RecruitingNCT06521944

RSV Vaccine Pregnancy Registry

CorEvitas RSV Vaccine Pregnancy Registry (RSV-PR)


Sponsor

CorEvitas

Enrollment

2,062 participants

Start Date

Jun 28, 2024

Study Type

OBSERVATIONAL

Conditions

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 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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria7

  • 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 Criteria4

  • 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

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Interventions

BIOLOGICALRSV Vaccine

RSV Vaccine approved for administration to pregnant individuals between 32 weeks, 0 days and 36 weeks, 6 days of gestation

OTHERNon-exposure to RSV Vaccine

Pregnant individuals who are not exposed to the RSV vaccine


Locations(1)

PPD

Wilmington, North Carolina, United States

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NCT06521944


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