CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 225 enrolled
Drug / intervention
HPV-16/18 VLP/AS04 vaccine (Cervarix TM) +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/NCT00485732
NCT00485732Phase 3Completed
CompareCT.gov

A Phase IIIb, Double-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV-16/18 L1 VLP AS04 Vaccine, Administered Intramuscularly in Healthy Female Subjects Aged 15 - 25 Years

GlaxoSmithKline·interventional·Posted Jun 13, 2007·Updated Jul 20, 2018

In Brief

A Phase 3 clinical trial evaluating HPV-16/18 VLP/AS04 vaccine (Cervarix TM) and Placebo for Infections, Papillomavirus. Completed, enrolled 225 participants across 6 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 GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) 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
CountriesSouth Korea
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 13, 2007
Enrollment StartJun 11, 2007
Primary CompletionMar 30, 2008
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 19.1 years ago

Interventions

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

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

Placebobiological

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