RSV Vaccine Pregnancy Registry (NCT06521944)
CorEvitas RSV Vaccine Pregnancy Registry (RSV-PR)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: PPD — Wilmington, North Carolina
Age range: 18 Years to 50 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- PPD — Wilmington, North Carolina
📞 Contact the Study Coordinator
Phone: (800) 616-3791
Email: RSV@corevitas.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Respiratory Syncytial Virus (RSV)
- Real-World Effectiveness of RSV Vaccines Among Adults Using Target Trial Emulation in Epic Cosmos — New York, New York
- A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV — Jupiter, Florida
- Evaluating ABRYSVO Maternal Vaccine Effectiveness Among Infants — New York, New York
- Systems Biological Analysis of Immune Responses to RSV Vaccine — Decatur, Georgia
- A Study to Learn About Revaccination With a Vaccine Called RSVpreF in Immunocompromised Adults — Rochester, New York
Explore by condition: All Respiratory Syncytial Virus (RSV) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.