Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT04453202
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT04453202
Study Brief:
Protocol Section:
NCT04453202