CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 133 enrolled
Drug / intervention
V114 +2 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/NCT03848065
NCT03848065Phase 1Completed
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A Phase I, Double-Blind, Randomized, Multicenter Trial of the Safety,Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants

Merck Sharp & Dohme LLC·interventional·Posted Feb 20, 2019·Updated Jan 15, 2025

In Brief

A Phase 1 clinical trial evaluating V114, Pneumococcal 13-valent Conjugate Vaccine (PCV13), and 1 other intervention for Pneumococcal Infections. Completed, enrolled 133 participants across 14 sites.

Detailed Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 administered subcutaneously or intramuscularly in healthy Japanese infants (3 months of age).

Study Details

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

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedFeb 20, 2019
Enrollment StartApr 2, 2019
Primary CompletionJun 24, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.4 years ago

Interventions

V114biological

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

Pneumococcal 13-valent Conjugate Vaccine (PCV13)biological

13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B in each 0.5. mL dose.

Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV)biological

Single SC dose of 0.5 mL at Visits 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).