Respiratory Syncytial Virus (RSV)

  • STATUS
    Recruiting
  • sponsor
    Pfizer
Updated on 18 April 2022

Summary

This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of RSVpreF in the prevention of moderate to severe LRTI-RSV in adults.

Description

  • Condition: Respiratory Syncytial Virus (RSV)
  • Clinical Trial Identifier: NCT05035212
  • Sponsor: Pfizer
Looking for participants within a 35 mile radius of the study site.

Details
Condition Vaccines
Clinical Study IdentifierTX290675
SponsorPfizer
Last Modified on18 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 60+
Adults who are ambulatory and live in the community, or in assisted living or long-term care residential facilities that provide minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living
Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol

Exclusion Criteria

Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine
Serious chronic disorder including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study
Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration
Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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