Safety of Herpes Zoster Subunit (HZ/su) Vaccine During Pregnancy in Adult Women With Immunocompromised Conditions

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05811754

Collaborator

Harvard Pilgrim Health Care Institute (Other)

2,844

Enrollment

72.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this postmarketing 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).

Condition or Disease	Intervention/Treatment	Phase
Herpes Zoster	Other: Data collection

Study Design

Study Type:

Observational

Anticipated Enrollment :

2844 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Anticipated Study Start Date :

Apr 3, 2023

Anticipated Primary Completion Date :

May 31, 2028

Anticipated Study Completion Date :

Apr 30, 2029

Arms and Interventions

Arm	Intervention/Treatment
HZ/su-Exposed Group Pregnant adult women diagnosed with immunocompromised (IC) conditions exposed to HZ/su vaccine during pregnancy.	Other: Data collection This study will be conducted using data provided by U.S. Data Partners in the FDA's Sentinel System. Three Data Partners will participate in this study: CVS Health Clinical Trial Services (CTS), HealthCore, Inc., and Optum.
Comparison (Unexposed) Group Pregnant adult women diagnosed with immunocompromised (IC) conditions who were not vaccinated with HZ/su vaccine (i.e., not receiving at least one dose of HZ/su vaccine during pregnancy).	Other: Data collection This study will be conducted using data provided by U.S. Data Partners in the FDA's Sentinel System. Three Data Partners will participate in this study: CVS Health Clinical Trial Services (CTS), HealthCore, Inc., and Optum.

Arm

Intervention/Treatment

HZ/su-Exposed Group

Pregnant adult women diagnosed with immunocompromised (IC) conditions exposed to HZ/su vaccine during pregnancy.

Other: Data collection

This study will be conducted using data provided by U.S. Data Partners in the FDA's Sentinel System. Three Data Partners will participate in this study: CVS Health Clinical Trial Services (CTS), HealthCore, Inc., and Optum.

Comparison (Unexposed) Group

Pregnant adult women diagnosed with immunocompromised (IC) conditions who were not vaccinated with HZ/su vaccine (i.e., not receiving at least one dose of HZ/su vaccine during pregnancy).

Other: Data collection

Outcome Measures

Primary Outcome Measures

Prevalence of Major Congenital Malformations (MCMs) [From birth up to 1 year of age]
The prevalence of MCMs among live births from women with immunocompromised conditions exposed to HZ/su vaccine compared to those not exposed to HZ/su vaccine during pregnancy is evaluated. An MCM (birth defect or structural defect) is defined as a defect, which has either cosmetic or functional significance to the child.

Secondary Outcome Measures

Prevalence of additional infant/birth outcomes [Within 30 days after the infant's date of birth]
The prevalence of additional infant/birth outcomes (preterm birth, small for gestational age [SGA], low birthweight [LBW], neonatal intensive care unit [NICU] admission, neonatal death) among live births in women with immunocompromised conditions exposed to HZ/su vaccine versus those not exposed to HZ/su vaccine during pregnancy is assessed.
Prevalence of pregnancy outcomes [At or after 20 weeks gestation but prior to delivery (stillbirth) and prior to 20 weeks gestation (spontaneous abortion)]
The prevalence of pregnancy outcomes that include non-live birth (stillbirth and spontaneous abortion) among non-livebirth pregnancies in women with immunocompromised conditions exposed to HZ/su vaccine versus those not exposed to HZ/su vaccine during pregnancy is assessed.
Prevalence of pregnancy complications [From 20 weeks gestation through the date of delivery]
The prevalence of pregnancy complications (placental abruption, preeclampsia and eclampsia) among livebirth and non-livebirth pregnancies in women with immunocompromised conditions exposed to HZ/su vaccine versus those not exposed to HZ/su vaccine during pregnancy is assessed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Participant who is pregnant with a pregnancy start date between July 1, 2021 and June 30, 2026. Live births are to be followed for 1 year.
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 (IC) 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.

Exclusion Criteria:

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.
Ectopic pregnancies, molar pregnancies or induced abortions.
Multigestation (e.g., twin) pregnancies.