Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521944
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
RSV Vaccine Pregnancy Registry
Sponsor:
None
Organization:
None
Study Overview
Official Title:
CorEvitas RSV Vaccine Pregnancy Registry RSV-PR
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RSV-PR
Brief Summary:
The research question is What is the risk of adverse pregnancy outcomes including preterm birth hypertensive disorders and other maternal and neonatalinfant 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
Neonatalinfant 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
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
Neonatalinfant 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
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 neonatalinfant 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
Neonatalinfant 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 ie 32 weeks 0 days through 36 weeks 6 days and the risk of subsequent pregnancy maternal and neonatalinfant 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 neonatalinfant 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 neonatalinfant 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 2062total participants 1031 per cohort to detect a minimum risk ratio of 15 or greater for the primary outcome of preterm birth fewer participants are required to detect hypertensive disorders of pregnancy assuming equal accrual 11 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 ie 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
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 neonatalinfant 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
Neonatalinfant 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 ie 32 weeks 0 days through 36 weeks 6 days and the risk of subsequent pregnancy maternal and neonatalinfant 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 neonatalinfant 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 neonatalinfant 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 2062total participants 1031 per cohort to detect a minimum risk ratio of 15 or greater for the primary outcome of preterm birth fewer participants are required to detect hypertensive disorders of pregnancy assuming equal accrual 11 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None