Last updated: 11/11/2025 12:10:14
Safety of Herpes Zoster subunit (HZ/su) vaccine during pregnancy in adult women with immunocompromised conditions
GSK study ID
214420
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Ongoing
Ongoing
Trial overview
Official title: Post-marketing commitment safety study of HZ/su to evaluate pregnancy exposures and outcomes in immunodeficient or immunosuppressed women between 18 and 49 years of age
Trial description: The purpose of this post-marketing commitment safety study is to evaluate the real-world safety of HZ/su vaccine during pregnancy in immunodeficient or immunosuppressed adult pregnant women between 18 and 49 years of age in the United States. The primary outcome of interest is major congenital malformations (MCMs).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Prevalence of Major Congenital Malformations (MCMs)
Timeframe: From birth up to 1 year of age
Secondary outcomes:
Prevalence of additional infant/birth outcomes (small for gestational age, low birthweight, neonatal intensive care unit admission)
Timeframe: Within 30 days after the infant’s date of birth
Prevalence of additional infant/birth outcome (preterm birth)
Timeframe: At birth
Prevalence of additional infant/birth outcome (neonatal death)
Timeframe: Within 28 days after birth
Prevalence of pregnancy outcomes (live birth)
Timeframe: At birth
Prevalence of pregnancy outcomes (stillbirth)
Timeframe: At or after 20 weeks’ gestation but prior to delivery
Prevalence of pregnancy outcomes (spontaneous abortion)
Timeframe: Prior to 20 weeks' gestation
Prevalence of pregnancy complications
Timeframe: From 20 weeks' gestation through the date of delivery
Interventions:
Other: Data collection
Enrollment:
2844
Observational study model:
Cohort
Primary completion date:
2028-31-03
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Herpes Zoster
Product
GSK1437173A
Collaborators
Harvard Pilgrim Health Care Institute
Study date(s)
May 2022 to March 2028
Type
Observational
Phase
4
Participation criteria
Sex
Female
Age
18 - 49 Years
Accepts healthy volunteers
No
- Participant who is pregnant with a pregnancy start date between 01 July 2021 and 30 June 2026. Live births are to be followed for 1 year.
- Participant is a female aged 18-49 years on the pregnancy start date.
- Participant was exposed to a medication(s) that presents a known increased risk for fetal malformations.
- Participant delivered an infant identified as having a chromosomal or genetic anomaly.
Inclusion and exclusion criteria
Inclusion criteria:
- Participant is a female aged 18-49 years on the pregnancy start date.
- Participant meets study definition of systemic lupus erythematosus (SLE), multiple sclerosis (MS), rheumatoid arthritis (RA), inflammatory bowel disease (IBD), psoriasis (PsO)/psoriatic arthritis (PsA), solid organ transplant (SOT), stem cell transplant (SCT), hematologic malignancies (HM), solid tumors (ST), or human immunodeficiency virus (HIV). Codes for immunocompromised conditions will be identified in the health plan claims of the Distributed Research Network (DRN) during the period 273 days prior to the pregnancy start date through the first trimester (98 days after the pregnancy start date). Diagnoses recorded through the first trimester will be included to account for women who may not have frequent visits prior to pregnancy and may have a more complete assessment of medical conditions during the first prenatal care visit.
- Participant has at least 273 days of continuous health plan enrollment with medical and drug benefits prior to the start of pregnancy through the delivery date, with gaps of up to 45 days in coverage being permitted. The 273-day pre-pregnancy period through the first trimester (a period of 98 days after the pregnancy start date) was chosen to allow identification of potential confounders of interest. In Sentinel projects, gaps of 45 days or less in health plan enrolment are typically considered administrative gaps (and not lapses in health plan coverage) and ignored.
Participant who is pregnant with a pregnancy start date between 01 July 2021 and 30 June 2026. Live births are to be followed for 1 year.
Exclusion criteria:
- Participant delivered an infant identified as having a chromosomal or genetic anomaly.
- Ectopic pregnancies, molar pregnancies or induced abortions.
- Multigestation (e.g., twin) pregnancies.
Participant was exposed to a medication(s) that presents a known increased risk for fetal malformations.
Trial location(s)
Location
GSK Investigational Site
Canton, Massachusetts, United States, 02021
Status
Recruitment Complete
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Ongoing
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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