Immunogenicity of a quadrivalent human papillomavirus vaccine in pediatric kidney and liver transplant recipients.

BACKGROUND: Solid-organ transplant recipients are at increased risk of developing human papillomavirus-related diseases. METHODS: To evaluate the immunogenicity of a quadrivalent vaccine, a prospective observational study included females aged 12-19 years who had received kidney or liver transplants, or were otherwise healthy volunteers. With the three-dose vaccination, serum antibodies were measured. RESULTS: The study included 17 transplant recipients (seven kidney and 10 liver) and 16 healthy participants. Six of seven kidney transplant recipients were on three immunosuppressive medications, whereas 9 of the 10 liver transplant recipients were on one. For the serology within 6 months from the last vaccine dose, the geometric mean titers of human papillomavirus types 6, 11, 16, and 18 were 26.7, 8.6, 35.7, and 42.4 (kidney transplant); 579.2, 569.3, 3097.3, and 835.7 (liver transplant); and 860.5, 638.8, 4391.6, and 902.6 milli-Merck Units/ml (healthy). The seropositivity rates of kidney transplant recipients for the four serotypes ranged from 50% to 75%, while all liver transplant recipients and healthy participants had 100% seropositivity rates for all four types. While there were no statistical differences of titers between liver transplant recipients and healthy participants, the titers of kidney transplant recipients were lower than those of healthy participants for type 6 (p = .034), type 11 (p = .032), and type 16 (p = .032). CONCLUSIONS: The results support the recommendation of human papillomavirus vaccination in pediatric transplant recipients given the significant risk of human papillomavirus-related diseases in this population, though immunogenicity was lower in kidney transplant recipients on multiple immunosuppressive medications.

A Measure of Caregivers' Distress-Promoting Behaviors During Toddler Vaccination: Validation of the OUCHIE-RV.

OBJECTIVE: The current study discusses the development and preliminary validation of an observational measure of caregivers' distress-promoting behavior (OUCHIE-RV) in the context of toddler routine vaccination. METHODS: Measure validation was based on a sample of caregiver-toddler dyads (N = 223) from a longitudinal cohort-sequential study who were observed during toddlers' 12-, 18-, or 24-month routine vaccinations. Validity was assessed using correlations and cross-lagged path analysis and associations were tested between OUCHIE-RV composite scores and toddlers' pain-related distress as well as caregivers' state anxiety, soothing behaviors, heart rate, and heart rate variability. Interrater reliability was examined using intraclass correlations (ICC) and kappa coefficients. RESULTS: Results of a cross-lagged path analysis indicated positive concurrent (ß = .27 to ß = .37) and cross-lagged predictive associations (ß = .01 to ß = .34) between OUCHIE-RV composite scores (reflecting the frequency and intensity of caregivers' distress-promoting behavior) and toddlers' pain-related distress. OUCHIE-RV composite scores were negatively associated with caregivers' concurrent use of physical comfort (r = -.34 to -.24) and rocking (r = -.36 to -.19) and showed minimal associations with caregivers' use of verbal reassurance (r = .06 to .12), state anxiety (r = -.02 to r = .09), heart rate (r = -.15 to r = .05), and heart rate variability (r = -.04 to r = .13). Interrater reliability was strong (Cohen's k = .86 to .97, ICC = .77 to .85). CONCLUSIONS: Findings provide support for the validity and reliability of the OUCHIE-RV as a research tool for measuring caregiver behaviors that promote toddlers' pain-related distress during routine vaccinations and contribute to a better understanding of the dynamics of caregiver-toddler interaction in acute pain contexts.

Caregiver Ratings of Toddler Pain: The Role of Caregiver Psychological Predictors.

