CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 300 enrolled
Drug / intervention
HPV-16/18 L1 VLP AS04biological
Likely dose
Not stated in 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/NCT00306241
NCT00306241Phase 3Completed
CompareCT.gov

A Phase III, Double-blind, Randomized, Controlled Study to Evaluate Immunogenicity and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine, Administered Intramuscularly (0, 1, 6 Month Schedule) in Healthy Females Aged 18 - 35 Years

GlaxoSmithKline·interventional·Posted Mar 23, 2006·Updated Nov 4, 2016

In Brief

A Phase 3 clinical trial evaluating HPV-16/18 L1 VLP AS04 for Infections, Papillomavirus. Completed, enrolled 300 participants across 1 site.

Detailed Summary

Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will evaluate the immune response induced by the HPV-16/18 L1 VLP AS04 vaccine and the safety of the vaccine. 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--
ConditionsInfections, Papillomavirus
CountriesHong Kong
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 23, 2006
Enrollment StartMar 1, 2006
Primary CompletionJun 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 20.3 years ago

Interventions

HPV-16/18 L1 VLP AS04biological