A Phase 3 Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults 18 to 49 Years of Age
A Phase 3 Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults 18 to 49 Years of Age
This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in pneumococcal vaccine-naïve adults 18 to 49 years of age.
The primary study hypothesis is that all 3 lots of V116 are equivalent as assessed by the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days postvaccination for all serotypes included in V116.
The key inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
Exclusion Criteria:
East Greenwich, Rhode Island 02818, United States
Tomball, Texas 77375, United States
Graz, Styria 8036, Austria
Sakhnin, 3081000, Israel
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796, Poland
Lublin, Lublin Voivodeship 20-095, Poland
Pozuelo de Alarcón, Madrid 28223, Spain
Valencia, Valenciana, Comunitat 46015, Spain