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

NCT00224484 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5960

Last updated 2019-01-07

Study results available
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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

  • Herpes Simplex

Interventions

BIOLOGICAL

GSK208141

3 intramuscular doses

BIOLOGICAL

Havrix (investigational formulation)

3 intramuscular doses

BIOLOGICAL

Placebo

3 intramuscular doses

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-04-07
Primary Completion
2007-07-24
Completion
2007-07-24

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Denmark
  • Estonia
  • France
  • Greece
  • Hungary
  • Iceland
  • Lithuania
  • Netherlands
  • New Zealand
  • Norway
  • Romania
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00224484 on ClinicalTrials.gov