RSV Vaccine Pregnancy Registry (RSV-PR)

July 23, 2024 updated by: CorEvitas

CorEvitas RSV Vaccine Pregnancy Registry (RSV-PR)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Rationale and background: Respiratory syncytial virus (RSV) vaccine is approved for use in pregnant individuals during late pregnancy (32 weeks, 0 days through 36 weeks, 6 days of gestation) to prevent RSV-related severe lower respiratory tract disease in infants from birth through 6 months of age.

Research question and objectives: This work is intended to answer the question regarding 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? The primary study objective is to estimate the risk of (1) preterm birth and (2) hypertensive disorders of pregnancy 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 (PROM), preterm premature rupture of membranes (PPROM), cesarean delivery, prolonged maternal duration of hospital stay
  • Maternal outcomes: thrombocytopenia, Guillain-Barré syndrome (GBS), other immune-mediated demyelinating conditions, polyneuropathies, atrial fibrillation, maternal death
  • Neonatal/infant outcomes: small for gestational age (SGA), large for gestational age, low birth weight (LBW), admission to a neonatal intensive care unit (NICU), NICU duration of stay, mechanical ventilation in neonatal period, neonatal death, postnatal growth deficiency at 1 year of age The exploratory study objective is to describe the most frequently reported maternal adverse events (AEs) occurring within 42 days of RSV vaccine administration between 32 weeks, 0 days and 36 weeks, 6 days of gestation.

Outcomes occurring before 32 weeks, 0 days of gestation, including but not limited to spontaneous abortion and major congenital malformations, will not be evaluated.

Study design: This US-based observational cohort study is designed to evaluate RSV vaccine exposure during weeks 32 through 36 of pregnancy (i.e., 32 weeks, 0 days through 36 weeks, 6 days) and the risk of subsequent pregnancy, maternal, and neonatal/infant outcomes. For this study, the index date will be the date of RSV vaccine administration for the exposed cohort and the date of enrollment for the unexposed cohort. The risks of pregnancy-related outcomes, maternal outcomes, and neonatal/infant outcomes for participants exposed and unexposed to RSV vaccine during pregnancy will be estimated.

Population: The study population will include 2 cohorts of individuals enrolled in the Respiratory Syncytial Virus Vaccine Pregnancy Registry (RSV-PR): (1) those exposed to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days and (2) those unexposed to RSV vaccine during pregnancy.

Variables: Exposure to RSV vaccine will be defined as receipt of RSV vaccine at any time between 32 weeks, 0 days and 36 weeks, 6 days of gestation. The primary outcomes are preterm birth and hypertensive disorders of pregnancy. Secondary pregnancy outcomes of interest include stillbirth, premature labor, PROM, PPROM, cesarean delivery, and prolonged maternal duration of hospital stay. Maternal outcomes of interest include thrombocytopenia, GBS, other immune-mediated demyelinating conditions, polyneuropathies, atrial fibrillation, and maternal death. The neonatal/infant outcomes of interest are SGA, large for gestational age, LBW, admission to a NICU, prolonged infant duration of hospital stay, mechanical ventilation in neonatal period, neonatal death, and postnatal growth deficiency at 1 year of age. Maternal AEs occurring within 42 days of RSV vaccine administration will be captured for the cohort of RSV vaccine-exposed pregnant individuals.

Information on covariates (including demographics, risk factors for the study outcomes, comorbidities, concomitant medications, and predictors of RSV vaccine use) will be incorporated into the analyses.

Data source: This study will collect data from participants and the healthcare providers (HCPs) involved in their care or the care of their infants via concise data collection forms at pre-defined timepoints during pregnancy, at pregnancy outcome, and up to 1 year of infant age.

Study Size: The study will aim to include 2,062total participants (1,031 per cohort) to detect a minimum risk ratio of 1.5 or greater for the primary outcome of preterm birth (fewer participants are required to detect hypertensive disorders of pregnancy), assuming equal accrual (1:1) of RSV vaccine-exposed and -unexposed participants, and accounting for exclusions from the analysis population and loss of effective sample size due to inverse probability of treatment weighting.

