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

March 31, 2023 updated by: GlaxoSmithKline

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2844

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult pregnant women, 18-49 years of age, diagnosed with an immunocompromised condition.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Major Congenital Malformations (MCMs)
Time Frame: 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.
From birth up to 1 year of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of additional infant/birth outcomes
Time Frame: 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.
Within 30 days after the infant's date of birth
Prevalence of pregnancy outcomes
Time Frame: 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.
At or after 20 weeks gestation but prior to delivery (stillbirth) and prior to 20 weeks gestation (spontaneous abortion)
Prevalence of pregnancy complications
Time Frame: 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.
From 20 weeks gestation through the date of delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Collaborators

Harvard Pilgrim Health Care Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 3, 2023

Primary Completion (Anticipated)

May 31, 2028

Study Completion (Anticipated)

April 30, 2029

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

March 31, 2023

First Posted (Actual)

April 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 214420

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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