At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 58 enrolled
Drug / intervention
V114biological
Likely dose
V114 0.5 mLfrom 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.
A Phase 3, Single-Arm, Open-label Clinical Study to Evaluate the Safety and Immunogenicity of 4 Doses of V114 Administered to Healthy Infants in South Korea.
In Brief
A Phase 3 clinical trial evaluating V114 for Pneumococcal Disease. Completed, enrolled 58 participants across 19 sites.
Detailed Summary
The primary purpose of this phase 3, single-arm, open-label study is to evaluate the safety and immunogenicity of a 4-dose regimen of V114 administered to healthy infants in South Korea.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumococcal Disease
CountriesSouth Korea
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedNov 2020
Enrollment StartFeb 2021
Primary CompletionNov 2022
TodayJul 2026
First PostedNov 18, 2020
Enrollment StartFeb 10, 2021
Primary CompletionNov 4, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.6 years ago
Interventions
V114biological
15-valent pneumococcal conjugate vaccine (PCV) containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in Prevnar 13™ plus 2 additional serotypes (22F, 33F) in each 0.5 mL sterile suspension for intramuscular injection.