INTRODUCTION/AIM: Young children's limited ability to self-report pain necessitates an understanding of the factors that influence pain ratings. The current paper examines the relative prediction of caregiver psychological factors and toddler pain behaviors on caregiver pain ratings post-vaccination. METHODS: One hundred fifty-six parent-toddler dyads were video recorded during pediatric vaccinations. Child pain behaviors were coded before, during, and after the needle using the Face, Legs, Activity, Cry, Consolability Scale and the Neonatal Facial Coding System). Caregivers rated their child's pain after the needle, reported pre- and post-needle worry during the visit, and completed rating scales assessing other areas of psychological functioning within 2 weeks after the appointment. Regression models were estimated to examine the relative contribution of child and caregiver factors to the prediction of caregiver pain ratings. RESULTS: The regression model predicting caregiver pain ratings from the toddlers' pain-related distress (facial activity immediately after the needle, overall pain-related behavior immediately after, 1-min and 2-min post-needle) and caregiver worry were significant (adjusted R-square = 0.21), with caregiver pre- and post-needle worry being the only significant predictors of caregiver pain ratings. CONCLUSIONS: This study outlines that although child distress behavior remains a significant influence on pain ratings during toddlerhood, when caregiver worry (pre- and post-needle) was entered into the model, they were the only significant predictors of caregiver pain ratings.

Investigating convergence of cardiac and behavioral indicators of distress during routine vaccinations over the second year of life.

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.

Parental Psychological Distress Moderates the Impact of a Video Intervention to Help Parents Manage Young Child Vaccination Pain.

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.

Featured Article: The ABCDs of Pain Management: A Double-Blind Randomized Controlled Trial Examining the Impact of a Brief Educational Video on Infants' and Toddlers' Pain Scores and Parent Soothing Behavior.

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.

Understanding the concurrent and predictive relations between child-led emotion regulation behaviors and pain during vaccination in toddlerhood.

ABSTRACT: The purpose of this study was to further our understanding of early childhood pain-related distress regulation. Concurrent and predictive relations between child-led emotion regulation (ER) behaviors and pain-related distress during vaccination were examined at 2 different ages using autoregressive cross-lagged path analyses. Toddlers were video-recorded at the 12- and 18-month routine vaccination appointments (12-month-old [N = 163]; 18-month-old [N = 149]). At 1, 2, and 3 minutes postneedle, videos were coded for 3 clusters of child-led ER behaviors (disengagement of attention, parent-focused behaviors, and physical self-soothing) and pain-related distress. The concurrent and predictive relations between child-led ER behaviors and pain-related distress behaviors were assessed using 6 models (3 emotion regulation behaviors by 2 ages). At 18 months, disengagement of attention was significantly negatively related to pain-related distress at 1 minute postneedle, and pain-related distress at 1 minute postneedle was significantly related to less disengagement of attention at 2 minutes postneedle. Parent-focused behaviors had significant positive relations with pain-related distress at both ages, with stronger magnitudes at 18 months. Physical self-soothing was significantly related to less pain-related distress at both ages. Taken together, these findings suggest that disengagement of attention and physical self-soothing may serve more of a regulatory function during toddlerhood, whereas parent-focused behaviors may serve more of a function of gaining parent support for regulation. This study is the first to assess these relations during routine vaccination in toddlerhood and suggests that toddlers in the second year of life are beginning to play a bigger role in their own regulation from painful procedures than earlier in infancy.

Distinct trajectories of caregiver-toddler physiological attunement during routine vaccinations.

Introduction: Toddlers rely on their caregivers for regulatory support when faced with pain-related distress. The caregiver's ability to support their toddler relies on their capacity to regulate their own distress and respond effectively to the child's need for support. The aim of the current study was to describe patterns of caregiver-toddler physiological co-regulatory patterns, also known as attunement, during routine vaccinations across the second year of life. Methods: Caregiver-toddler dyads (N = 189) were part of a longitudinal cohort observed at either 12-, 18-, or 24-month well-baby vaccinations. Parallel-process growth-mixture modeling was used to examine patterns of dyadic physiological co-regulatory responses, indexed by high-frequency heart rate variability (HF-HRV). Results: Three groups of dyads were discerned. The largest group (approximately 80%) demonstrated physiological attunement, with a stable and parallel regulatory pattern of HF-HRV from baseline to postneedle. The second group (7.9%) had parallel regulatory trajectories but with notably lower (ie, less regulated) HF-HRV values, which indicates independent regulatory responses (ie, a lack of attunement among dyad members). The third group (11.1%) showed diverging regulatory trajectories: Caregivers showed a stable regulatory trajectory, but toddlers demonstrated a steep decrease followed by an increase in HF-HRV values that surpassed their baseline levels by the third minute postneedle. Post hoc analyses with the HF-HRV groupings explored heart rate patterns and potential predictors. Conclusions: These findings elucidate potential adaptive and maladaptive co-regulatory parasympathetic patterns in an acute pain context.

