RSV Vaccine Pregnancy Registry
ConditionRespiratory Syncytial Virus (RSV)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorCorEvitas
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
A resident of the US at enrollment
18 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
Disqualifiers
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
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
RSV Vaccine
Biological/VaccineRSV Vaccine approved for administration to pregnant individuals between 32 weeks, 0 days and 36 weeks, 6 days of gestation
Non-exposure to RSV Vaccine
Other interventionPregnant individuals who are not exposed to the RSV vaccine
Treatment groups
2,062 Participants
are divided into 2 treatment groupsGroup A: Exposed1 intervention
Group B: Unexposed1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
36 weeks, 6 days2
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
Time frame
42 days after date of vaccinationSecondary outcomes
1
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
Time frame
42 days after date of vaccination2
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
Time frame
42 days after date of vaccination3
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
Time frame
42 days after date of vaccination4
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
Time frame
42 days after date of vaccination Source ClinicalTrials.gov