Data analysis: Participant characteristics will be summarized with descriptive statistics for each cohort. Comparative analyses will be conducted for each outcome if sample size permits. Supplementary analyses will be conducted that include pregnant individuals who were excluded from the analysis population (i.e., those lacking HCP confirmation of RSV vaccine exposure, pregnancy, or outcomes of interest). If sample size permits, subgroup and sensitivity analyses will be performed to examine the extent to which changes in certain methods or assumptions affect the results.

Milestones: Start of data collection is planned for 30 September 2024, and the end of data collection is planned for 30 September 2030. The final study report and analysis is projected for 30 September 2031.

Study Type

Observational

Enrollment (Estimated)

2062

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Recruiting
        • PPD
        • Contact:
          • CorEvitas Clinical Research Associate
          • Phone Number: 800-616-3791
          • Email: RSV@corevitas.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exposed
Participants who receive RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation
Biological: RSV Vaccine
RSV Vaccine approved for administration to pregnant individuals between 32 weeks, 0 days and 36 weeks, 6 days of gestation
Unexposed
Participants who do not receive RSV vaccine during pregnancy
Other: Non-exposure to RSV Vaccine
Pregnant individuals who are not exposed to the RSV vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of preterm birth following RSV vaccine exposure
Time Frame: 36 weeks, 6 days
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
Time Frame: 42 days after date of vaccination
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of other safety outcomes of interest following RSV vaccine exposure
Time Frame: 42 days after date of vaccination
The risk of other safety outcomes of interest following exposure to RSV vaccine as per routine clinical practice between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including Pregnancy-related outcome: stillbirth
42 days after date of vaccination
Risk of other safety outcomes of interest following RSV vaccine exposure
Time Frame: 42 days after date of vaccination
The risk of other safety outcomes of interest following exposure to RSV vaccine as per routine clinical practice between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including Pregnancy-related outcome: premature labour
42 days after date of vaccination
Risk of other safety outcomes of interest following RSV vaccine exposure
Time Frame: 42 days after date of vaccination
The risk of other safety outcomes of interest following exposure to RSV vaccine as per routine clinical practice between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including Pregnancy-related outcome: premature rupture of membranes
42 days after date of vaccination
Risk of other safety outcomes of interest following RSV vaccine exposure
Time Frame: 42 days after date of vaccination
The risk of other safety outcomes of interest following exposure to RSV vaccine as per routine clinical practice between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including Pregnancy-related outcome: preterm premature rupture of membranes
42 days after date of vaccination
Risk of other safety outcomes of interest following RSV vaccine exposure
Time Frame: 42 days after date of vaccination
The risk of other safety outcomes of interest following exposure to RSV vaccine as per routine clinical practice between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including Pregnancy-related outcome: cesarean delivery
42 days after date of vaccination
Risk of other safety outcomes of interest following RSV vaccine exposure
Time Frame: 42 days after date of vaccination
The risk of other safety outcomes of interest following exposure to RSV vaccine as per routine clinical practice between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including Pregnancy-related outcome: prolonged maternal duration of hospital stay
42 days after date of vaccination
Risk of other safety outcomes of interest following RSV vaccine exposure
Time Frame: 42 days after date of vaccination
The risk of other safety outcomes of interest following exposure to RSV vaccine as per routine clinical practice between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including Maternal outcome: thrombocytopenia
42 days after date of vaccination
Risk of other safety outcomes of interest following RSV vaccine exposure
Time Frame: 42 days after date of vaccination
The risk of other safety outcomes of interest following exposure to RSV vaccine as per routine clinical practice between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including Maternal outcome: Guillain-Barré syndrome
42 days after date of vaccination
Risk of other safety outcomes of interest following RSV vaccine exposure
Time Frame: 42 days after date of vaccination
The risk of other safety outcomes of interest following exposure to RSV vaccine as per routine clinical practice between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including Maternal outcome: other immune-mediated demyelinating conditions
