A phase 3, randomized study to evaluate the safety, tolerability, and immunogenicity of V116 in children and adolescents with increased risk of pneumococcal disease (STRIDE-13) - PubMed
4 hours ago
- #pneumococcal vaccine
- #clinical trial
- #pediatric immunology
- This phase 3 randomized study evaluated V116, a 21-valent pneumococcal conjugate vaccine, compared to PPSV23 in children/adolescents aged 2 to <18 years with medical conditions increasing pneumococcal disease risk, after primary vaccination.
- Participants with conditions like diabetes, chronic heart/lung/kidney/liver disease were randomized 3:2 to V116 (n=531) or PPSV23 (n=351), assessing immunogenicity via OPA GMTs and IgG GMCs at 30 days post-vaccination and safety via adverse events.
- V116 met noninferiority criteria for 12 serotypes shared with PPSV23 and superiority for 9 unique serotypes based on OPA GMTs; IgG results were consistent, and safety profiles were comparable between groups.
- The study concludes V116 is well-tolerated and immunogenic, supporting its use to broaden serotype coverage in children/adolescents at increased risk of pneumococcal disease.