform our understanding of the role of caregiver culture in the infant pain context.

Objectives There were 2 primary objectives to the current study: (1) to relate caregiver behavior trajectories across immunization appointments over the first year of life to subsequent infant attachment and (2) to relate caregiver behavior trajectories within each immunization appointment over the first year of life to subsequent infant attachment. Method A subsample of 130 caregivers and their infants were recruited from a sample of 760 caregivers who were part of an ongoing longitudinal cohort that videotaped infants' 2-, 4-, 6-, and 12-month immunization appointments. This subsample of caregivers and their infants (n = 130) were invited to participate in an assessment of attachment when infants were between 12 and 18 months of age at the local children's hospital. Results Caregiver proximal soothing behaviors were the only caregiver behaviors postimmunization that were related to subsequent infant attachment. Higher frequencies of caregiver proximal soothing at 12 months were related to infants' organized attachment, whereas steeper decreases in proximal soothing across the first year were associated with disorganized infant attachment. In addition, when caregivers engaged in proximal soothing for longer after their 12 month olds' immunizations, these infants were more likely to be secure or organized in their attachment. Conclusion These results provide empirical support for the ecological validity of studying infant attachment in a pediatric pain context. The pediatric "well-baby" visit may provide a potential opportunity to feasibly integrate brief infant mental health screening and intervention.

Ideally, medical care for children should be accessible, continuous and comprehensive (1). However, it has been found that physicians’ after-hours availability varies markedly among four Canadian cities, from a low of 27% to a high of 92% (2). Thus, parents must frequently seek care for their acutely ill child in alternate settings. Paediatric after-hours clinics have developed in many urban centres to provide after-hours care to children with common acute illnesses. It is not known whether these clinics use evidence-based medicine or how they compare with other after-hours settings, such as emergency departments. This information would be important to health care practitioners, consumers and policy makers. Clinical practice guidelines have been developed on the basis of evidence from randomized control led trials for a number of acute paediatric illnesses. The objective of clinical practice guidelines is to aid clinicians in practising evidence-based medicine with the ultimate goal of improving patient care (3). A relatively high degree of adherence to evidence-based guidelines is expected. For example, more than 80% of medical treatments for adult illness were evidence-based at a university-affiliated district hospital in the United Kingdom (4). We chose to study the after-hours treatment of acute otitis media (AOM) because considerable evidence from clinical trials exists regarding its treatment, a Canadian clinical practice guideline has been developed and the treatment of AOM plays a significant role in the development of antibiotic resistance. AOM is the leading cause for antibiotic prescriptions in North America (5). It has been estimated that, on average, children spend over a month on antibiotic therapy for AOM in the first two years of life (6). Thus, the treatment of AOM has become a research priority to curtail the increasing prevalence of antibiotic-resistant bacteria while maintaining a cost effective treatment strategy (7). The natural history of AOM is such that 80% of all cases resolve spontaneously in seven to 14 days without antibiotic treatment (5–8). The rate of clinical resolution rises to 95% with antimicrobial treatment and there appears to be no significant difference in the efficacy of treatment regardless of which of the antibiotics indicated for AOM are used (7–9). Most North American experts agree that antimicrobial therapy is the standard of care for AOM (9–11) because of the statistically significant improvement in outcome when antibiotics are used to treat AOM and because complications of AOM such as hearing loss, mastoiditis and brain abscesses have become rare since the dawn of the antibiotic era. Amoxicillin is generally considered the drug of first choice because of its good side effect profile, low cost and high palatability (12–15). In July 1998, the Canadian Paediatric Society (CPS) released a position statement recommending standard dose amoxicillin (generally considered to be 40 mg/kg to 50 mg/kg per day) (16) for ten days as the first-line treatment for AOM (17). This statement was reaffirmed in February 2000 and, with respect to first-line therapy, is consistent with the most recent recommendations from the Center for Disease Control in Atlanta (18). Using these guidelines as a benchmark for the appropriate care of children with AOM, we examined guideline adherence in a paediatric after-hours clinic in a large Canadian city and compared this with adherence in a paediatric hospital emergency department and a general hospital emergency department in the same city.

