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

NCT05811754 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2844

Last updated 2025-11-12

No results posted yet for this study

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

Interventions

OTHER

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).

Sponsors & Collaborators

  • Harvard Pilgrim Health Care Institute

    collaborator UNKNOWN

  • GlaxoSmithKline

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-09
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05811754 on ClinicalTrials.gov