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

NCT05811754 | Active Not Recruiting

• 1 other identifier: 214420
• Study Type: observational
• Target: 2,844
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Herpes Zoster

Keywords

Herpes Zoster; Recombinant; Zoster vaccine; Targeted; Safety study; Post-authorization safety study; Pregnant women

Outcome Measures

Primary Outcomes (1)

• Prevalence of Major Congenital Malformations (MCMs)

  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.

  From birth up to 1 year of age

Secondary Outcomes (7)

• Prevalence of additional infant/birth outcomes (small for gestational age, low birthweight, neonatal intensive care unit admission)

  Within 30 days after the infant's date of birth

• Prevalence of additional infant/birth outcome (preterm birth)

  At birth

• Prevalence of additional infant/birth outcome (neonatal death)

  Within 28 days after birth

• Prevalence of pregnancy outcomes (live birth)

  At birth

• Prevalence of pregnancy outcomes (stillbirth)

  At or after 20 weeks' gestation but prior to delivery

Study Arms (2)

HZ/su-Exposed Group

Pregnancies among adult women diagnosed with immunocompromised conditions who were exposed to the HZ/su vaccine during pregnancy.

Other: Data collection

Comparison (Unexposed) Group

Pregnancies among adult women diagnosed with immunocompromised conditions who were not exposed to the HZ/su vaccine during pregnancy.

Other: Data collection

Interventions

Data collection OTHER

This study will be conducted using data provided by U.S. Research Partners in the FDA's Sentinel Surveillance System. Four Research Partners will participate in this study: CVS Health Clinical Trial Services (CTS), Carelon Research, Optum and Harvard Pilgrim Health Care Institute (HPHCI).

Comparison (Unexposed) Group; HZ/su-Exposed Group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Adult pregnant women, 18-49 years of age, diagnosed with an immunocompromised condition who were members of any of the 4 participating Sentinel Research Partners.

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Harvard Pilgrim Health Care Institute: collaborator

Study Sites (1)

GSK Investigational Site

Canton, Massachusetts, 02021, United States

Location

MeSH Terms

Conditions

Herpes Zoster

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 13, 2023
• Study Start: May 9, 2022
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: November 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)