NCT04665050

Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine (V116) in Japanese Adults (V116-002)

A Phase 1, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the safety, tolerability, and immunogenicity of a polyvalent pneumococcal conjugate vaccine (V116) with that of PNEUMOVAX™23 in healthy Japanese adults.

Conditions

• Pneumococcal Infection

Interventions

Type	Name	Description
BIOLOGICAL	V116	Pneumococcal 21-valent conjugate vaccine with 2 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
BIOLOGICAL	PNEUMOVAX™23	Pneumococcal 23-valent polyvalent vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution

Timeline

• Start date: 2021-02-04
• Primary completion: 2021-04-06
• Completion: 2021-04-06
• First posted: 2020-12-11
• Last updated: 2023-10-04
• Results posted: 2023-07-07

Locations

2 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study