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, according to data presented at the 2025 ESCMID Conference on Vaccines.

Dr Vinita Jagannath (Merck & Co., Inc., NJ, USA) presented results from the phase 3 trial STRIDE-013 (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 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 PPSV23.

Vaccine-related injection-site adverse events (AEs) were more common with V166 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 and met the criteria for superiority for the 9 serotypes unique to V116.

“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 disease.”

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). 6^th ESCMID Vaccines, 10–13 September 2025, Lisbon, Portugal.

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