NCT06177912

A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Children and Adolescents With Increased Risk of Pneumococcal Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 882 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children and teenagers 2 through 17 years of age, who had completed routine pneumococcal vaccine as infants/toddlers. Researchers want to learn if V116 is as good as, or is better than the PPSV23 vaccine in terms of the antibody immune response. V116 and PPSV23 will be studied in children and teenagers who have a higher risk of getting pneumococcal disease (PD).

Conditions

• Pneumococcal Infection

Interventions

Type	Name	Description
BIOLOGICAL	V116	Pneumococcal 21-valent conjugate vaccine with 4 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	PPSV23	Pneumococcal 23-valent conjugate 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: 2024-01-18
• Primary completion: 2025-02-26
• Completion: 2025-02-26
• First posted: 2023-12-20
• Last updated: 2026-03-11
• Results posted: 2026-03-11

Locations

92 sites across 13 countries: United States, Canada, Chile, Colombia, Finland, France, Israel, Japan, Poland, Spain, Sweden, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study