CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,409 enrolled
Drug / intervention
V114 +1 morebiological
Likely dose
V114 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/NCT03692871
NCT03692871Phase 3Completed
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A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety and Tolerability of V114 in Healthy Infants (PNEU-LINK)

Merck Sharp & Dohme LLC·interventional·Posted Oct 2, 2018·Updated Jul 28, 2023

In Brief

A Phase 3 clinical trial evaluating V114 and Prevnar 13™ for Pneumococcal Infections. Completed, enrolled 2,409 participants across 76 sites in 10 countries.

Detailed Summary

This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in healthy infants. This study will include both full-term infants (≥37 weeks gestational age) and premature infants (\<37 weeks gestational age). Premature infants will be included in a Premature Infant Immunogenicity Substudy, which will assess immunogenicity and safety following administration of V114 or Prevnar 13™.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumococcal Infections
CountriesAustralia, Canada, Finland, Germany, Israel, Malaysia, Peru, Taiwan, Thailand, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedOct 2, 2018
Enrollment StartDec 14, 2018
Primary CompletionMar 26, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.8 years ago

Interventions

V114biological

V114 pneumococcal capsular polysaccharide 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

Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 ml dose