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HerpeVac Trial for Young Women

NCT00057330 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8323

Last updated 2018-08-27

Study results available
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Summary

The primary purpose of this study is to see if a herpes vaccine may prevent genital herpes disease in women who are not infected. The study will enroll approximately 7550 healthy women. These women will be randomly assigned to 1 of 2 possible study groups: herpes vaccine (experimental group) or hepatitis A vaccine (control group). Participants will receive their assigned vaccine at 0, 1, and 6 months. Participants will have 9 scheduled study visits and additional unscheduled visits for an evaluation of herpes if it is suspected. Participants will be involved in study related procedures for up to 20 months.

Conditions

  • Herpes Simplex Infection

Interventions

BIOLOGICAL

HSV vaccine or SB208141, GSK Biologicals' glycoprotein D (gD)-Alum/3-deacylated form of Monophosphoryl Lipid A (MPL) candidate genital herpes vaccine

the vaccine was administered intramuscularly in the non-dominant deltoid

BIOLOGICAL

Havrix™, GlaxoSmithKline (GSK) Biologicals' licensed Hepatitis A vaccine

the vaccine was administered intramuscularly in the non-dominant deltoid

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-01-14
Primary Completion
2009-08-22
Completion
2009-08-22

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

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 NCT00057330 on ClinicalTrials.gov