Last updated: 05/28/2026 08:20:08
A Cohort Study to Assess Pregnancy and Birth Outcomes Study After Exposure to PENMENVY Vaccine in the US
GSK study ID
300300
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Planned
Planned
Trial overview
Official title: A Pregnancy and Birth Outcomes Study After Exposure to PENMENVY Vaccine in the US: A Cohort Study
Trial description: The aim of this study is to assess the safety of PENMENVY during pregnancy using information from 2 administrative healthcare claims databases (MarketScan and Medicaid) in the U.S.; specifically, to assess whether exposure to PENMENVY during specific gestational periods is associated with an increased risk of pre-specified pregnancy and birth outcomes.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Estimated risk of pregnancy outcomes (live birth, stillbirth, and spontaneous abortion) in pregnant women exposed to PENMENVY compared to unexposed pregnant women
Timeframe: From 2025 to 2031 (MarketScan data) and from 2025 to 2029 (Medicaid data)
Estimated risk of birth outcomes [major congenital malformations (MCMs), preterm birth, and small for gestational age] among infants exposed to PENMENVY in utero compared to unexposed infants
Timeframe: From 2025 to 2031 (MarketScan data) and from 2025 to 2029 (Medicaid data)
Secondary outcomes:
Estimated risk of pregnancy (live birth, stillbirth, spontaneous abortion) and birth outcomes (MCMs, preterm birth, small for gestational age) in pregnant women exposed to the PENMENVY vaccine compared to pregnant women exposed to the influenza vaccine
Timeframe: From 2025 to 2031 (MarketScan data) and from 2025 to 2029 (Medicaid data)
Interventions:
Not applicable
Enrollment:
Not applicable
Observational study model:
Cohort
Primary completion date:
2032-31-08
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Infections, Bacterial
Product
Not applicable
Collaborators
Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, US, Harvard T.H. Chan School of Public Health
Study date(s)
May 2026 to August 2032
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
10 - 55 Years
Accepts healthy volunteers
Yes
- The study cohort will include pregnant women with or without PENMENVY exposure during the etiologically relevant window. Pregnancy is identified based on end of pregnancy codes (e.g., spontaneous abortion or delivery) and other pregnancy markers (e.g., first trimester ultrasound).
- For the analyses of pregnancy outcomes, the cohort will include pregnancies ending in stillbirth, spontaneous abortion, or live birth (linked or unlinked to a liveborn infant).
- For birth outcomes, pregnancies ending in non-live births will be excluded (since congenital malformations are rarely coded among these, and non-live births will not be at risk for other birth outcomes).
- For MCMs, pregnancies with a chromosomal abnormality based on at least 1 inpatient or outpatient code within 90 days after delivery present in the infant and/or maternal claims will be excluded, as the cause of the outcomes of interest in these pregnancies is unlikely to be related to PENMENVY exposure.
Inclusion and exclusion criteria
Inclusion criteria:
- For the analyses of pregnancy outcomes, the cohort will include pregnancies ending in stillbirth, spontaneous abortion, or live birth (linked or unlinked to a liveborn infant).
- For birth outcomes, the cohort will be restricted to pregnancies with linked liveborn infants. For MCMs, only pregnancies ending in live birth will be included since information regarding the pathology results from a pregnancy loss or the indication for termination is rarely recorded. However, data on non-live births will be used to inform sensitivity analyses examining the potential impact of differences in the proportion of non-live births among women exposed versus not exposed with PENMENVY.
- In sensitivity analyses, given the indication to use PENMENVY specifically in individuals 10 through 25 years of age, the cohorts will be restricted to pregnant women within the indicated age range.
The study cohort will include pregnant women with or without PENMENVY exposure during the etiologically relevant window. Pregnancy is identified based on end of pregnancy codes (e.g., spontaneous abortion or delivery) and other pregnancy markers (e.g., first trimester ultrasound).
Exclusion criteria:
- For MCMs, pregnancies with a chromosomal abnormality based on at least 1 inpatient or outpatient code within 90 days after delivery present in the infant and/or maternal claims will be excluded, as the cause of the outcomes of interest in these pregnancies is unlikely to be related to PENMENVY exposure.
- Pregnancies with >=1 prescription dispensing of a definite teratogenic medication within 3 months prior to the exposure assessment period will be excluded, as these medications present a known increased risk of adverse pregnancy or birth outcomes.
- Pregnancies ending in ectopic pregnancy, molar pregnancy, or induced abortion are excluded by design. Validated pregnancy identification algorithm, previously published by Harvard Program on Perinatal and Pediatric Pharmacoepidemiology (H4P) team, is based on the end of pregnancy type and the study cohort will be restricted to spontaneous abortions, stillbirths, and live births.
For birth outcomes, pregnancies ending in non-live births will be excluded (since congenital malformations are rarely coded among these, and non-live births will not be at risk for other birth outcomes).
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Planned
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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