EICHORCondition: Respiratory Syncytial Virus (RSV) · Sponsor: CorEvitas
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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 va…
This description comes directly from the study's public registry record.
Ronna Chan, PhD, MPH · 1-800-616-3791 · RSV@corevitas.com
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Inclusion Criteria: * Individuals must meet the following inclusion criteria to be eligible for inclusion in the study: 1. A resident of the US at enrollment 2. 18 to 50 years of age at enrollment 3. Gestational age of ≥32 weeks, 0 days at enrollment 4. If exposed to RSV vaccine, receipt of any RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation 5. 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 6. Authorization obtained for the relevant HCP(s) to provide data to the registry 7. Contact information available (for participant and HCPs) Exclusion Criteria: * Individuals meeting any of the following criteria will not be included in the study: 1. Receipt of an RSV vaccine during pregnancy before 32 weeks, 0 days gestation 2. Multi-fetal pregnancy 3. Enrolled in the RSV-PR with a previous pregnancy
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| PPD | Wilmington, North Carolina, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06521944