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Article Abstract
Background: Pneumococcal disease (PD) remains a major health concern with considerable morbidity and mortality in children. Currently licensed pneumococcal conjugate vaccines (PCVs) confer protection against PD caused by most vaccine serotypes, but non-vaccine serotypes contribute to residual disease. V114 is a 15-valent PCV containing all 13 serotypes in Prevnar 13™ (PCV13) and additional serotypes 22F and 33F. This pivotal phase 3 study compared safety and immunogenicity of V114 and PCV13.
Methods: 1720 healthy infants were randomized 1:1 to receive a 4-dose regimen of V114 or PCV13 concomitantly with other routine pediatric vaccines. Safety was evaluated after each dose as proportion of participants with adverse events (AEs). Serotype-specific anti-pneumococcal immunoglobulin G (IgG) was measured at 1-month post-dose 3 (PD3), pre-dose 4, and 1-month post-dose 4 (PD4). IgG response rates, geometric mean concentrations (GMCs), and opsonophagocytic activity (OPA) were compared between vaccination groups.
Results: The proportion, maximum intensity, and duration of injection-site, systemic, and serious AEs were generally comparable between V114 and PCV13 groups. In comparison to PCV13, V114 met non-inferiority criteria for all 15 serotypes based on IgG response rates at PD3. V114 met non-inferiority criteria by IgG GMCs for all serotypes at PD3 and PD4, except for serotype 6A at PD3. V114-induced antibodies had bactericidal activity as assessed by OPA. Further, V114 met superiority criteria for shared serotype 3 and unique serotypes 22F and 33F compared to PCV13 by serotype-specific IgG GMCs at both PD3 and PD4. Immunogenicity of concomitantly administered routine pediatric vaccines was comparable in V114 and PCV13 groups.
Conclusions: In healthy infants, V114 displays acceptable safety and tolerability profiles and generates comparable immune responses to PCV13. V114 also met superiority criteria for serotypes 3, 22F, and 33F. These results support use of V114 for prevention of PD as part of routine infant vaccination schedules.
Trial Registration: ClinicalTrials.gov: NCT03893448; EudraCT: 2018-004109-21.
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Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in Japanese healthy infants: A phase III study (V114-033).
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July 2023
Clinical Research, Japan Development, MSD K.K., Tokyo, Japan.
Article Synopsis
- - This phase III study assessed the safety and immune response of the V114 vaccine, which targets 15 types of pneumococcal bacteria, in Japanese infants compared to the existing PCV13 vaccine.
- - Healthy infants received three doses of either V114 or PCV13, and researchers closely monitored adverse events and immune response levels after vaccinations at certain intervals.
- - Results showed V114 was well tolerated and produced comparable immune responses to the 13 shared serotypes found in PCV13, with significantly better responses for two additional serotypes, 22F and 33F.
A Phase III, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of V114 compared with PCV13 in healthy infants (PNEU-PED-EU-1).
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MSD (UK) Limited, London, United Kingdom.
Background: V114 (15-valent pneumococcal conjugate vaccine [PCV]) contains all serotypes in 13-valent PCV (PCV13) and additional serotypes 22F and 33F. This study evaluated safety and immunogenicity of V114 compared with PCV13 in healthy infants, and concomitant administration with DTPa-HBV-IPV/Hib and rotavirus RV1 vaccines.
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- V114 is a new 15-valent pneumococcal conjugate vaccine (PCV) that includes two additional serotypes (22F and 33F) beyond those covered by the current PCV13 vaccine.
- In a study with 1,720 healthy infants, V114 was found to have a similar safety profile to PCV13, with no significant increase in adverse events.
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