CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 405 enrolled
Drug / intervention
20-valent pneumococcal conjugate vaccinebiological
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.

Search/NCT05875727
NCT05875727Phase 3Completed

A PHASE 3, SINGLE-ARM, MULTICENTER TRIAL TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS ≥18 YEARS OF AGE IN INDIA

Pfizer·interventional·Posted May 25, 2023·Updated Oct 24, 2024

In Brief

A Phase 3 clinical trial evaluating 20-valent pneumococcal conjugate vaccine for Pneumococcal Disease. Completed, enrolled 405 participants across 8 sites.

Detailed Summary

The purpose of this study is to learn about the safety and immune response of 20vPnC in adults in India. This study is seeking participants who: * are generally healthy adults of 18 years or older. * have not received pneumococcal vaccine. The study will have 2 groups based on age. One group will have particpants between 18 to 49 years of age. The other group will have participants of 50 years or older. Participants will take part in the study for about one month which includes two visits to the study clinic. Participants will receive a single dose of study vaccine (20vPnC) into the arm at visit 1 and will come to study site for a follow-up visit after about a month. The study team will ask questions about the participant's health and blood samples will be taken in a subset of participants during the visits.

Study Details

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

Timeline

Phase 3CompletedFinished
202420252026
First PostedMay 25, 2023
Enrollment StartAug 16, 2023
Primary CompletionOct 2, 2023
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 3.1 years ago

Interventions

20-valent pneumococcal conjugate vaccinebiological

One dose of 20vPnC will be administered intramuscularly.