- Phase 3 STRIDE-13 trial results presented at the 6th ESCMID Conference on Vaccines.
- CAPVAXIVE covers 21 serotypes, outperforming PPSV23 in immune response.
- Safety profile of CAPVAXIVE is comparable to PPSV23.
- CAPVAXIVE is approved in the U.S., EU, Japan, and other countries.
Trial Overview
Merck announced positive results from the Phase 3 STRIDE-13 trial of CAPVAXIVE, a 21-valent pneumococcal conjugate vaccine, at the 6th ESCMID Conference on Vaccines in Lisbon. The trial assessed safety, tolerability, and immunogenicity in children and adolescents aged 2 to <18 years with chronic conditions increasing pneumococcal disease risk.
Key Findings
CAPVAXIVE elicited immune responses to all 21 serotypes, showing noninferiority to PPSV23 for 12 shared serotypes and superiority for 9 unique serotypes. Safety profiles were comparable between CAPVAXIVE and PPSV23, with similar rates of adverse events.
Regulatory Status
Results will be shared with global regulatory authorities. CAPVAXIVE is approved in the U.S., European Union, Japan, and other countries based on safety and immunogenicity data from the Phase 3 STRIDE program.
Potential Impact
CAPVAXIVE is designed to cover serotypes causing the majority of invasive pneumococcal disease (IPD) in adults and offers additional protection for at-risk children and adolescents. It covers approximately 78% of IPD cases in this group, with 11 unique serotypes accounting for about 34% of cases.
