RSVpreF vaccine in older adults: safety and immune response

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 interventional trial evaluates the safety, tolerability, and immune response to the RSVpreF vaccine in healthy adults aged 60 and older. In China, participants are randomized to receive RSVpreF or placebo, while in the United States all participants receive RSVpreF. Participants will be followed for about six months, with monitoring of local and systemic reactions, adverse events, and antibody responses from blood tests. The study also compares antibody levels between the China and US cohorts to understand potential geographic differences in immune response. Primary goals include identifying safety signals and characterizing immune responses after vaccination.

Why it matters

Who can join: the full rules

Key Inclusion Criteria

* Participants 60 years of age or older at enrolment.
* Healthy participants, or participants with stable long-term medical conditions, if the investigator decides they can take part.
* Adults who can walk and live in the community or in assisted-living/long-term care settings with minimal help.
* Participants who can give signed informed consent and follow study visits and procedures, including the 7-day electronic diary and blood tests.

Key Exclusion Criteria

* Confirmed RSV infection 180 days or less before study vaccination.
* Any past history of Guillain-Barré syndrome.
* Severe reaction to a vaccine or severe allergy to a study vaccine component or related vaccine.
* Serious or unstable medical condition that the investigator believes makes the study unsafe.
* Immunocompromised status, based on medical history and/or examination.
* Previous receipt of any licensed or investigational RSV vaccine or RSV preventive monoclonal antibody, or planned receipt during the study.

Please refer to the study contact for further eligibility details Contacts/Locations Central Contact Person: Pfizer CT.gov Call Center Telephone: 1-800-718-1021 Email: ClinicalTrials.gov\_Inquiries@pfizer.com

Where it's running

• Huashan Hospital Fudan University
  Shanghai, Shanghai Municipality, China Recruiting
• Headlands Research - Scottsdale
  Scottsdale, Arizona, United States Not yet recruiting
• Orange County Research Center
  Lake Forest, California, United States Not yet recruiting
• Artemis Institute for Clinical Research
  Riverside, California, United States Not yet recruiting
• Clinical Research Consulting, LLC
  Milford, Connecticut, United States Not yet recruiting
• George Washington University
  Washington D.C., District of Columbia, United States Not yet recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.