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NCT00224484 · ClinicalTrials.gov registry record · Phase 3

Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old

A Phase 3 study of Herpes Simplex, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
5,960
Enrollment target
20
Study locations

NCT00224484 is a Phase 3 study of Herpes Simplex that has completed, run by GlaxoSmithKline. The registered enrollment target is 5,960 participants, above the 234-participant average among 4 other Herpes Simplex trials with a reported enrollment target (2447% higher). The trial reports 20 study locations across 6 states.

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The verdict

NCT00224484, a Phase 3 study of Herpes Simplex, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
5,960 participants
Enrollment target
20
Study locations

Study Summary

Main goal of this study is to compare the occurrence of serious adverse events (SAEs) between the herpes simplex (gD2-AS04) vaccine group and the Saline control group throughout the study period (up to month 12). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions Studied

Herpes Simplex

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL GSK208141
  • BIOLOGICAL Havrix (investigational formulation)

Study Locations (20)

Arizona

  • GSK Investigational Site - Chandler
  • GSK Investigational Site - Mesa
  • GSK Investigational Site - Mesa
  • GSK Investigational Site - Tempe
  • GSK Investigational Site - Tucson

Colorado

  • GSK Investigational Site - Centennial
  • GSK Investigational Site - Littleton
  • GSK Investigational Site - Thornton
  • GSK Investigational Site - Westminster
  • GSK Investigational Site - Wheat Ridge

California

  • GSK Investigational Site - Beverly Hills
  • GSK Investigational Site - Fountain Valley
  • GSK Investigational Site - Long Beach
  • GSK Investigational Site - Rolling Hills Estates

Florida

  • GSK Investigational Site - Clearwater
  • GSK Investigational Site - Cocoa Beach
  • GSK Investigational Site - Melbourne

Alabama

  • GSK Investigational Site - Birmingham
  • GSK Investigational Site - Birmingham

Connecticut

  • GSK Investigational Site - Norwich

Trial Details

FieldValue
Enrollment Target 5,960 participants
Start Date 2004-04-07
Est. Completion 2007-07-24
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00224484

The ClinicalTrials.gov registry entry for NCT00224484 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 5,960 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 234-participant average among 4 other Herpes Simplex trials with a reported enrollment target (2447% higher). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Herpes Simplex appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00224484 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Arizona, Colorado, California.

Frequently Asked Questions

What is clinical trial NCT00224484 about?

NCT00224484 is a clinical study titled "Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old". Main goal of this study is to compare the occurrence of serious adverse events (SAEs) between the herpes simplex (gD2-AS04) vaccine group and the Saline control group throughout the study period (up to month 12). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, S...

What is the current status of trial NCT00224484?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 5,960 participants. The study started on 2004-04-07. Estimated completion is 2007-07-24.

What conditions does trial NCT00224484 study?

This clinical trial studies the following conditions: Herpes Simplex.

What interventions are being tested in trial NCT00224484?

The interventions under investigation include: Placebo (BIOLOGICAL), GSK208141 (BIOLOGICAL), Havrix (investigational formulation) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00224484?

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

Where is trial NCT00224484 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.