RSV Vaccine Pregnancy Registry
RSV-PR
CorEvitas RSV Vaccine Pregnancy Registry (RSV-PR)
1 other identifier
observational
2,062
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 28, 2024
CompletedFirst Submitted
Initial submission to the registry
July 16, 2024
CompletedFirst Posted
Study publicly available on registry
July 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2030
July 26, 2024
July 1, 2024
6.3 years
July 16, 2024
July 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Risk of preterm birth following RSV vaccine exposure
Risk of preterm birth following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation
36 weeks, 6 days
Risk of hypertensive disorders following RSV vaccine exposure
Risk of hypertensive disorders following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation
42 days after date of vaccination
Secondary Outcomes (21)
Risk of other safety outcomes of interest following RSV vaccine exposure
42 days after date of vaccination
Risk of other safety outcomes of interest following RSV vaccine exposure
42 days after date of vaccination
Risk of other safety outcomes of interest following RSV vaccine exposure
42 days after date of vaccination
Risk of other safety outcomes of interest following RSV vaccine exposure
42 days after date of vaccination
Risk of other safety outcomes of interest following RSV vaccine exposure
42 days after date of vaccination
- +16 more secondary outcomes
Study Arms (2)
Exposed
Participants who receive RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation
Unexposed
Participants who do not receive RSV vaccine during pregnancy
Interventions
RSV Vaccine approved for administration to pregnant individuals between 32 weeks, 0 days and 36 weeks, 6 days of gestation
Pregnant individuals who are not exposed to the RSV vaccine
Eligibility Criteria
Pregnant individuals across the US who learn of the study via a nationwide advertising campaign or via their health care providers or maternal care sites
You may qualify if:
- A resident of the US at enrollment
- to 50 years of age at enrollment
- Gestational age of ≥32 weeks, 0 days at enrollment
- If exposed to RSV vaccine, receipt of any RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation
- 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
- Authorization obtained for the relevant HCP(s) to provide data to the registry
- Contact information available (for participant and HCPs)
You may not qualify if:
- Individuals meeting any of the following criteria will not be included in the study:
- Receipt of an RSV vaccine during pregnancy before 32 weeks, 0 days gestation
- Multi-fetal pregnancy
- Enrolled in the RSV-PR with a previous pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CorEvitaslead
Study Sites (1)
PPD
Wilmington, North Carolina, 28401, United States
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronna Chan, PhD, MPH
PPD, Part of Thermo Fisher Scientific
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2024
First Posted
July 26, 2024
Study Start
June 28, 2024
Primary Completion (Estimated)
September 30, 2030
Study Completion (Estimated)
September 30, 2030
Last Updated
July 26, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share