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:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-24 @ 7:04 PM
NCT ID:
NCT06060457
Eligibility Criteria:
Key Inclusion Criteria:
* Participants may have one or more chronic medical diagnoses, but should be medically stable as assessed by:
* Absence of changes in medical therapy within 60 days of Day 1 due to treatment failure or toxicity,
* Absence of serious or significant medical events within 30 days of Day 1, and
* Absence of known, current, and life-limiting diagnoses which, in the opinion of the Investigator, would make completion of the protocol unlikely.
* A participant assigned female at birth is eligible to participate if they are postmenopausal or not a person of childbearing potential.
Key Exclusion Criteria:
* Close contact with someone with laboratory-confirmed influenza and/or RSV infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®) within the past 5 days prior to Day 1.
* Reported history of congenital or acquired immunodeficiency, immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections.
* Participant has tested positive for influenza or RSV by local health authority-approved testing methods ≤6 months prior to Day 1.
* Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study injections (Day 1 and Day 22) or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study injections.
* Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine ≤6 months prior to Day 1.
* Participant has received any RSV vaccine (authorized/approved by local health agency or investigational) prior to Day 1.
Note: Other protocol-defined inclusion and/or exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT06060457
Study Brief:
Protocol Section:
NCT06060457