Merck’s Capvaxive Receives the US FDA’s Accelerated Approval to Prevent Invasive Pneumococcal Disease and Pneumonia in Adults
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- The approval was based on P-III studies of Capvaxive across STRIDE-3 (vs PCV20) in pneumococcal vaccine-naïve adults (≥18yrs.), STRIDE-5 (concomitantly with Influenza vaccine) in adults (≥50yrs.) & STRIDE-6 in pneumococcal vaccine-experienced adults
- STRIDE-3 depicted non-inferior immune responses in all 10 serotypes (both vaccines) & superior responses for 10/11 serotypes included in V116 (not in PCV20) at D30 in cohort 1 & non-inferior immune responses in cohort 2 vs 1
- STRIDE-5 showed non-inferiority to sequential administration for 20/21 Capvaxive serotypes & 3/4 QIV strains; STRIDE-6 showed OPA responses similar to PCV15 serotypes (6 common, 15 unique & 15B in cohort 1) & PPSV23 serotypes (12 common, 9 unique, 15B in cohort 2) with consistent responses in all 3 cohorts
Ref: Merck | Image: Merck
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