Caregiver and Child Distress as Predictors of Dyadic Physiological Attunement During Vaccination.

OBJECTIVE: Previous research discerned 3 groups of caregiver-toddler dyads that differed in their physiological coregulatory patterns, also known as physiological attunement, during routine vaccinations in the second year of life. One group of dyads (80% of sample) displayed an attuned regulatory pattern, and 2 groups of dyads (20% of sample) showed maladaptive attunement patterns (ie, a lack of attunement or misattunement). The objective of the current study was to examine how well the pain-related distress of children and caregivers during vaccination predicted these patterns. METHODS: Caregiver-toddler dyads (N = 189) were part of a longitudinal cohort observed at either 12-, 18-, or 24-month vaccination appointments. The caregiver's self-report of worry was assessed before and after the needle, and the child behavioral pain-related distress was also measured during the vaccination appointment. Logistic regression was used to determine how well these variables predicted caregiver-child physiological attunement patterns, as indexed by high-frequency heart rate variability. RESULTS: Higher behavioral pain-related distress at various timepoints after the needle were associated with membership in the dyad groups that showed misattunement or lack of attunement. Further, caregivers with higher preneedle worry and lower postneedle worry had a greater likelihood of belonging to groups that showed a maladaptive attunement pattern. DISCUSSION: Findings suggest that caregivers who experience distress associated with their toddlers' vaccination experience more difficulty coregulating with their child during vaccination, and these children are at risk of experiencing higher levels of pain-related distress. This research highlights the need to help caregivers support their children's regulation during vaccination.

A longitudinal examination of verbal reassurance during infant immunization: occurrence and examination of emotional availability as a potential moderator*.

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 = 376 at 2 months, n = 455 at 4 months, n = 484 at 6 months, and n = 407 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.

Trajectories of distress regulation during preschool vaccinations: child and caregiver predictors.

ABSTRACT: Recent research has highlighted the need for a deeper understanding of the heterogeneity in trajectories of children's distress after acute pain exposure, moving beyond the group means of behavioural pain scores at a single timepoint. During preschool vaccinations, 3 distinct trajectories of postvaccination pain regulation have been elucidated, with approximately 75% of children displaying trajectories characterized by downregulation to no distress by 2 minutes postneedle and 25% concerningly failing to downregulate by 2 minutes. The objective of this study was to examine child and caregiver predictors of preschool children's postvaccination regulatory patterns. Our results indicated that higher child baseline distress, more caregiver coping-promoting verbalizations in the first minute after the needle, less coping-promoting verbalizations in the second minute, and more caregiver distress-promoting verbalizations in the second minute after the needle were associated with membership in the trajectories characterized by high distress. Furthermore, although all children's pain-related distress at various timepoints throughout the appointment was most strongly predicted by previous pain scores, different patterns of associations emerged depending on the trajectory exhibited. This research highlights both the need to minimize distress before the needle to avoid the highly distressed trajectory and 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.

Continuing Medical Education Improves Physician Communication Skills and Increases Likelihood of Pediatric Vaccination: Findings from the Pediatric Influenza Vaccination Optimization Trial (PIVOT)-II.

