At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 301 enrolled
Drug / intervention
13vPnCbiological
Likely dose
Not stated in 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 4, RANDOMIZED, OPEN-LABEL TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 13- VALENT PNEUMOCOCCAL CONJUGATE VACCINE FORMULATED IN MULTIDOSE VIALS WHEN GIVEN WITH ROUTINE PEDIATRIC VACCINES IN HEALTHY INFANTS IN INDIA
In Brief
A Phase 4 clinical trial evaluating 13vPnC for Vaccines. Completed, enrolled 301 participants across 7 sites.
Detailed Summary
A Phase 4 Study To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaccines
CountriesIndia
Collaborators--
Timeline
Phase 4CompletedFinished
20192020202120222023202420252026
Enrollment StartMay 2018
First PostedJun 2018
Primary CompletionDec 2019
TodayJul 2026
First PostedJun 7, 2018
Enrollment StartMay 31, 2018
Primary CompletionDec 20, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.1 years ago
Interventions
13vPnCbiological
13vPnC MultiDose Vial with preservative compared to a Prefilled syringe containing 13vPnC without any preservative