NCT03950856

Lot-to-Lot Consistency of V114 in Healthy Adults (V114-020)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,340 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The primary objectives are to evaluate the safety and tolerability of V114 and to compare the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) across 3 different lots of V114. The primary hypothesis is that all 3 lots of V114 are equivalent as measured by the serotype-specific OPA GMTs for 15 serotypes in V114 at 30 days postvaccination.

Conditions

• Pneumococcal Infections
• Pneumonia, Pneumococcal

Interventions

Type	Name	Description
DRUG	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.
DRUG	Prevnar 13™	13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F in each 0.5. mL dose.

Timeline

• Start date: 2019-06-12
• Primary completion: 2020-04-03
• Completion: 2020-04-03
• First posted: 2019-05-15
• Last updated: 2021-04-12
• Results posted: 2021-04-12

Locations

55 sites across 6 countries: United States, Australia, Chile, Denmark, Finland, United Kingdom

Regulatory

• FDA-regulated drug study