CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 271 enrolled
Drug / intervention
Placebo +1 morebiological
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/NCT00345878
NCT00345878Phase 3Completed
CompareCT.gov

Phase 3, Open, Age-stratified Study to Assess Immunogenicity and Safety of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to 3-dose Schedule (0,1,6 Months) in Healthy Female Subjects Aged 15 - 55 Years and Long Term Follow-up

GlaxoSmithKline·interventional·Posted Jun 29, 2006·Updated Jul 20, 2018

In Brief

A Phase 3 clinical trial evaluating Placebo and HPV-16/18 L1 VLP AS04 (Cervarix TM) for Infections, Papillomavirus. Completed, enrolled 271 participants across 2 sites.

Detailed Summary

Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. The infection of the cervix by certain oncogenic types of HPV, if not cleared, can lead to cervical cancer in women. This study will evaluate the immunogenicity and safety of the HPV-16/18 L1 VLP AS04 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
CountriesMalaysia
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 29, 2006
Enrollment StartSep 25, 2006
Primary CompletionDec 21, 2007
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 20.0 years ago

Interventions

Placebobiological

Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.

HPV-16/18 L1 VLP AS04 (Cervarix TM)biological

Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.