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First received: January 13, 2023

Clinical Trial: Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008)

Study Status: ACTIVE_NOT_RECRUITING

Recruit Status: ACTIVE_NOT_RECRUITING

Condition: Pneumococcal Infection

Study Type: INTERVENTIONAL


Official Title: A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 18 to 64 Years of

Brief Summary: The primary objectives of this study are to evaluate the safety and tolerability of the pneumococcal 21 valent conjugate vaccine (V116), and to evaluate the serotype-specific opsonophagocytic activity (OPA) post-vaccination with V116 and PCV15 (a pneumococcal conjugate vaccine that includes 15 serotypes) + PPSV23 (comprised of the polysaccharides from 23 of the serotypes causing disease in adults) post-vaccination.within each vaccination group separately.

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