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NCT Number: NCT07819097

A Study to Learn About the Safety and Immune Responses of RSVpreF in Older Adults

The purpose of this study is to learn about the safety, tolerability, and immune response of the RSVpreF vaccine in healthy older adults.

Participants will take part in this study for about 6 months.

The study will include people in China and the United States. In China, participants will receive either RSVpreF or placebo. A placebo is a dummy vaccine with no active ingredient, but it looks just like the vaccine being studied. In the United States, all participants will receive RSVpreF.

Researchers will check for any reactions. They will also check blood test results to learn how the body responds to the vaccine.

The main questions the study aims to answer are:

* What local reactions and systemic events (body-wide symptoms) do participants have after a RSVpreF vaccination? * What medical problems do participants have after a RSVpreF vaccination? * Researchers will compare antibody levels from blood tests between the China cohort and the US cohort. An antibody is a substance in the body that try to fight off an infection or foreign substance.

Participants will:

* Have a screening visit to make sure they qualify for the study (participants in China will have this visit before the day of vaccination) * Receive the RSVpreF vaccination (or a placebo injection if in the China cohort) once at Visit 1. * Have a telephone or clinic visit 1 week later to assess local reactions and systemic events. * Have a clinic visit a month after vaccination for a checkup and tests. * Have a telephone or clinic visit 6 months after vaccination for a health check. * Have a blood test at screening (if in the China cohort only), on the day of vaccination and 1 month after vaccination.

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Key information

Conditions

Adult Healthy Participants

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Huashan Hospital Fudan University, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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: [email protected]

Treatment and study plan

RSVpreF

Biological

Single Dose

Placebo

Other

Single Dose

Primary outcomes

  1. Percentage of participants reporting local reactions: pain at the injection site, redness, and swelling

    Time frame: Within 7 days after vaccination

  2. Percentage of participants reporting systemic events: fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain

    Time frame: Within 7 days after vaccination

  3. Percentage of participants reporting adverse events (AEs)

    Time frame: Within 1 month after vaccination

  4. Percentage of participants reporting serious adverse events (SAEs)

    Time frame: Through 6 months after vaccination

  5. Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs)

    Time frame: Through 6 months after vaccination

  6. RSV A and RSV B neutralizing antibody levels before vaccination and 1 month after vaccination

    Time frame: Before vaccination and 1 month after vaccination

  7. Geometric mean fold rise in RSV A and RSV B neutralizing antibody levels from before vaccination to 1 month after vaccination

    Time frame: Before vaccination to 1 month after vaccination

Secondary outcomes

  1. Seroresponse rate for RSV A and RSV B neutralizing antibody levels

    Time frame: 1 month after vaccination

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

AN INTERVENTIONAL PHASE 3 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN PARTICIPANTS 60 YEARS OF AGE AND OLDER

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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