Background This phase 3b, open label, controlled, multi-center, extension study (NCT02446743) assessed the persistence of bactericidal activity at 4 years post-primary vaccination with a recombinant, 4-component, meningococcal serogroup B vaccine (4CMenB) in adolescents who participated in the parent study NCT01423084 and their response to a booster dose, compared with that in vaccine-naïve healthy controls. Methods Adolescents and young adults previously primed with 4CMenB (2 doses; following a 0,1-month schedule) in study NCT01423084 (group 3B) and vaccine-naïve 15–22 year olds (group B0_1) were enrolled. Group 3B received a booster dose of 4CMenB at 4 years post-primary vaccination; group B0_1 received 2 catch-up doses of 4CMenB (following a 0,1-month schedule). Antibody persistence (primary objective) was evaluated at 4 years post-primary vaccination (in group 3B) vs. baseline (in group B0_1) using human serum bactericidal assay (hSBA), in terms of geometric mean titer (GMT) and percentage (%) of individuals with hSBA titer at least 4. Immune responses at 1 month after booster dose (in group 3B) vs. those at 1 month after first dose (in group B0_1) were also assessed. Results In group 3B, antibody levels declined from 1 month to 4 years post-primary vaccination against all antigens except NHBA, but were higher than in group B0_1 at baseline (Table), with a GMT ratio ≥1.3 and a difference in % of individuals with hSBA titer at least 4 of ≥9%. After one dose of 4CMenB (booster in 3B or first dose in B0_1), GMTs increased (≥4.6-fold in group 3B; ≥2.3-fold in group B0_1), and ≥94% of participants in group 3B and ≥41% of participants in group B0_1 had hSBA titer at least 4 (Table). Conclusion Antibody levels in adolescents and young adults primed with 4CMenB waned over time but were higher at 4 years post-primary vaccination than for vaccine-naïve individuals at baseline. A booster dose of 4CMenB in vaccine-primed individuals elicited higher immune responses than one dose of 4CMenB in vaccine-naïve individuals. The research was supported by GlaxoSmithKline Biologicals SA. Disclosures T. Nolan, GSK group of companies: Research Contractor and Scientific Advisor, Research grant. Pfizer: Research Contractor, Research grant. H. Garfield, Novartis/GSK group of companies: Investigator, Research support. A. Gupta, Novartis/GSK group of companies: Investigator, payment for research-related activities; M. Ferguson, GSK group of companies: Investigator, I receive salary from CRG. CRG has contracts with GSK. H. Marshall, GSK group of companies: Grant Investigator and Investigator, Research grant. Pfizer: Grant Investigator and Investigator, Research grant; sanofi pasteur: Grant Investigator, Research grant. Novavax: Investigator, Research grant. D. D’Agostino, GSK group of companies: Consultant, Consulting fee. D. Toneatto, GSK group of companies: Employee, Salary.

No research to date has descriptively catalogued what parents of healthy infants are naturalistically doing to manage their infant's pain over immunization appointments during the first year of life. This knowledge, in conjunction with an understanding of the relationships different parental techniques have with infant pain-related distress, would be useful when attempting to target parental pain management strategies in the infant immunization context. This study presents descriptive information about the pain management techniques parents have chosen and examines the relationships these naturalistic techniques have with infant pain-related distress during the first year of life. A total of 760 parent-infant dyads were recruited from 3 pediatric clinics in Toronto, ON, Canada, and were naturalistically followed and videotaped longitudinally over 4 immunization appointments during the infant's first year of life. Infants were full-term, healthy babies. Videotapes were subsequently coded for infant pain-related distress behaviors and parental pain management techniques. After controlling for preceding infant pain-related distress levels, parent pain management techniques accounted for, at most, 13% of the variance in infant pain-related distress scores. Across all age groups, physical comfort, rocking, and verbal reassurance were the most commonly used nonpharmacological pain management techniques. Pacifying and distraction appeared to be most promising in reducing needle-related distress in our sample of healthy infants. Parents in this sample seldom used pharmacological pain management techniques. Given the psychological and physical repercussions involved with unmanaged repetitive acute pain and the paucity of work in healthy infants, this paper highlights key areas for improving parental pain management in primary care.

Given the inherent variability in pain responding, using an "average" pain score may pose serious threats to internal and external validity. Using growth mixture modeling (GMM), this article first examines whether infants can be differentiated into stable groups based on their pain response patterns over a 2-minute post-needle period. Secondary analyses, to specifically address the issue of averaging pain scores to represent a sample, qualitatively described clinically meaningful differences between pain scores of the discerned groups and the overall mean (irrespective of groups). Infants were part of Canadian longitudinal cohort naturalistically observed during their 2-, 4-, 6-, and/or 12-month immunization appointments (N=458 to 574) at 3 pediatrician clinics between 2007 and 2012. At every age, GMM analyses discerned distinct groups of infants with significantly variable patterns of pain responding over the 2minutes post-needle. Our secondary suggested that the overall mean pain score immediately post-needle reflected most groups well at every age. However, for older infants (6 and 12months, especially), the overall mean pain responses at 1 and 2minutes post-needle significantly over or underestimated groups that contained 48% to 100% of the sample. These results combined highlight the significant variability of infant pain responding patterns between groups of infants and furthermore, calls into question the validity of using an overall mean in research with older infants during the regulatory phase post-needle.