RSV Vaccine Pregnancy Registry
NCT Number: NCT06521944
Acronym: RSV-PR
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Respiratory Syncytial Virus (RSV)
Interventions: BIOLOGICAL: RSV Vaccine|OTHER: Non-exposure to RSV Vaccine
Sponsor: CorEvitas
Sex: FEMALE
Age: ADULT
Enrollment: 2062
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-28
Completion Date: 2030-09-30
Locations: PPD, Wilmington, North Carolina, 28401, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Risk of other safety outcomes of interest following RSV vaccine exposure, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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