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Safety of Herpes Zoster Subunit (HZ/su) Vaccine During Pregnancy in Adult Women With Immunocompromised Conditions
NCT05811754 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- OTHER Data collection
Study Locations (1)
Massachusetts
- GSK Investigational Site — Canton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,844 participants |
| Start Date | 2022-05-09 |
| Est. Completion | 2028-03-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05811754
The ClinicalTrials.gov registry entry for NCT05811754 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,844 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Herpes Zoster appearing as the primary indexed condition, and to 1 intervention — of which Data collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05811754 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05811754 about?
NCT05811754 is a clinical study titled "Safety of Herpes Zoster Subunit (HZ/su) Vaccine During Pregnancy in Adult Women With Immunocompromised Conditions". 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 malfo...
What is the current status of trial NCT05811754?
This trial is currently active not recruiting. The enrollment target is 2,844 participants. The study started on 2022-05-09. Estimated completion is 2028-03-31.
What conditions does trial NCT05811754 study?
This clinical trial studies the following conditions: Herpes Zoster. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05811754?
The interventions under investigation include: Data collection (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05811754?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05811754 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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