CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 150 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/NCT00586339
NCT00586339Phase 2Completed
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Evaluation of the Safety and Immunogenicity of GlaxoSmithKline Biologicals' HPV Vaccine 580299 (Cervarix) in Adult Human Immunodeficiency Virus (HIV) Infected Female Subjects

GlaxoSmithKline·interventional·Posted Jan 4, 2008·Updated Jan 3, 2020

In Brief

A Phase 2 clinical trial evaluating Cervarix and Placebo Control for Infections, Papillomavirus. Completed, enrolled 150 participants across 1 site.

Detailed Summary

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. The current study is designed to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' HPV vaccine 580299 in HIV infected adult females living in the Republic of South Africa. The study is double blinded, randomized for HIV positive subjects and open for HIV negative subjects. 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 Africa
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 4, 2008
Enrollment StartJan 17, 2008
Primary CompletionJul 18, 2011
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 18.5 years ago

Interventions

Cervarixbiological

Intramuscular injection, 3 doses

Placebo Controlbiological

Intramuscular injection, 3 doses