NCT05425732

Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,663 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Pneumococcal Infection

Interventions

Type	Name	Description
BIOLOGICAL	V116	0.5 mL injection solution in prefilled syringe containing 4 μg of each PnPs antigen (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B) given by intramuscular (IM) injection.
BIOLOGICAL	PCV20	0.5 mL injection suspension in prefilled syringe containing 2.2 μg of each PnPs antigen (1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F) and 4.4 μg of PnPs antigen 6B.

Timeline

• Start date: 2022-07-13
• Primary completion: 2023-05-18
• Completion: 2023-05-18
• First posted: 2022-06-21
• Last updated: 2024-10-26
• Results posted: 2024-06-10

Locations

112 sites across 11 countries: United States, Australia, Belgium, Chile, Germany, New Zealand, Puerto Rico, South Korea, Sweden, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study