CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 5,960 enrolled
Drug / intervention
GSK208141 +2 morebiological
Likely dose
GSK208141 3 intramuscular doses (specific dose per injection not stated)AI-extracted
Key inclusion· 3
  • ✓Healthy female aged 10-17 years at first vaccination
  • ✓Negative urine pregnancy test required
  • ✓If of childbearing potential, must use effective contraception for 30 days before vaccination and 2 months after completion of vaccination series
Key exclusion· 15
  • ✕Any investigational or non-registered product within 30 days before first vaccine dose
  • ✕Pregnant or lactating female
  • ✕Planning to become pregnant or likely to become pregnant during first 8 months of study
  • ✕Current clinical signs or symptoms of orolabial herpes, herpetic whitlow, or genital herpes

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00224484
NCT00224484Phase 3Completed
CompareCT.gov

A Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Herpes Simplex Candidate Vaccine (gD2-AS04) in Healthy HSV Seronegative and Seropositive Female Subjects Aged 10-17 Years.

GlaxoSmithKline·interventional·Posted Sep 23, 2005·Updated Jan 7, 2019

In Brief

A Phase 3 clinical trial evaluating GSK208141, Havrix (investigational formulation), and 1 other intervention for Herpes Simplex. Completed, enrolled 5,960 participants across 151 sites in 18 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHerpes Simplex
CountriesAustralia, Belgium, Canada, Denmark, Estonia, France, Greece, Hungary, Iceland, Lithuania, Netherlands, New Zealand, Norway, Romania, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 23, 2005
Enrollment StartApr 7, 2004
Primary CompletionJul 24, 2007
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 20.8 years ago

Interventions

GSK208141biological

3 intramuscular doses

Havrix (investigational formulation)biological

3 intramuscular doses

Placebobiological

3 intramuscular doses