Respiratory Syncytial Virus (RSV)

Last updated: April 18, 2022
Sponsor: Janssen Vaccines & Prevention B.V.
Overall Status: Active - Recruiting

Phase

3

Condition

Vaccines

Treatment

N/A

Clinical Study ID

TX290579
VAC18193RSV 3001
  • Ages 60-100
  • All Genders

Study Summary

The study will enroll up to 23000 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • .60 Years and Older
  • 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

Exclusion

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 or revaccination not in the following categories: a. 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
  • Had major surgery (example, major cardiopulmonary or abdominal operations) as per the investigator's judgment within 4 weeks before vaccination, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study
  • Contraindication to Intramuscular (IM) injections and blood draws (example, bleeding disorders)
  • 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)

Study Design

Study Start date:
January 13, 2022
Estimated Completion Date:

Study Description

  • Condition: Respiratory Syncytial Virus (RSV)
  • Clinical Trial Identifier: NCT04908683
  • Sponsor: Janssen Vaccines & Prevention B.V.

Looking for participants within a 50 mile radius of the study site.

Connect with a study center

  • Coastal Clinical Research, Inc.

    Mobile, Alabama 36608
    United States

    Active - Recruiting

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