CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 338 enrolled
Drug / intervention
V114 Medium Dose +4 morebiological
Likely dose
V114 Medium Dose 2 mcgfrom 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/NCT02531373
NCT02531373Phase 2Completed

A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of Different Formulations of V114 in Healthy Adults and Infants

Merck Sharp & Dohme LLC·interventional·Posted Aug 24, 2015·Updated Apr 2, 2019

In Brief

A Phase 2 clinical trial evaluating V114 Medium Dose, V114 High Dose, and 3 other interventions for Pneumococcal Infections. Completed, enrolled 338 participants.

Detailed Summary

This study is designed to assess the effect of different dose levels of pneumococcal polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and infants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 24, 2015
Enrollment StartSep 15, 2015
Primary CompletionApr 14, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.9 years ago

Interventions

V114 Medium Dosebiological

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose

V114 High Dosebiological

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) in each 0.5 mL dose

V114 Medium Dose with Alternative Carrier Proteinbiological

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg), and Merck Aluminum Phosphate Adjuvant (125 mcg) with alternative carrier protein in each 0.5 mL dose

V114 High Dose with Alternative Carrier Proteinbiological

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) with alternative carrier protein in each 0.5 mL dose

Prevnar 13™biological

13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose