NCT03950622

Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE)

A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults 50 Years of Age or Older (PNEU-AGE)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,205 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to 1) evaluate the safety and tolerability of V114 and 2) to compare the immune responses of the 15 serotypes contained in V114 with V114 versus Prevnar 13™. The primary hypotheses are that 1) V114 is noninferior to Prevnar 13™ as measured by the serotype specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for 13 shared serotypes at 30 days postvaccination and that 2) V114 is superior to Prevnar 13™ as measured by serotype-specific OPA GMTs for 2 unique serotypes in V114 at 30 days postvaccination.

Conditions

• Pneumococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	V114	15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in each 0.5 mL dose.
BIOLOGICAL	Prevnar 13®	13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in each 0.5 mL dose.

Timeline

• Start date: 2019-06-13
• Primary completion: 2020-03-30
• Completion: 2020-03-30
• First posted: 2019-05-15
• Last updated: 2021-04-26
• Results posted: 2021-03-18

Locations

30 sites across 5 countries: United States, Canada, Japan, Spain, Taiwan

Regulatory

• FDA-regulated drug study