Status:
COMPLETED
A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults
Lead Sponsor:
Janssen Vaccines & Prevention B.V.
Conditions:
Healthy
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to explore the dose-response relationship of immune responses induced by different dose levels of an Ad26.RSV.preF based vaccine (Cohort 1) and to assess the safety and re...
Eligibility Criteria
Inclusion
- In the investigator's clinical judgment, participants must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their signs and symptoms are stable and medically controlled in the judgment of the investigator. Participants will be included on the basis of medical history and of physical examination and vital signs performed at screening (all cohorts), and of physical examination and/or vital signs performed prevaccination on Day 1 (Cohorts 2 and 3)
- A woman must be postmenopausal (defined as no menses for 12 months without an alternative medical cause) and not intending to conceive by any methods
- Agree to not donate blood from the time of vaccination until 3 months after vaccination
- Have a body mass index (BMI) less than (\<) 40 kilogram per meter square (kg/m\^2)
- Be willing to provide verifiable identification and have means to be contacted and to contact the investigator during the study
Exclusion
- Has a contraindication to intramuscular injection (IM) injections and blood draws (example, bleeding disorders)
- Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine)
- History of chronic urticaria (recurrent hives), eczema, or atopic dermatitis
- Has hepatitis B or C infection, including history of treated hepatitis C infection
- Received an active RSV vaccine in a previous RSV vaccine study or an Ad26-vectored vaccine at any time prior to randomization
Key Trial Info
Start Date :
July 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2021
Estimated Enrollment :
459 Patients enrolled
Trial Details
Trial ID
NCT04453202
Start Date
July 16 2020
End Date
April 9 2021
Last Update
May 25 2025
Active Locations (9)
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1
Optimal Research
San Diego, California, United States, 92108
2
Clinical Research of South Florida, an AMR Company
Coral Gables, Florida, United States, 33134
3
Heartland Research Associates, an AMR Company
El Dorado, Kansas, United States, 67042
4
Optimal Research
Rockville, Maryland, United States, 20850