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A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)

Pneumococcal Disease Clinical Trial

Official title:
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

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05464420
Study type Interventional
Source Merck Sharp & Dohme LLC
Contact
Status Completed
Phase Phase 3
Start date August 12, 2022
Completion date May 25, 2023
View Details
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