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Concomitant use of VAQTA with PedvaxHIB and Infanrix in 12 to 17 month old children.

ABSTRACT: Open-label, multicenter, randomized study (NCT00289913) evaluated immunogenicity, safety, and tolerability of Vaqta (hepatitis A vaccine) administered with PedvaxHIB (Haemophilus b conjugate vaccine [Meningococcal protein conjugate]) & Infanrix (diphtheria/tetanus/acellular pertussis vaccine) in healthy, 15-month-old children. Five groups were evaluated: Group 1 received Vaqta/Infanrix PedvaxHIB on Day-1 and Vaqta at Week-24; Group 2 received Infanrix PedvaxHIB on Day-1, Vaqta at Week-4, and Vaqta at Week-28; Group 3 received Vaqta/PedvaxHIB on Day-1 and Vaqta Week-24; Group 4 received PedvaxHIB on Day-1, Vaqta at Week-4, and Vaqta at Week-28; and Group 5 (safety only) received Vaqta on Day-1 and Vaqta at Week-24. Hepatitis A seropositivity rate (SPR: ?10 mIU/mL), Hib capsular polyribosylribitol phosphate (PRP) antibody response (>1.0 ?g/mL), and geometric mean titers (GMT) to pertussis toxin (PT), pertussis filamentous hemagglutinin antibody (FHA), and pertactin were examined. Non-inferiority statistical criteria required a difference >10% in Hepatitis A SPR, PRP >1.0 ?g/mL, and a GMT ratio of >0.67 for pertussis antigens. Injection-site and systemic adverse events (AEs) and daily temperatures were collected. Hepatitis A SPRs were 100% for Groups 1-4, regardless of initial serostatus. Anti-PRP titers were comparable (98.1% - 97.0%) for Groups 1-4. GMT and mean fold-rise were comparable for all 3 pertussis antigen components between concomitant and nonconcomitant groups. Criteria for non-inferiority of immune responses for concomitant vs nonconcomitant administration were met for Hepatitis A, Hib, and pertussis antigens. No statistically significant incidence differences of individual AEs were found between concomitant and nonconcomitant groups. No serious vaccine-related AEs or deaths were reported; no subject discontinued due to an AE. Immune responses to Vaqta, PedvaxHIB, and Infanrix given concomitantly were non-inferior to nonconcomitant responses. Vaqta administered with PedvaxHIB & Infanrix had an acceptable safety profile in 15-month-old children.

SUBMITTER: Petrecz M

PROVIDER: S-EPMC5049725 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Concomitant use of VAQTA with PedvaxHIB and Infanrix in 12 to 17 month old children.

Petrecz Maria M Ramsey Keith P KP Stek Jon E JE Martin Jason C JC Klopfer Stephanie O SO Kuter Barbara B Schödel Florian P FP Lee Andrew W AW

Human vaccines & immunotherapeutics 20160101 2

Open-label, multicenter, randomized study (NCT00289913) evaluated immunogenicity, safety, and tolerability of Vaqta (hepatitis A vaccine) administered with PedvaxHIB (Haemophilus b conjugate vaccine [Meningococcal protein conjugate]) & Infanrix (diphtheria/tetanus/acellular pertussis vaccine) in healthy, 15-month-old children. Five groups were evaluated: Group 1 received Vaqta/Infanrix PedvaxHIB on Day-1 and Vaqta at Week-24; Group 2 received Infanrix PedvaxHIB on Day-1, Vaqta at Week-4, and Vaq ...[more]

