CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,239 enrolled
Drug / intervention
GSK580299, GSK Biological's HPV vaccinebiological
Likely dose
GSK580299 HPV vaccine, 3 intramuscular doses administered at 0, 1, and 6-month scheduleAI-extracted
Key inclusion· 4
  • ✓Previously enrolled in primary study NCT00122681 and received active control hepatitis A vaccine
  • ✓Cannot receive licensed HPV-16/18 L1 VLP AS04 vaccine due to lack of licensure in subject's country or age exceeding licensed age range
  • ✓Female aged 26 years or older at first vaccination
  • ✓Healthy as established by medical history and clinical examination
Key exclusion· 12
  • ✕Pregnant or lactating female
  • ✕Planning to become pregnant during study period and up to 2 months after last dose
  • ✕Previous HPV vaccination or planned non-protocol HPV vaccine
  • ✕Other investigational/non-registered products within 30 days before or during study

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

Search/NCT00849381
NCT00849381Phase 3Completed
CompareCT.gov

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK580299) in Female Brazilian, Taiwanese and Thai Subjects Who Had Received Control Vaccine in Study 580299/008

GlaxoSmithKline·interventional·Posted Feb 23, 2009·Updated Sep 12, 2014

In Brief

A Phase 3 clinical trial evaluating GSK580299, GSK Biological's HPV vaccine for Infections, Papillomavirus. Completed, enrolled 1,239 participants across 9 sites in 3 countries.

Detailed Summary

This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in study 008/580299 and received the control vaccine (Hepatitis A vaccine).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Papillomavirus
CountriesBrazil, Taiwan, Thailand
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 23, 2009
Enrollment StartApr 1, 2009
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 17.4 years ago

Interventions

GSK580299, GSK Biological's HPV vaccinebiological

All subjects will receive 3 doses administered as an intramuscular injection, according to a 0, 1, 6-month schedule.