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Phase 3
Age: 18Years +
All Genders
Healthy Volunteers
ID07653100

Phase 3 Evaluation of RSVpreF Vaccine Safety and Immune Response in Indian Adults

Led by Pfizer · Updated on 2026-07-29

540

Participants Needed

13

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and immune response of the RSVpreF vaccine in adults living in India. This phase 3, multicenter, double-blinded, placebo-controlled study aims to learn how the vaccine affects adults, including those with certain stable chronic medical conditions that may increase their risk of respiratory syncytial virus RSV disease. The study is sponsored by Pfizer and focuses on prevention of RSV infection. Participants will be randomly assigned to receive either the RSVpreF vaccine or a placebo. The vaccine is given as an injection, and the study will monitor participants for local and systemic reactions within 7 days after vaccination, as well as adverse events through 1 month and serious adverse events for 3 months post-vaccination. The immune response will be measured by neutralizing antibody levels against RSV A and RSV B before vaccination and 1 month afterward. During the study, participants will be observed for safety and immune response through scheduled visits. Researchers will collect data on side effects, serious health events, and antibody levels. The study includes adults aged 18 and older who live independently and are ambulatory. Participation involves medical history review and physical exams as needed. The trial will continue until January 25, 2027, with assessments focused on vaccine safety and immune response over several months.

CONDITIONS

Brief Title

A Phase 3 Study in India to Describe the Safety and Immunogenicity of RSVpreF

Research Team

P

Pfizer CT.gov Call Center

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