CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,113 enrolled
Drug / intervention
Cervarix +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/NCT00689741
NCT00689741Phase 2Completed
CompareCT.gov

A Double-blind, Placebo-controlled, Randomised Study of the Efficacy of an HPV-16/18 VLP Vaccine in the Prevention of HPV-16 and/or HPV-18 Cervical Infection in Healthy Adolescent and Young Adult Women in North America and Brazil.

GlaxoSmithKline·interventional·Posted Jun 4, 2008·Updated Sep 12, 2016

In Brief

A Phase 2 clinical trial evaluating Cervarix and placebo for Infections, Papillomavirus. Completed, enrolled 1,113 participants.

Detailed Summary

The purpose of this phase IIB MedImmune-sponsored study was to evaluate the efficacy of the HPV-16/18 VLP vaccine in the prevention of infection with HPV-16 and/or HPV-18 in adolescent and young adult women. A vaccine that prevents, or even reduces, the incidence of the common types of high-risk HPVs, particularly HPV-16 and HPV-18, could result in significant reduction in the incidence of cervical cancer and cancer-related mortality, as well as a reduction in the incidence of surgical procedures following abnormal Pap smears.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Papillomavirus
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 4, 2008
Enrollment StartJan 1, 2001
Primary CompletionApr 1, 2003
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.1 years ago

Interventions

Cervarixbiological

3 doses of IM injection

placebobiological

3 doses of IM injection of Al(OH)3 placebo