CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 253 enrolled
Drug / intervention
V114 +1 morebiological
Likely dose
V114 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/NCT02573181
NCT02573181Phase 2Completed
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A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Adults 65 Years of Age or Older Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine

Merck Sharp & Dohme LLC·interventional·Posted Oct 9, 2015·Updated Aug 14, 2019

In Brief

A Phase 2 clinical trial evaluating V114 and Prevnar 13™ for Pneumococcal Infections. Completed, enrolled 253 participants.

Detailed Summary

This study is designed to assess the safety, tolerability, and immunogenicity of V114 compared with Prevnar 13™ in healthy adults 65 years of age or older previously vaccinated with 23-valent pneumococcal polysaccharide vaccine.

Study Details

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

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 9, 2015
Enrollment StartOct 30, 2015
Primary CompletionJan 28, 2016
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 10.7 years ago

Interventions

V114biological

V114 contains 2 µg of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F, and 4 μg of serotype 6B; and 30 µg of CRM₁₉₇ and 125 µg of Aluminum Phosphate Adjuvant (APA) per 0.5 mL dose.

Prevnar 13™biological

Prevnar 13™ contains 2.2 μg of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F, and 4.4 μg of serotype 6B; and 34 μg of CRM₁₉₇ and 125 μg of aluminum per 0.5mL dose.