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 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT07249320
Eligibility Criteria:
Inclusion Criteria
Pregnant Individuals - Inclusion Criteria:
Participants must meet all of the following inclusion criteria to be eligible for inclusion in the study:
1. Gestational age at delivery ≥32 0/7 weeks of gestation (earliest gestational age eligible for ABRYSVO vaccination) during the study period
2. Maternal age 18 to 50 years at pregnancy onset
3. At least 1 prenatal visit between pregnancy onset and 20 weeks of gestation
4. Continuous KPNC enrollment for a minimum of 30 days prior to pregnancy onset through to the date of delivery, with no more than a 1-month administrative gap in coverage
Infants - Inclusion Criteria:
Participants must meet all of the following inclusion criteria to be eligible for inclusion in the study:
1. Born to a pregnant individual who has met all inclusion and exclusion criteria outlined above
2. Live birth
3. Enrolled as member in KPNC by 3 months of age
Exclusion Criteria
Pregnant Individuals - Exclusion Criteria:
Participants meeting any of the following criteria will not be included in the study:
1. Received any licensed or investigational RSV vaccine other than ABRYSVO at any time during pregnancy
2. Received ABRYSVO at ≥37 weeks' gestation
3. Received ABRYSVO at \<32 0/7 weeks' gestation
Infants - Exclusion Criteria:
There are no exclusion criteria for infants. Those who receive any licensed or investigational RSV preventative product (e.g., monoclonal antibodies) at/after birth or any licensed or investigational RSV therapeutic (e.g., antiviral medications) will not be excluded, but their follow-up time will be censored on the date of receipt of the RSV preventative or therapeutic product.
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
50 Years
Study:
NCT07249320
Study Brief:
Protocol Section:
NCT07249320