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RSV Vaccine Pregnancy Registry

NCT06521944 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2062

Last updated 2024-07-26

No results posted yet for this study

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)

Interventions

BIOLOGICAL

RSV Vaccine

RSV Vaccine approved for administration to pregnant individuals between 32 weeks, 0 days and 36 weeks, 6 days of gestation

OTHER

Non-exposure to RSV Vaccine

Pregnant individuals who are not exposed to the RSV vaccine

Sponsors & Collaborators

  • CorEvitas

    lead NETWORK

Principal Investigators

  • Ronna Chan, PhD, MPH · PPD, Part of Thermo Fisher Scientific

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-28
Primary Completion
2030-09-30
Completion
2030-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06521944 on ClinicalTrials.gov