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COMPLETED 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

NCT01165229 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 14,819 participants
Start Date 2010-08-02
Est. Completion 2015-07-24
Phase Phase 3

Sponsor

GlaxoSmithKline

558 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 14,819 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01165229 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Arizona, Florida, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01165229?

The interventions under investigation include: Placebo (BIOLOGICAL), Herpes Zoster Vaccine GSK1437173A (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01165229?

This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial