STRIDE-13 Finds V116 Immunogenic in At-Risk Children and Adolescents
Key Takeaways
- V116 was associated with noninferior responses for serotypes shared with PPSV23 and stronger responses for serotypes unique to V116.
- The study enrolled previously vaccinated children and adolescents aged 2 to <18 years with diabetes mellitus or chronic heart, lung, kidney, and or liver disease.
- Overall adverse-event proportions were generally comparable between the V116 and PPSV23 groups.
The phase 3 trial enrolled children and adolescents aged 2 to <18 years who had medical conditions linked to increased pneumococcal risk. Eligible conditions included diabetes mellitus and chronic heart, lung, kidney, and or liver disease. Participants had completed a primary pneumococcal vaccination regimen before study entry. They were randomized 3:2 to a single dose of V116, with 531 participants, or PPSV23, with 351 participants, establishing the comparison in a previously vaccinated at-risk pediatric cohort.
30-day immunogenicity endpoints included opsonophagocytic activity geometric mean titers and immunoglobulin G geometric mean concentrations. For opsonophagocytic activity geometric mean titers, V116 met the noninferiority criterion for the serotypes shared with PPSV23 and the superiority criterion for serotypes unique to V116. Immunoglobulin G geometric mean concentrations followed the same overall pattern across those serotype groups. Both immune readouts pointed in the same direction across the assessed measures.
Safety was evaluated by the proportion of participants who reported adverse events after vaccination. Overall adverse-event proportions were generally comparable between the V116 and PPSV23 groups. The authors described V116 as immunogenic and well tolerated in this population. They presented the findings as supporting broader pneumococcal serotype coverage in populations at increased risk.