CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 102 enrolled
Drug / intervention
V116 +1 morebiological
Likely dose
V116 2 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/NCT04665050
NCT04665050Phase 1Completed
CompareCT.gov

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.

Merck Sharp & Dohme LLC·interventional·Posted Dec 11, 2020·Updated Oct 4, 2023

In Brief

A Phase 1 clinical trial evaluating V116 and PNEUMOVAX™23 for Pneumococcal Infection. Completed, enrolled 102 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumococcal Infection
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedDec 11, 2020
Enrollment StartFeb 4, 2021
Primary CompletionApr 6, 2021
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 5.6 years ago

Interventions

V116biological

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

PNEUMOVAX™23biological

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