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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: Completed Phase 3 study, sponsored by GlaxoSmithKline.

NCT01165177 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 16,165 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1997% higher). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Confirmed HZ cases during the study were assessed in the Modified Total Vaccinated Cohort (mTVc)

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
GlaxoSmithKline

1,345 total trials

What the finished NCT01165177 record still lists

NCT01165177 is an interventional study that assigns participants to a tested intervention. Its 16,165 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1997% higher).

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

NCT01165177 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01165177's enrollment target sits among peer trials

16,165 12th of 2000 higher than 1,989 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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Source: ClinicalTrials.gov NCT01165177, the US trial registry maintained by the National Library of Medicine. NCT01165177 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.