CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 346 enrolled
Drug / intervention
GSK Biological's HPV vaccine GSK580299 (Cervarix™)biological
Likely dose
GSK Biological's HPV vaccine GSK580299 (Cervarix™) 0.5 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00799825
NCT00799825Phase 3Completed
CompareCT.gov

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK580299) in Female American and Canadian Subjects Who Had Received Control Vaccine in Study 580299/008

GlaxoSmithKline·interventional·Posted Dec 1, 2008·Updated Jul 12, 2018

In Brief

A Phase 3 clinical trial evaluating GSK Biological's HPV vaccine GSK580299 (Cervarix™) for Infections, Papillomavirus. Completed, enrolled 346 participants across 48 sites in 2 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 580299/008 and received the control vaccine (Hepatitis A vaccine).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Papillomavirus
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 1, 2008
Enrollment StartJan 1, 2009
Primary CompletionAug 2, 2012
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 17.6 years ago

Interventions

GSK Biological's HPV vaccine GSK580299 (Cervarix™)biological

All subjects will receive a 0.5 ml dose administered as an intramuscular injection, according to a 0, 1, 6-month schedule.