Trials / Active Not Recruiting
Active Not RecruitingNCT05811754
Safety of Herpes Zoster Subunit (HZ/su) Vaccine During Pregnancy in Adult Women With Immunocompromised Conditions
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
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,844 (estimated)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Female
- Age
- 18 Years – 49 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2022-05-09
- Primary completion
- 2028-03-31
- Completion
- 2028-03-31
- First posted
- 2023-04-13
- Last updated
- 2025-11-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05811754. Inclusion in this directory is not an endorsement.