Key Highlights
- Phase 3 STRIDE-13 trial shows CAPVAXIVE induced immune responses to all 21 serotypes, with superiority over PPSV23 in nine unique serotypes.
- Findings highlight CAPVAXIVE’s potential to expand pneumococcal protection to children and adolescents with chronic medical conditions.
- Merck plans to share results with global regulatory authorities, signaling momentum toward broader approval beyond adults.
Promising Phase 3 Data from STRIDE-13 Trial
Merck announced that CAPVAXIVE demonstrated robust immunogenicity and safety in the Phase 3 STRIDE-13 trial, presented at the 6th ESCMID Conference on Vaccines. The study evaluated children and adolescents aged 2 to under 18 years with chronic conditions increasing pneumococcal disease risk. CAPVAXIVE was noninferior to PPSV23 for the 12 shared serotypes and superior for the nine serotypes unique to CAPVAXIVE, covering a broader range of invasive pneumococcal strains.
Expanding Protection to Vulnerable Pediatric Populations
Children with chronic conditions such as diabetes, chronic heart or lung disease, and kidney disorders remain especially vulnerable to pneumococcal infections. Results suggest CAPVAXIVE could extend significant protection to these groups, covering approximately 78% of invasive pneumococcal disease (IPD) cases in at-risk youth, compared to narrower coverage with existing vaccines.
Safety Profile Comparable to PPSV23
The safety and tolerability profile of CAPVAXIVE was consistent with expectations, with adverse event rates comparable to PPSV23. Most reported side effects were mild to moderate, including injection-site pain, fatigue, and headache. Importantly, serious vaccine-related adverse events were rare, reinforcing CAPVAXIVE’s suitability for pediatric use.
Regulatory Pathway and Global Impact
These results mark the final readout of the STRIDE clinical program, paving the way for regulatory submissions. Already approved in the U.S., EU, Japan, and other markets for adult use, CAPVAXIVE now demonstrates strong potential for pediatric expansion. If approved, it could become the first pneumococcal vaccine designed to comprehensively protect both adults and children, reshaping global immunization strategies.
About Merck
Merck, known as MSD outside the U.S. and Canada, is a global research-driven biopharmaceutical leader committed to using science to save and improve lives. With more than 130 years of innovation, Merck continues to advance vaccines, medicines, and health solutions for people worldwide, with a focus on prevention and long-term impact.
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