Status:
RECRUITING
RSV Vaccine Pregnancy Registry
Lead Sponsor:
CorEvitas
Conditions:
Respiratory Syncytial Virus (RSV)
Eligibility:
FEMALE
18-50 years
Brief Summary
The research question is: What is the risk of adverse pregnancy outcomes, including preterm birth, hypertensive disorders, and other maternal and neonatal/infant outcomes, following exposure to RSV va...
Detailed Description
Rationale and background: Respiratory syncytial virus (RSV) vaccine is approved for use in pregnant individuals during late pregnancy (32 weeks, 0 days through 36 weeks, 6 days of gestation) to preven...
Eligibility Criteria
Inclusion
- Individuals must meet the following inclusion criteria to be eligible for inclusion in the study:
- A resident of the US at enrollment
- 18 to 50 years of age at enrollment
- Gestational age of ≥32 weeks, 0 days at enrollment
- If exposed to RSV vaccine, receipt of any RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation
- Evidence of a personally signed and dated informed consent document or, upon waiver of written consent by the relevant IRB/independent ethics committee, verbal consent indicating that the individual (or a legally acceptable representative) has been informed of all pertinent aspects of the study
- Authorization obtained for the relevant HCP(s) to provide data to the registry
- Contact information available (for participant and HCPs)
Exclusion
- Individuals meeting any of the following criteria will not be included in the study:
- Receipt of an RSV vaccine during pregnancy before 32 weeks, 0 days gestation
- Multi-fetal pregnancy
- Enrolled in the RSV-PR with a previous pregnancy
Key Trial Info
Start Date :
June 28 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2030
Estimated Enrollment :
2062 Patients enrolled
Trial Details
Trial ID
NCT06521944
Start Date
June 28 2024
End Date
September 30 2030
Last Update
July 26 2024
Active Locations (1)
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1
PPD
Wilmington, North Carolina, United States, 28401