RSV Vaccine Pregnancy Registry

Conditions

• Respiratory Syncytial Virus (RSV)

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 50 Years

Healthy Volunteers

Accepted

Interventions

• RSV Vaccine — BIOLOGICAL
  RSV Vaccine approved for administration to pregnant individuals between 32 weeks, 0 days and 36 weeks, 6 days of gestation
• Non-exposure to RSV Vaccine — OTHER
  Pregnant individuals who are not exposed to the RSV vaccine

Study Details

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 Dates

Start date

Jun 28, 2024

Status verified

Jul 2024

Primary completion

Sep 30, 2030

Completion

Sep 30, 2030

Study Design

Enrollment

2,062 participants (estimated)

Arms

• Arm: Exposed
  Participants who receive RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation
• Arm: Unexposed
  Participants who do not receive RSV vaccine during pregnancy

Primary Outcome Measure

Risk of preterm birth following RSV vaccine exposure [ Time Frame: 36 weeks, 6 days ]

Central Contacts

• Ronna Chan, PhD, MPH
  1-800-616-3791
  [email protected]

Locations (1)

Find similar trials in Wilmington, NC

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