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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: Completed Phase 3 study of Herpes Zoster and Herpes Zoster Vaccine, sponsored by GlaxoSmithKline.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Confirmed HZ cases during the study in the modified total vaccinated cohort (mTVc).
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 |
What the finished NCT01165229 record still lists
NCT01165229 is an interventional study that assigns participants to a tested intervention. Its 14,819 participants enrollment target places it among the larger protocols in the corpus, above the 1,247-participant average among 16 other Herpes Zoster trials with a reported enrollment target (1088% higher).
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 names 20 study sites across 8 states, led by 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.
Learn More About Clinical Trials
Similar trials for Herpes Zoster
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01165229's enrollment target sits among peer trials
14,819 1st of 16 higher than 16 of 16 other Herpes Zoster trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Herpes Zoster 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
-
A Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults
ACTIVE NOT RECRUITING · Phase 3
-
Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Prevenar13 in Adults Aged 50 Years and Older
COMPLETED · Phase 3
-
Study to Evaluate Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A When Co-administered With Pneumovax 23™ in Adults Aged 50 Years and Older
COMPLETED · Phase 3
-
Cross-vaccination Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies.
COMPLETED · Phase 3
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Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
RECRUITING · Phase 1
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Safety of Herpes Zoster Subunit (HZ/su) Vaccine During Pregnancy in Adult Women With Immunocompromised Conditions
ACTIVE NOT RECRUITING
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