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NCT01165229 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older
A Phase 3 study of Herpes Zoster and Herpes Zoster Vaccine, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 14,819
- Enrollment target
- 20
- Study locations
NCT01165229 is a Phase 3 study of Herpes Zoster and Herpes Zoster Vaccine that has completed, run by GlaxoSmithKline. The registered enrollment target is 14,819 participants, above the 1,247-participant average among 16 other Herpes Zoster trials with a reported enrollment target (1088% higher). The trial reports 20 study locations across 8 states.
The verdict
NCT01165229, a Phase 3 study of Herpes Zoster and Herpes Zoster Vaccine, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 14,819 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 70 years. Two studies (Zoster-006 \[NCT01165177\] and Zoster-022 \[NCT01165229\]) will be conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. This protocol posting also deals with the outcome measures related to the pooled analysis.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Herpes Zoster Vaccine GSK1437173A
Study Locations (20)
Arizona
- GSK Investigational Site - Mesa
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Tucson
Florida
- GSK Investigational Site - Clearwater
- GSK Investigational Site - DeLand
- GSK Investigational Site - Jacksonville
- GSK Investigational Site - Jacksonville
- GSK Investigational Site - West Palm Beach
California
- GSK Investigational Site - Spring Valley
- GSK Investigational Site - Vista
Kansas
- GSK Investigational Site - Overland Park
- GSK Investigational Site - Wichita
Maryland
- GSK Investigational Site - Baltimore
- GSK Investigational Site - Columbia
Nevada
- GSK Investigational Site - Las Vegas
- GSK Investigational Site - Las Vegas
Idaho
- GSK Investigational Site - Meridian
Missouri
- GSK Investigational Site - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14,819 participants |
| Start Date | 2010-08-02 |
| Est. Completion | 2015-07-24 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01165229
The ClinicalTrials.gov registry entry for NCT01165229 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 14,819 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,247-participant average among 16 other Herpes Zoster trials with a reported enrollment target (1088% higher). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Herpes Zoster appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01165229 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Arizona, Florida, California.
Frequently Asked Questions
What is clinical trial NCT01165229 about?
NCT01165229 is a clinical study titled "Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older". The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 70 years. Two studies (Zoster-006 \[NCT01165177\] and Zoster-022 \[NCT01165229\]) will be conducted concurrently to evaluate effi...
What is the current status of trial NCT01165229?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 14,819 participants. The study started on 2010-08-02. Estimated completion is 2015-07-24.
What conditions does trial NCT01165229 study?
This clinical trial studies the following conditions: Herpes Zoster, Herpes Zoster Vaccine.
What interventions are being tested in trial NCT01165229?
The interventions under investigation include: Placebo (BIOLOGICAL), Herpes Zoster Vaccine GSK1437173A (BIOLOGICAL).
Who is sponsoring clinical trial NCT01165229?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01165229 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Idaho, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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