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NCT01165177 · ClinicalTrials.gov registry record · Phase 3

Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older

A Phase 3 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
16,165
Enrollment target

NCT01165177 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 16,165 participants.

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The verdict

NCT01165177, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
16,165 participants
Enrollment target

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 ≥ 50 years. Two studies \[ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)\] are being 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. The protocol posting of study ZOSTER-022 also deals with the outcome measures related to the pooled analysis.

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL Herpes Zoster Vaccine GSK1437173A

Trial Details

FieldValue
Enrollment Target 16,165 participants
Start Date 2010-08-02
Est. Completion 2015-07-27
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT01165177

The ClinicalTrials.gov registry entry for NCT01165177 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 16,165 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01165177 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01165177 about?

NCT01165177 is a clinical study titled "Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 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 ≥ 50 years. Two studies \[ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)\] are being conducted concurrently to evaluate effi...

What is the current status of trial NCT01165177?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 16,165 participants. The study started on 2010-08-02. Estimated completion is 2015-07-27.

What interventions are being tested in trial NCT01165177?

The interventions under investigation include: Placebo (BIOLOGICAL), Herpes Zoster Vaccine GSK1437173A (BIOLOGICAL).

Who is sponsoring clinical trial NCT01165177?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.