CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 150 enrolled
Drug / intervention
Prevnar™ +2 morebiological
Likely dose
Prevnar™ 2.2 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/NCT01215175
NCT01215175Phase 1Completed
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A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of Pneumococcal Conjugate Vaccine (V114) Compared to Prevnar™ in Healthy Adults and Toddlers

Merck Sharp & Dohme LLC·interventional·Posted Oct 6, 2010·Updated Mar 18, 2019

In Brief

A Phase 1 clinical trial evaluating Prevnar™, V114, Aluminum Adjuvanted, and 1 other intervention for Pneumococcal Infections. Completed, enrolled 150 participants.

Detailed Summary

This study is being conducted to evaluate the safety, tolerability, and immunogenicity of 15-valent pneumococcal conjugate vaccine (V114) compared to Prevnar™ in healthy adults and toddlers.

Study Details

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

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 6, 2010
Enrollment StartSep 25, 2009
Primary CompletionApr 16, 2010
Study CompletionJan 5, 2011
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 15.7 years ago

Interventions

Prevnar™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) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.

V114, Aluminum Adjuvantedbiological

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.0 mcg each), serotype 6B (4.0 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.

V114, Aluminum Nonadjuvantedbiological

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.0 mcg each), serotype 6B (4.0 mcg) in each 0.5 mL dose.