A PHASE 3, MULTICENTER, RANDOMISED, DOUBLEBLIND, ACTIVE-COMPARATOR-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A 4-DOSE REGIMEN OF V114 IN HEALTHY INFANTS (PNEU-PED)

OpenAlex İngilizce

Aims Pneumococcal disease (PD) remains a major health concern globally. Pneumococcal conjugate vaccines (PCVs) confer protection against PD caused by most vaccine serotypes, but residual disease remains partly due to non-vaccine serotypes. V114 is a 15-valent PCV containing all 13 serotypes in Prevnar 13™ (PCV13) and serotypes 22F and 33F. This phase 3 study compared safety and immunogenicity of V114 and PCV13 in infants. Methods A total of 1720 healthy infants 6 to 12 weeks of age were randomised 1:1 to receive a 4-dose regimen of V114 or PCV13. Safety was evaluated as the proportion of participants with adverse events (AEs). Serotype-specific immunoglobulin G (IgG) and opsonophagocytic activity (OPA) responses were measured 1 month post-dose 3 (PD3), pre-dose 4, and 1 month post-dose 4 (PD4). Results The proportion, nature, maximum intensity, and duration of injection-site, systemic, and serious AEs were generally comparable between recipients of V114 and PCV13. No serious AEs were reported to be vaccine related. In comparison to PCV13, V114 met non-inferiority criteria for all 15 serotypes based on IgG response rates at PD3. V114 further met non-inferiority criteria based on IgG GMCs for all serotypes at PD3 and PD4 except serotype 6A at PD3. V114-induced antibodies displayed functional activity as assessed by OPA. Conclusion In healthy infants, V114 has an acceptable safety profile and generates comparable quantitative and qualitative immune responses to the 13 serotypes shared with PCV13, with higher responses to serotypes unique to V114. These results support use of V114 in infant immunisation.