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The V116 pneumococcal vaccine is a new option in children at risk for pneumococcal disease

Presented by
Dr Vinita Jagannath, Merck & Co., Inc., NJ, USA
Conference
ESCMID Vaccines 2025
The 21-valent pneumococcal vaccine V116 provided comparable or superior efficacy to PPSV23 with an acceptable safety profile in children and adolescents at increased risk of pneumococcal disease. 

Dr Vinita Jagannath (Merck & Co., Inc., NJ, USA) presented results from the phase 3 trial STRIDE-13 (NCT06177912),  a randomised, controlled, double-blind study comparing V116 with PPSV23. Participants were children and adolescents aged ≥2 to <18 years who had completed primary pneumococcal vaccination and were considered at risk due to underlying medical conditions. Endpoints included safety, non-inferiority of V116 to PPSV23 for 12 common serotypes (3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, 33F) and superiority for 9 serotypes unique to V116 (6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, 35B) assessed by opsonophagocytic activity at 30 days post-vaccination. In total, 531 participants received V116 and 351 received PPSV23 [1].  

Vaccine-related injection-site adverse events (AEs) were more common with V116 than with PPSV23 (72.5% vs 58.2%), but vaccine-related systemic AEs occurred at similar rates (43.8% vs 40.6%). Solicited AEs were generally comparable between groups, except for injection-site pain (67.7% vs 54.5%) and erythema (24.3% vs 16.4%), which were more frequent with V116.  

At 30 days post-vaccination, V116 was non-inferior to PPSV23 for all 12 common serotypes (see Figure) and met the criteria for superiority for the 9 serotypes unique to V116. 

Figure. Serotype-specific OPA GMT ratios for common serotypes [1] 



CI, confidence interval; OPA, opsonophagocytic activity; GMT, geometric mean titre. 

“In children and adolescents, V116 is well tolerated, with a safety profile generally comparable to that of PPSV23”, concluded Dr Jagannath. “V116 elicits robust immune responses to all 21 serotypes included in the vaccine and met the predefined non-inferiority criteria. Therefore, it has the potential to broaden coverage in children and adolescents at risk of pneumococcal disease.” 

  1. Jagannath V, et al. A Phase 3, Randomised, double-blind study to evaluate safety and immunogenicity of V116, a pneumococcal conjugate vaccine, in children and adolescents with increased risk of pneumococcal disease (STRIDE-013). 6th ESCMID Vaccines, 10–13 September 2025, Lisbon, Portugal. 

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