CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 200 enrolled
Drug / intervention
13-valent pneumococcal conjugate vaccinebiological
Likely dose
13-valent pneumococcal conjugate vaccine 0.5mLfrom 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/NCT05329259
NCT05329259Phase 4Completed
CompareCT.gov

A PHASE 4, OPEN-LABEL, SINGLE-ARM, MULTICENTER STUDY TO DESCRIBE THE SAFETY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS 18 TO 49 YEARS OF AGE IN INDIA

Pfizer·interventional·Posted Apr 14, 2022·Updated Apr 26, 2024

In Brief

A Phase 4 clinical trial evaluating 13-valent pneumococcal conjugate vaccine for Pneumococcal Disease. Completed, enrolled 200 participants across 5 sites.

Detailed Summary

* The purpose of this study is to describe the safety of the study vaccine (called 13vPnC) in people who are 18-49 years of age in India. * This study is seeking participants who are generally healthy adults ≥18 and \<50 years of age, with no prior history of pneumococcal vaccination. * Participants will take part in the study for approximately one month which includes two visits to the study clinic. * Participants will receive a single dose of study vaccine (13vPnC) into the arm at visit 1 and will come to study site for a follow-up visit after about a month.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumococcal Disease
CountriesIndia
Collaborators--

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedApr 14, 2022
Enrollment StartOct 6, 2022
Primary CompletionNov 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 4.2 years ago

Interventions

13-valent pneumococcal conjugate vaccinebiological

One dose of 13vPnC (0.5mL) will be administered intramuscularly.