What is RSVpreF studying for respiratory syncytial virus (RSV)?

This clinical trial is studying the safety and immune response of the RSVpreF vaccine in adults. Researchers want to understand how well the vaccine triggers immunity and how safe it is for people, including those with certain stable chronic health conditions. The study is sponsored by Pfizer and helps gather important information to prevent RSV infections.

Who may be eligible for this respiratory syncytial virus (RSV) clinical trial?

Adults 18 years and older who live independently and are ambulatory may be eligible. Participants should be healthy or have stable chronic medical conditions like heart or lung disease, diabetes, or other listed conditions. People with serious illnesses or severe allergies to vaccines are not eligible. Please review eligibility criteria for more details.

Is there any cost to participate in this respiratory syncytial virus (RSV) clinical trial?

Study-related care, including the vaccine and all trial visits, is provided at no cost. However, personal travel and other expenses are not guaranteed to be covered and may vary. Participants should plan accordingly for any costs related to their participation.

Actively Recruiting

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

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

Who Can Participate

Age: 18Years +

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Participants 18 years of age or older.
Ambulatory individuals who live independently in the community.
Participants deemed eligible by medical history, physical exam (if needed), and investigator judgment.
For ages 18 to 59: Healthy or stable chronic medical conditions including chronic heart disease, chronic lung disease, diabetes type 1 or 2, severe obesity (BMI ≥40 kg/m2), chronic liver disease, chronic kidney disease (excluding end-stage renal disease), chronic neurological disease affecting airway clearance or respiratory muscles, or chronic hematologic disease.
Chronic conditions must have lasted 6 months or more and require regular medical follow-up, ongoing medication, or hospitalization within the past year.
Ability to provide informed consent and comply with study requirements.

You will not qualify if you...

Bleeding disorders or conditions causing prolonged bleeding that contraindicate intramuscular injections.
History of severe adverse or allergic reactions to vaccines or vaccine components.
Previous diagnosis of any Guillain-Barré syndrome.
Serious chronic disorders such as metastatic cancer, end-stage renal disease with or without dialysis, unstable cardiac disease, or other investigator-determined exclusions.
Known or suspected immunodeficiency.
Use of chronic systemic immunosuppressive treatments within 60 days before or planned during the study, including cytotoxic agents, immunosuppressive monoclonal antibodies, systemic corticosteroids, or radiotherapy.

Research Team

Pfizer CT.gov Call Center

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