42 days after date of vaccination
Risk of other safety outcomes of interest following RSV vaccine exposure
Time Frame: 42 days after date of vaccination
The risk of other safety outcomes of interest following exposure to RSV vaccine as per routine clinical practice between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including Maternal outcome: polyneuropathies
42 days after date of vaccination
Risk of other safety outcomes of interest following RSV vaccine exposure
Time Frame: 42 days after date of vaccination
The risk of other safety outcomes of interest following exposure to RSV vaccine as per routine clinical practice between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including Maternal outcome: atrial fibrillation
42 days after date of vaccination
Risk of other safety outcomes of interest following RSV vaccine exposure
Time Frame: 42 days after date of vaccination
The risk of other safety outcomes of interest following exposure to RSV vaccine as per routine clinical practice between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including Maternal outcome: maternal death
42 days after date of vaccination
Risk of other safety outcomes of interest following RSV vaccine exposure
Time Frame: 42 days after date of vaccination
The risk of other safety outcomes of interest following exposure to RSV vaccine as per routine clinical practice between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including Neonatal/infant outcome: small for gestational age
42 days after date of vaccination
Risk of other safety outcomes of interest following RSV vaccine exposure
Time Frame: 42 days after date of vaccination
The risk of other safety outcomes of interest following exposure to RSV vaccine as per routine clinical practice between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including Neonatal/infant outcome: large for gestational age
42 days after date of vaccination
Risk of other safety outcomes of interest following RSV vaccine exposure
Time Frame: 42 days after date of vaccination
The risk of other safety outcomes of interest following exposure to RSV vaccine as per routine clinical practice between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including Neonatal/infant outcome: low birth weight
42 days after date of vaccination
Risk of other safety outcomes of interest following RSV vaccine exposure
Time Frame: 42 days after date of vaccination
The risk of other safety outcomes of interest following exposure to RSV vaccine as per routine clinical practice between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including Neonatal/infant outcome: admission to a neonatal intensive care unit (NICU)
42 days after date of vaccination
Risk of other safety outcomes of interest following RSV vaccine exposure
Time Frame: 42 days after date of vaccination
The risk of other safety outcomes of interest following exposure to RSV vaccine as per routine clinical practice between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including Neonatal/infant outcome: neonatal intensive care unit (NICU) duration of stay
42 days after date of vaccination
Risk of other safety outcomes of interest following RSV vaccine exposure
Time Frame: 42 days after date of vaccination
The risk of other safety outcomes of interest following exposure to RSV vaccine as per routine clinical practice between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including Neonatal/infant outcome: mechanical ventilation in neonatal period
42 days after date of vaccination
Risk of other safety outcomes of interest following RSV vaccine exposure
Time Frame: 42 days after date of vaccination
The risk of other safety outcomes of interest following exposure to RSV vaccine as per routine clinical practice between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including Neonatal/infant outcome: neonatal death
42 days after date of vaccination
Risk of other safety outcomes of interest following RSV vaccine exposure
Time Frame: 42 days after date of vaccination
The risk of other safety outcomes of interest following exposure to RSV vaccine as per routine clinical practice between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including Neonatal/infant outcome: postnatal growth at 1 year of age
42 days after date of vaccination
Frequently reported maternal adverse events following RSV vaccine exposure
Time Frame: 42 days after date of vaccination
The most frequently reported maternal adverse events following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation
42 days after date of vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CorEvitas

Investigators

  • Principal Investigator: Ronna Chan, PhD, MPH, PPD, Part of Thermo Fisher Scientific

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2024

Primary Completion (Estimated)

September 30, 2030

Study Completion (Estimated)

September 30, 2030

Study Registration Dates

First Submitted

July 16, 2024

First Submitted That Met QC Criteria

July 23, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 26, 2024

Last Update Submitted That Met QC Criteria

July 23, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRSV-300

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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