This study evaluated the impact of a continuing medical education (CME) program that emphasized actionable information, motivation to act, and skills to strengthen physician recommendations for seasonal influenza vaccination in children 6 through 23 months of age for whom influenza immunization rates are suboptimal. Physicians were randomly assigned to an accredited CME program or to no CME. Participants completed pre- and post-study questionnaires. Influenza immunization rates were compared between groups. A total of 33 physicians in the CME group and 35 in the control group documented 292 and 322 healthy baby visits, respectively. Significantly more parents immunized their children against influenza after interacting with CME-trained physicians than those with no CME training (52.9% vs. 40.7%; p = 0.007). The odds ratio for vaccination after visits with CME-trained physicians was 1.52 (95% confidence interval 1.09 to 2.12; p = 0.014), which was unaffected by the socioeconomic status of parents. Parents who discussed influenza vaccination with CME-trained physicians were 20% more likely to choose an approved but publicly unfunded adjuvanted pediatric influenza vaccine. The percentages of physicians reporting the highest levels of knowledge, ability, and confidence doubled or tripled after the CME intervention. Significantly more parents immunized very young children after interacting with physicians who had undergone CME training.

Clinicians Are Not Able to Infer Parental Intentions to Vaccinate Infants with a Seasonal Influenza Vaccine, and Perhaps They Should Not Try: Findings from the Pediatric Influenza Vaccination Optimization Trial (PIVOT)-IV.

This prospective cohort survey evaluated the concordance of clinicians' perceptions of parental intentions and parents' actual intentions to vaccinate their infants against influenza. During a routine healthy baby visit, clinicians provided parents with information about influenza, children's vulnerability to influenza, and nonadjuvanted and adjuvanted trivalent influenza vaccines (TIV and aTIV, respectively). Before and after the clinician−parent interaction, parents were surveyed about their attitudes, their perceptions of support from significant others, and the intention to vaccinate their infant with aTIV. Clinicians were asked about their perception of parents' intentions to choose aTIV for their children. These assessments included 24 clinicians at 15 community practices and nine public health clinics, and 207 parents. The correlation coefficients of the clinicians' assessment of parents' intention to vaccinate were 0.483 (p < 0.001) if the vaccine was presented as free of cost, 0.266 (p < 0.001) if the cost was $25, and 0.146 (p = 0.036) if the cost was $50, accounting for 23%, 7%, and 2% of the variance in parental intentions, respectively. The clinicians were poor at predicting parental intentions to immunize, particularly when cost was involved. Information on vaccine options and influenza infection should be provided for every eligible patient to allow parents to determine if the vaccine is appropriate for their child.

Parental Attitudes and Perceptions of Support after Brief Clinician Intervention Predict Intentions to Accept the Adjuvanted Seasonal Influenza Vaccination: Findings from the Pediatric Influenza Vaccination Optimization Trial (PIVOT)-I.

Adjuvanted trivalent influenza vaccine (aTIV) provides enhanced protection against seasonal influenza in children compared with nonadjuvanted trivalent influenza vaccine (TIV). This prospective cohort study assessed parental attitudes, beliefs, and intentions to vaccinate their infants aged 6-23 months with aTIV. Parents were surveyed before and after routine healthy baby visits, and post clinician interaction results were analyzed using multivariable logistic regression. Physicians at 15 community practice clinics and nurses at 3 public health clinics participated; 207 parents were surveyed. After clinician consultation, most parents considered immunization with aTIV to be safe (72.9%), effective (69.6%), and important (69.0%); most perceived support for vaccination from significant others (62.8%) and clinicians (81.6%); and 66.6% intended to vaccinate their infant with aTIV. Parental attitudes toward vaccinating their infant with aTIV were strongly correlated with perceptions of vaccine safety, efficacy, and importance, and these represented the strongest influence on intentions to vaccinate (odds ratio (OR) 79.25; 95% confidence interval (CI) 6.05-1037.50). Parental intentions were further influenced by perceived strength of clinician recommendation (OR 4.55, 95% CI 1.38-15.06) and social support for vaccination (OR 3.46, 95% CI 0.50-24.13). These findings may inform clinician approaches to parental education to ensure optimal seasonal pediatric influenza vaccination.

