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:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
NCT ID:
NCT06551506
Eligibility Criteria:
Inclusion Criteria:
1. 18-45 years of age at time of enrollment with an uncomplicated singleton pregnancy who are at no known increased risk for complications per clinical judgement of the investigator
2. Understands and agrees to comply with all study procedures
3. Willing and able to provide consent for study participation for themselves and their infant prior to initiation of any study procedures
4. In good health, as determined by the medical history and clinical judgment of the investigator Note: Healthy volunteers with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.
5. Intention to deliver at a hospital or birthing facility where study procedures can be performed
6. Eligible to receive either product per the FDA package inserts. (Maternal RSVpreF from 32 0/7 to 36 6/7 weeks gestational age (GA) from September 1 to March 31)
Exclusion Criteria:
1. Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the study
2. Any condition which, in the opinion of the investigators, may pose a health risk for the participant or interfere with the evaluation of study objectives
3. Maternal bleeding diathesis, or any condition which may contraindicate intramuscular injection
4. Maternal known or suspected congenital or acquired disease that impairs the immune system, including functional asplenia or immunosuppression due to underlying illness or treatment
5. Maternal receipt of immunosuppressive drugs or biologic agents within 30 days prior to enrollment (This includes oral or parenteral corticosteroids. The use of inhaled/nebulized, intra-articular, intrabursal, or topical (skin, eye, ears) steroids are permitted. This does not include RhoGAM)
6. Maternal conditions known to impair transplacental transfer of maternal antibodies (e.g., placental pathology, hypergammaglobulinemia, HIV)
7. Maternal history of GBS or other potentially immune-mediated medical condition (PIMMC)
8. Maternal history of severe adverse reaction or anaphylaxis to ABRYSVO or its components
9. Maternal history of preterm birth (\<34 weeks GA)
10. Current pregnancy complicated by uncontrolled hypertension, pre-eclampsia, or eclampsia
11. Previous receipt of ABRYSVO or other approved or investigational RSV vaccine
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06551506
Study Brief:
Protocol Section:
NCT06551506