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 @ 12:35 PM
Ignite Modification Date:
2025-12-24 @ 12:35 PM
NCT ID:
NCT07122661
Eligibility Criteria:
Inclusion Criteria:
Participants must meet all of the following inclusion criteria to be eligible for inclusion in the study:
1. Infant ≤12 months (≤360 days) of age on the hospitalisation date.
2. Index date within the time period for data collection (approximately 01 March 2025 - 28 February 2027)
3. Hospitalised with acute respiratory illness meeting the protocol-defined clinical case definition, and for whom RSV testing results from a specimen collected 10 days prior to hospital admission through 3 days after a hospital admission are known.
4. Infant born to a birth mother eligible to receive ABRYSVO vaccination, with infant date of birth on or after 17 February 2025.
Exclusion Criteria:
Participants meeting any of the following criteria will not be included in the study:
1. Infant born at \<28 weeks and 0/7 days of gestational age.
2. Infant received any licensed or investigational RSV preventive product (e.g., palivizumab, nirsevimab, active RSV vaccine) since birth.
3. Infant received ≥1 blood transfusion or other blood products containing antibody (e.g., fresh frozen plasma) since birth.
4. Infant born to a birth mother who received any other licensed or investigational RSV vaccine during this pregnancy.
5. Infant born to a birth mother for whom ABRYSVO vaccination status cannot be confirmed in available data sources.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
12 Months
Study:
NCT07122661
Study Brief:
Protocol Section:
NCT07122661