NCT05329259

A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pneumococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	13-valent pneumococcal conjugate vaccine	One dose of 13vPnC (0.5mL) will be administered intramuscularly.

Timeline

• Start date: 2022-10-06
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2022-04-14
• Last updated: 2024-04-26
• Results posted: 2024-04-26

Locations

5 sites across 1 country: India