NCT05875727

A Study to Learn About the Safety and Immune Response of 20vPnC in Adults in India.

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 405 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pneumococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	20-valent pneumococcal conjugate vaccine	One dose of 20vPnC will be administered intramuscularly.

Timeline

• Start date: 2023-08-16
• Primary completion: 2023-10-02
• Completion: 2023-10-02
• First posted: 2023-05-25
• Last updated: 2024-10-24
• Results posted: 2024-10-24

Locations

8 sites across 1 country: India

Regulatory

• FDA-regulated drug study