Actively Recruiting
CorEvitas RSV Vaccine Pregnancy Registry (RSV-PR) to Assess Pregnancy and Infant Outcomes After RSV Vaccine Exposure in Late Pregnancy
Led by CorEvitas · Updated on 2024-07-26
2062
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand the risk of adverse pregnancy outcomes following exposure to the Respiratory Syncytial Virus (RSV) vaccine during late pregnancy, specifically between 32 weeks, 0 days and 36 weeks, 6 days of gestation. The study focuses on estimating the risk of preterm birth and hypertensive disorders of pregnancy as the primary objectives. It also examines a range of secondary maternal, pregnancy-related, and neonatal/infant outcomes, including stillbirth, premature labor, cesarean delivery, maternal complications, and infant health measures up to 1 year of age. Participants are divided into two groups: those who receive the RSV vaccine during the specified gestational period and those who do not receive the vaccine during pregnancy. The study collects data from both groups through the CorEvitas Respiratory Syncytial Virus Vaccine Pregnancy Registry. Information is gathered via healthcare providers and participants at set times during pregnancy, at delivery, and during infant follow-up to track health outcomes and adverse events. Throughout the study, participants will provide data on pregnancy progress, maternal health, and infant development up to one year after birth. Researchers will use this data to assess the frequency and risk of various outcomes, including preterm birth, hypertensive disorders, and other complications. Safety monitoring includes capturing maternal adverse events occurring within 42 days after vaccination. The study is observational and plans to enroll approximately 2,062 participants, following them from enrollment until infant age of one year, with data collection ending in 2030 and final analysis in 2031.
CONDITIONS
Brief Title
RSV Vaccine Pregnancy Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be a resident of the US at enrollment
- Female aged 18 to 50 years at enrollment
- Pregnant with a gestational age of at least 32 weeks, 0 days at enrollment
- If exposed, receipt of any RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation
- Provided signed informed consent or verbal consent if approved by ethics committee
- Authorized healthcare provider(s) to share data with the registry
- Contact information available for participant and healthcare providers
You will not qualify if you...
- Received RSV vaccine during pregnancy before 32 weeks, 0 days gestation
- Pregnant with multiple fetuses (multi-fetal pregnancy)
- Previously enrolled in the RSV-PR with a prior pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From 32 weeks, 0 days through delivery
Participants who are pregnant with a gestational age of at least 32 weeks, 0 days are observed during late pregnancy. Participants may be exposed to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation or remain unexposed.
Data collected at enrollment and pregnancy outcome
Duration - Up to 1 year after birth
Participants and their infants are followed to assess maternal and neonatal outcomes, including adverse events up to 42 days after vaccination and infant growth up to 1 year of age.
Data collected at pregnancy outcome and periodic follow-up visits up to 1 year for infant assessment
Trial Site Locations
Total: 1 location
1
PPD
Wilmington, North Carolina, United States, 28401
Actively Recruiting
Research Team
R
Ronna Chan, PhD, MPH
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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