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

First listed

Jul 26, 2024

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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