At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 936 enrolled
Drug / intervention
13vPnC +1 morebiological
Likely dose
13vPnC 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 OPEN-LABEL TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN INFANTS AND YOUNG CHILDREN IN CHINA WHO ARE NAIVE TO PNEUMOCOCCAL VACCINATION
In Brief
A Phase 3 clinical trial evaluating 13vPnC and Hib for Pneumococcal Infections and Pneumococcal Conjugate Vaccine. Completed, enrolled 936 participants across 2 sites.
Detailed Summary
The purpose of this study is to assess the safety and immunogenicity of 13-valent Pneumococcal conjugate vaccine in Chinese infant and young children.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartJun 2018
First PostedJul 2018
Primary CompletionAug 2021
Study CompletionOct 2023
TodayJul 2026
First PostedJul 2, 2018
Enrollment StartJun 23, 2018
Primary CompletionAug 23, 2021
Study CompletionOct 13, 2023
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 8 years ago
Interventions
13vPnCbiological
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
Hibbiological
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose