A Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of an Ad26.RSV.preF-based Vaccine in the Prevention of Lower Respiratory Tract Disease Caused by RSV in Adults Aged 60 Years and Older (EVERGREEN)

  • STATUS
    Recruiting
  • End date
    Oct 23, 2023
  • participants needed
    27500
  • sponsor
    Janssen Vaccines & Prevention B.V.
Updated on 17 September 2022
Accepts healthy volunteers

Summary

The study will enroll up to 27,500 participants in order to demonstrate the efficacy of the active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower Respiratory Tract Disease (LRTD) when compared to placebo in adults aged 60 years and above.

Details
Condition Respiratory Syncytial Viruses, Lower Respiratory Tract Disease
Treatment Placebo, Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF
Clinical Study IdentifierNCT04908683
SponsorJanssen Vaccines & Prevention B.V.
Last Modified on17 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Must be able to work with smartphones/tablets/computers
From the time of vaccination through 3 months after vaccination, participant agrees not to donate blood
Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
Before randomization, a participant must be: a. postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and b. not intending to conceive by any methods
Participants must sign an Inform Consent Form (ICF) indicating that the participant understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study

Exclusion Criteria

Has a serious clinically unstable condition, (example, end-stage renal disease with or without dialysis, clinically unstable cardiac disease), Alzheimer's disease, or any other condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise well-being) or that could prevent, confound, or limit the protocol specified assessments
History of malignancy within 5 years before screening not in the following categories
Participants with squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix may be enrolled at the discretion of the investigator; b. Participants with a history of malignancy within 5 years, which is considered cured with minimal risk of recurrence per investigator's judgement, can be enrolled
Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator, or an employee of the sponsor
Had major surgery (example, major cardiopulmonary or abdominal operations) as per the
Contraindication to Intramuscular (IM) injections and blood draws (example, bleeding disorders)
investigator's judgment within 4 weeks before vaccination, or will not have
Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine)
fully recovered from surgery, or has major surgery planned during the time the
participant is expected to participate in the study
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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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