Merck’s capvaxive shows positive immune response in pneumococcal disease

Merck (MRK) announced positive results from the Phase 3 STRIDE-13 trial evaluating capvaxive – Pneumococcal 21-valent Conjugate Vaccine – at the 6th European Society of Clinical Microbiology and Infectious Diseases Conference on Vaccines, taking place in Lisbon, Portugal. The trial evaluated the safety, tolerability and immunogenicity of capvaxive compared to PPSV23 in children and adolescents aged 2 to less than18 years who have completed a primary pediatric pneumococcal vaccination regimen and have one or more chronic medical conditions that put them at an increased risk of pneumococcal disease. Key findings from the STRIDE-13 study include: capvaxive elicited immune responses to all 21 serotypes – or strains – as assessed by serotype-specific opsonophagocytic activity geometric mean titers at 30 days post-vaccination – secondary immunogenicity endpoint -; capvaxive was noninferior to PPSV23 for each of the 12 serotypes shared between the vaccines and superior to PPSV23 for each of the nine serotypes unique to capvaxive, as measured by serotype-specific OPA GMTs at 30 days post-vaccination – primary immunogenicity endpoint. The proportions of participants with adverse events were generally comparable between groups. Capvaxive is currently approved in the U.S., EU, Japan and multiple other countries around the world, based on safety and immunogenicity data from the Phase 3 STRIDE clinical program.