RSV Vaccine Pregnancy Registry

Recruiting now

Conditions studied: Respiratory Syncytial Virus (RSV)

In brief

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 vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation in the CorEvitas Respiratory Syncytial Virus Vaccine Pregnancy Registry (RSV-PR)? The primary study objective is to estimate the risk of (1) preterm birth and (2) hypertensive disorders following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation. The secondary study objective is to estimate the risk of other safety outcomes of interest following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including: * Pregnancy-related outcomes: stillbirth, premature labor, premature rupture of membranes, preterm premature rupture of membranes, cesarean delivery, prolonged maternal duration of hospital stay * Maternal outcomes: thrombocytopenia, Guillain-Barré syndrome, other immune-mediated demyelinating conditions, polyneuropathies, atrial fibrillation, maternal death * Neonatal/infant outcomes: small for gestational age, large for gestational age, low birth weight, admission to a neonatal intensive care unit (NICU), NICU duration of stay, mechanical ventilation in neonatal period, neonatal death, postnatal growth at 1 year of age The exploratory study objective is to describe the most frequently reported maternal adverse events following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation.

Key facts

Study ID

NCT06521944

Run by

CorEvitas

People needed

2062

Starts

2024-06-28

Expected to finish

2030-09-30

Last updated by the study team

2024-07-26

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• PPD — Wilmington, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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