Study to Evaluate the Efficacy, Immunogenicity, and Safety of RSVpreF in Adults. (RENOIR)

  • STATUS
    Recruiting
  • End date
    Jun 19, 2024
  • participants needed
    45000
  • sponsor
    Pfizer
Updated on 22 April 2022
Accepts healthy volunteers

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

This is a Phase 3, multicenter, randomized, double-blinded, placebo-controlled study to assess the safety, immunogenicity, and efficacy of RSVpreF or placebo (1:1 randomization) in adults. This will be a global study that will span multiple RSV seasons.

Details
Condition Lower Respiratory Tract Illness
Treatment Placebo, RSVpreF
Clinical Study IdentifierNCT05035212
SponsorPfizer
Last Modified on22 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, frequent symptom assessment by mobile device application, and other study procedures, including collection of nasal swabs by themselves and by study staff when indicated
Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study
Note: Healthy participants with preexisting stable disease, defined as disease
not requiring significant change in therapy or hospitalization for worsening
disease during the 6 weeks before enrollment, can be included. Specific
criteria for participants with known stable infection with HIV, HCV, or HBV
can be found in the protocol
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
Male or female participants ≥60 years of age
Male participants able to father children must agree to use a highly effective method of contraception from the time of informed consent through at least 28 days after study intervention administration
Female participants must not be of childbearing potential

Exclusion Criteria

Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection
Participation in other studies involving an investigational product within 28 days prior to consent and/or through and including the 6-months follow-up visit (Visit 3)
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
Note: This criterion does not apply to participants who are participating in a
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
follow-up period for another study involving a study intervention that is an
Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination
investigational drug or vaccine, if receipt of the last dose was at least 12
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
months prior to consenting for this study and there is no further dosing
anticipated from the previous study during the participant's participation in
this study
Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled in the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted
Note: Participants with COPD or asthma can be enrolled if chronic
corticosteroids do not exceed a dose equivalent to 10 mg/day of prednisone
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
Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members
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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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