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O009 - A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, ACTIVE-COMPARATOR-CONTROLLED STUDY TO EVALUATE CONCOMITANT ADMINISTRATION OF PEDIATRIC VACCINES WITH A 4-DOSE REGIMEN OF V114 IN HEALTHY INFANTS (PNEU-PED) (ID 458)
Abstract
Background
Pneumococcal disease remains a global health priority in both children and adults. Therefore, development of effective pneumococcal conjugate vaccines (PCVs) with higher valency are needed to address the increase in disease caused by non-vaccine serotypes. V114 is a 15-valent PCV containing all 13 serotypes in Prevnar 13™ (PCV13), and additional serotypes 22F and 33F. This pivotal study evaluated safety and immunogenicity of V114 when co-administered with other routine pediatric vaccines.
Methods
A total of 1720 healthy infants were randomized 1:1 to receive a 4-dose regimen of V114 or PCV13. Safety was evaluated as the proportion of participants with adverse events (AEs). Antibody responses to pediatric vaccines given concomitantly with either V114 or PCV13 were evaluated at 30 days post-infant series (7 months of age) for Pentacel™ (DTaP, Hib, polio), and at 30 days post-toddler dose (13-16 months of age) for VAQTA™, M-M-R™II, VARIVAX™, and HIBERIX™.
Results
The proportion, nature, and maximum intensity of injection-site, systemic, and serious AEs were generally comparable between V114 and PCV13 intervention groups. Compared to PCV13, V114 met non-inferiority criteria for all concomitantly administered vaccines as assessed by antibody responses to diphtheria, tetanus, pertussis, polio, and Hib/PRP antigens in infants, as well as antibody responses to hepatitis A, measles, mumps, rubella, varicella, and Hib/PRP antigens in toddlers.
Conclusions
In healthy infants, V114 can be given concomitantly with other standard of care pediatric vaccines without clinical interference on the expected safety and immunogenicity performance of each individual vaccine.