CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,152 enrolled
Drug / intervention
V114 Aluminum-adjuvanted +2 morebiological
Likely dose
V114 Aluminum-adjuvanted 2.2 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT01215188
NCT01215188Phase 2Completed
CompareCT.gov

A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of Pneumococcal Conjugate Vaccine (V114) Compared to Prevnar 13™ in Healthy Infants

Merck Sharp & Dohme LLC·interventional·Posted Oct 6, 2010·Updated Apr 30, 2019

In Brief

A Phase 2 clinical trial evaluating V114 Aluminum-adjuvanted, V114 Non-adjuvanted, and 1 other intervention for Pneumococcal Infections. Completed, enrolled 1,152 participants.

Detailed Summary

This study will evaluate whether the aluminum-adjuvanted or the non-adjuvanted formulation of the candidate pneumococcal vaccine (V114) is non-inferior to Prevnar 13® based on immune responses to the 13 serotypes in common Prevnar 13®

Study Details

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

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 6, 2010
Enrollment StartOct 14, 2010
Primary CompletionJul 31, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.7 years ago

Interventions

V114 Aluminum-adjuvantedbiological

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.2 mcg each), serotype 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.

V114 Non-adjuvantedbiological

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) 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 each), serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose.