Recruiting

Observational Study

Sponsor:

CorEvitas

Code:

NCT06521944

Conditions

Respiratory Syncytial Virus (RSV)

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

RSV Vaccine

Non-exposure to RSV Vaccine

Study Details

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.

Conditions

Respiratory Syncytial Virus (RSV)

Study ID

NCT06521944

Start date

Jun 28, 2024

Status verified date

Jul, 2024

Completion date

Sep 30, 2030

Anticipated

Primary completion date

Sep 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

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

Study Design

Enrollment

2062 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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

Pregnant individuals who are not exposed to the RSV vaccine

Primary outcome measure

  • Risk of preterm birth following RSV vaccine exposure [ Time Frame: 36 weeks, 6 days ]
  • Risk of hypertensive disorders following RSV vaccine exposure [ Time Frame: 42 days after date of vaccination ]

Central Contacts and Locations

Central contacts

Ronna Chan, PhD, MPH

1-800-616-3791RSV@corevitas.com

Locations

PPD

Recruiting

Wilmington, North Carolina, United States, 28401

Contacts

CorEvitas Clinical Research Associate

800-616-3791RSV@corevitas.com

More Information

Sponsor

CorEvitas

Last update posted

Jul 26, 2024

Last verified

Jul, 2024

Keywords

  • Pregnant
  • Registry
  • RSV
  • RSV Vaccine
  • Respiratory Syncytial Virus
  • Infections
  • Virus Diseases
  • Lung Diseases
  • Respiratory Tract Diseases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-21. This information was provided to ClinicalTrials.gov by CorEvitas on 2024-07-26.