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
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
This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine ([Prevnar 20™ / APEXXNAR™]) in pneumococcal vaccine-naïve adults. It is hypothesized that V116 is noninferior to PCV20 for the common serotypes and superior to PCV20 for the unique serotypes as assessed by serotype specific opsonophagocytic activity (OPA) 30 days postvaccination. It is also hypothesized that V116 in participants 18 to 49 years of age immunobridges to V116 in participants 50 to 64 years of age as assessed by serotype specific OPA geometric mean titers (GMTs) 30 days postvaccination for all 21 serotypes in V116. Participants ≥50 years of age will be enrolled in Cohort 1, and participants 18 to 49 years of age will be enrolled in Cohort 2.
Inclusion Criteria:
Exclusion Criteria:
Fountain Valley, California 92708, United States
Troy, Michigan 48098, United States
Las Vegas, Nevada 89119, United States
Horseheads, New York 14845, United States
Tomball, Texas 77375, United States
Temuco, Araucania 4781151, Chile
Providencia, Region M. de Santiago 7500000, Chile
Santiago, Region M. de Santiago 8330034, Chile
Caguas, 00725, Puerto Rico
Namdong-gu, Incheon 21565, South Korea
Suwon, Kyonggi-do 16247, South Korea
Suwon, Kyonggi-do 16499, South Korea
Deagu, Taegu-Kwangyokshi 41404, South Korea
Seoul, 03312, South Korea
Seoul, 03722, South Korea
Seoul, 07441, South Korea