Understanding the Impact of Approved but Unfunded Vaccine Status on Parental Acceptance of an Adjuvanted Seasonal Influenza Vaccine for Infants: Results from the Pediatric Influenza Vaccination Optimization Trial (PIVOT)-III.

The adjuvanted trivalent influenza vaccine (aTIV) provides enhanced protection against influenza for infants but is not publicly funded (NPF). The objective of this prospective cohort study of parents with children 6 through 23 months of age was to understand how NPF status influences parental perceptions of approved but unfunded vaccines and their intentions to vaccinate. At healthy baby visits, clinicians provided parents with information about influenza and vaccination. Before and after these interactions, a research nurse assessed parents' intentions to vaccinate their children and their beliefs about the safety, efficacy, and necessity of vaccinating their children with aTIV in both publicly funded (PF) and NPF settings. Overall, 15 community practice clinics (n = 15 physicians) and nine public health clinics (n = 9 nurses) recruited 207 parents. The percentage of parents intending to immunize their children with aTIV decreased from 72% (vaccine PF, free of charge), to 42% (NPF, $25 per dose), to 27% (NPF, $50 per dose). Funding status strongly influenced whether parents perceived immunization with aTIV to be necessary, safe, and effective. Information on influenza and influenza vaccines should be provided to parents routinely to allow for well-informed decisions on the suitability of specific influenza vaccines for their child.

Longitudinal and concurrent relationships between caregiver-child behaviours in the vaccination context and preschool attachment.

ABSTRACT: 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.

An examination of the reciprocal and concurrent relations between behavioral and cardiac indicators of acute pain in toddlerhood.

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.

Parental Report of Self and Child Worry During Acute Pain: A Critical Factor in Determining Parental Pain Judgment.

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.

Antibody persistence and booster response in adolescents and young adults 4 and 7.5 years after immunization with 4CMenB vaccine.

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-naïve 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-naïve participants of similar age (Naïve_4y and Naïve_7.5y groups). Primed participants received a booster dose; vaccine-naïve 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-naïve), 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-naïve 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-naïve 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-naïve participants. A more robust immune response after booster compared to a first dose in vaccine-naïve individuals, showed effective priming in an adolescent/young adult population. No safety or new reactogenicity issues were identified.

Measuring the Impact of Rotavirus Acute Gastroenteritis Episodes (MIRAGE): A prospective community-based study.

BACKGROUND: Current assessments of the burden of rotavirus (RV)-related gastroenteritis are needed to evaluate the potential benefits of RV immunization interventions. The objective of the present study was to characterize the burden of RV gastroenteritis among children presenting in outpatient settings with gastroenteritis. METHODS: Between January and June 2005, 395 children younger than three years of age presenting with gastroenteritis symptoms (at least three watery or looser-than-normal stools, or forceful vomiting within the previous 24 h period) were recruited from 59 Canadian clinics and followed for two weeks. Stool specimens were tested for the RV antigen. Gastroenteritis-related symptoms, health care utilization, parental work loss and other cases of gastroenteritis in the household were assessed by questionnaires and daily symptom cards that were completed by caregivers. RESULTS: Of 336 conclusive test results, 55.4% were RV positive (RV+). In addition to diarrhea, 67.2% and 89.3% of RV+ children experienced fever or vomiting, respectively. Compared with RV-negative (RV-) children, RV+ children were more likely to experience the three symptoms concurrently (57.0% versus 26.7%; P<0.001), to be hospitalized (12.9% versus 3.9%; P=0.008) and to induce parental work loss (53.8% versus 37.3%; P=0.003). The median duration of gastroenteritis was eight days for RV+ children (nine days for RV- children). Additional cases of gastroenteritis were present in 46.8% of households in the RV+ group (51.3% of households in the RV- group). CONCLUSIONS: RV gastroenteritis cases were more severe than other gastroenteritis cases, were hospitalized more often and were associated with considerably more work loss.