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

NCT ID: NCT05811754

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 2844 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-09
• Study Completion Date: 2028-03-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

HZ/su-Exposed Group

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

Data collection

Intervention Type: 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

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

Data collection

Intervention Type: 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).

Interventions

Data collection

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Harvard Pilgrim Health Care Institute

UNKNOWN

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GSK Investigational Site

Canton, Massachusetts, United States

Countries

United States

Other Identifiers

214420

Identifier Type: -

Identifier Source: org_study_id