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NCT01610414 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,877
- Enrollment target
NCT01610414: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01610414 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,877 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (143% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01610414, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,877 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of GSK Biologicals' vaccine GSK1437173A in the prevention of Herpes zoster (HZ) in autologous haematopoietic cell transplant recipients 18 years of age and older. To this end, the study will evaluate vaccine efficacy (VE) of the GSK1437173A vaccine, administered on a 2-dose schedule, compared to placebo in reducing the risk of developing HZ in this population.
Primary Outcome
A suspected case of HZ was defined as (1) a new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations), or a vesicular rash suggestive of VZV infection regardless of the distribution, and no alternative diagnosis; or (2) a clinical presentation (symptoms and/or signs) and specific laboratory findings\* suggestive of VZV infection in the absence of characteristic HZ or VZV rash. A suspected case of HZ wa
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Herpes Zoster vaccine GSK1437173A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,877 participants |
| Start Date | 2012-07-13 |
| Est. Completion | 2017-02-01 |
| Phase | Phase 3 |
What the finished NCT01610414 record still lists
NCT01610414 is an interventional study that assigns participants to a tested intervention. Its 1,877 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (143% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01610414 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01610414 about?
NCT01610414 is a clinical study titled "Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A". The purpose of this study is to evaluate the efficacy of GSK Biologicals' vaccine GSK1437173A in the prevention of Herpes zoster (HZ) in autologous haematopoietic cell transplant recipients 18 years of age and older. To this end, the study will evaluate vaccine efficacy (VE) of the GSK1437173A vacci...
What is the current status of trial NCT01610414?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,877 participants. The study started on 2012-07-13. Estimated completion is 2017-02-01.
What interventions are being tested in trial NCT01610414?
The interventions under investigation include: Placebo (BIOLOGICAL), Herpes Zoster vaccine GSK1437173A (BIOLOGICAL).
Who is sponsoring clinical trial NCT01610414?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01610414's enrollment target sits among peer trials
1,877 113th of 2000 higher than 1,888 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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