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).
Hum Vaccin ImmunotherJun 23, 2026 (epub)
Vinita Jagannath, Jayani Pathirana, Carlos Alberto Perez Yepes et al.
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In 30 seconds
This phase 3 randomized controlled trial assessed the safety and immunogenicity of the 21-valent pneumococcal conjugate vaccine V116 in children and adolescents aged 2 to <18 years with chronic medical conditions. The study found that V116 met noninferiority for all 12 shared serotypes and superiority for 9 unique serotypes compared to PPSV23, indicating enhanced immunogenicity.
Key findings
- V116 met noninferiority for all 12 shared serotypes compared to PPSV23.
- V116 demonstrated superiority for each of the 9 unique serotypes based on OPA GMTs.
- The safety profile of V116 was generally comparable to that of PPSV23.
Why it matters
Pneumococcal disease poses a significant risk to children with chronic conditions. The findings suggest that V116 could provide broader serotype coverage, potentially improving protection in this vulnerable population.