CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 341 enrolled
Drug / intervention
Prevnar 13® +5 morebiological
Likely dose
Prevnar 13® 2.2 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/NCT02037984
NCT02037984Phase 2Completed
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A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults and Infants

Merck Sharp & Dohme LLC·interventional·Posted Jan 16, 2014·Updated Jun 24, 2019

In Brief

A Phase 2 clinical trial evaluating Prevnar 13®, V114 1x:1x:1x, and 4 other interventions for Streptococcus Pneumoniae Infection and Pneumococcal Infections. Completed, enrolled 341 participants.

Detailed Summary

This study is designed to assess the safety, tolerability, and immunogenicity of 5 different formulations of V114 in healthy adults and infants. Adults only will be enrolled in Period 1 and infants only will be enrolled in Period 2; Period 1 will complete prior to the start of Period 2.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStreptococcus Pneumoniae Infection, Pneumococcal Infections
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 16, 2014
Enrollment StartJan 28, 2014
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 12.5 years ago

Interventions

Prevnar 13®biological

Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 µg each), and 6B (4.4 µg) in each 0.5 mL dose.

V114 1x:1x:1xbiological

V114 1x:1x:1x contains 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of Aluminum Phosphate Adjuvant (APA).

V114 2x:2x:2xbiological

V114 2x:2x:2x contains 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA.

V114 2x:1x:2xbiological

V114 2x:1x:2x contains 4.0 μg of polysaccharide serotypes 6A, 18C, 19A, 19F, and 23F; 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 7F, 9V, 14, 22F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA.

V114 1x:1x:2xbiological

V114 1x:1x:2x contains 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA.

V114 0.5x:0.5x:2xbiological

V114 0.5x:0.5x:2x contains 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA.