CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 717 enrolled
Drug / intervention
V116 +2 morebiological
Likely dose
V116 4 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05420961
NCT05420961Phase 3Completed

A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older

Merck Sharp & Dohme LLC·interventional·Posted Jun 16, 2022·Updated Oct 26, 2024

In Brief

A Phase 3 clinical trial evaluating V116, PCV15, and 1 other intervention for Pneumonia, Pneumococcal. Completed, enrolled 717 participants across 51 sites in 9 countries.

Detailed Summary

This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, France, Israel, Italy, Japan, South Korea, Spain, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedJun 16, 2022
Enrollment StartJul 12, 2022
Primary CompletionMay 16, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.0 years ago

Interventions

V116biological

Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the 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

PCV15biological

Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, and 4 μg of 6B in each 0.5 mL sterile suspension

PPSV23biological

Pneumococcal 23-valent vaccine with 25 μg of each of the 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