PMID: 26308112

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Project description:BackgroundMetabolic programming of glucose homeostasis in the first 1,000 days of life may impact lifelong metabolic and cardiovascular health. Continuous glucose monitoring (CGM) devices may help measure the impact of dietary intake on glucose rhythms and metabolism in infants during the complementary feeding period.ObjectivesDemonstrate the feasibility of CGM to measure and quantify glucose variability in response to infant feeding and to evaluate associations between macronutrient meal composition and glucose variability.MethodsThe "FreeStyle Libre Pro®" device interstitial glucose meter was applied to the anterior thigh of 10 healthy 6-12-month-old infants. Parents recorded food intake, time of feeding, and used daily dairies to record sleep time and duration. Descriptive statistics were employed for food intake, sleep and key glycemic parameters over three full days. Mixed linear models were used to assess glycemic changes.ResultsMid-day, afternoon, and evening feeds contained >30 g carbohydrate and induced higher 2-h iAUC (3.42, 3.41, and 3.50 mmol/L*h respectively) compared to early and mid-morning feedings with ≤25 g carbohydrates (iAUC 2.72 and 2.81 mmol/L*h, p < 0.05). Early morning and evening milk feedings contained approximately 9 g of fat and induced a longer time to reach maximal glucose value (Tmax; 75 and 68 min, respectively) compared to lower fat feedings (2.9-5.9 g; Tmax range: 34-60 min; p < 0.05). Incremental glucose value at time of food intake (C0) increased significantly from 0.24 ± 0.39 mM in early morning to 1.07 ± 0.57 mM in the evening (p < 0.05). Over the day, 70% of glucose values remained within the normal range (3.5-5.5 mmol/L), 10% were between 5.5-10 mmol/L, and 20% were < 3.5 mmol/L.ConclusionOur data support the feasibility of using CGM to measure glucose in 6-12-month-old infants. The observation of possible diurnal glucose variability and typical glucose values may have implications for future studies investigating metabolic adaptation to nutritional intake in early life.

Project description:BackgroundImmunization is one of modern medicine's greatest achievements in the last three decades. Annually it can prevent nearly 2 to 3 million deaths. Understanding the determinants of effective immunization coverage is a critical undertaking. Accordingly, we set out to check the best available evidence of outstanding predictors of immunization coverage among children aged 12-23 months in Ethiopia.MethodElectronic databases including PubMed, Google Scholar, HINARI, and SCOPUS, Web of Science, African Journals Online, Ethiopian Medical Journals were searched. The search process, study selection, critical appraisal, and data extraction were done independently by two reviewers using Joanna Briggs Institute Meta-analysis for Review Instrument (JBI-MAStARI). The difference between reviewers was resolved with a third person. The risk of bias was assessed by the Newcastle Ottawa Tool for observational studies. Data were extracted using the Microsoft Excel checklist and exported to STATA 13. Heterogeneity was assessed using I2, Funnel plot and Egger's test was used to check for publication bias.ResultsWe identified 26 studies with 15,042 children with mothers/caretakers to assess factors associated with immunization coverage and significant factors were: maternal formal education, (OR = 2.45; 95% CI: 1.62-3.72), paternal formal education, (OR = 1.01; 95% CI: 0.27-3.77), residence, (OR = 2.11; 95% CI: 1.00-4.45), birth at health facility (OR = 1.86; 95% CI: 0.99-3.49), family size less than four, (OR = 1.81; 95% CI: 1.16-2.84), knowledge on age of immunization to be completed (OR = 6.18;95% CI: 3.07-12.43), knowledge on immunization schedule (OR = 2.49; 95% CI: 1.35-4.59), time to travel to health faculties, (OR = 1.74; 95% CI: 0.62-4.89), antennal care, (OR = 3.11; 95% CI: 1.64-5.88), and tetanus toxoid vaccination, (OR = 4.82; 95% CI: 2.99-7.75).ConclusionOur findings showed that literacy, residence, awareness, family size, maternal health services use, and proximity of the health facilities were factors associated with full immunization. This implies that there is a need for primary health service expansion and health education to "hard to reach areas" to improve immunization coverage for children aged 12-23 months.

Dataset Information

Concomitant use of VAQTA with PedvaxHIB and Infanrix in 12 to 17 month old children.

Publications

Concomitant use of VAQTA with PedvaxHIB and Infanrix in 12 to 17 month old children.

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