CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 873 enrolled
Drug / intervention
GSK Biologicals' HPV vaccine 580299 +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/NCT01031069
NCT01031069Phase 4Completed
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Safety and Immunogenicity of Cervarix™ in Human Immunodeficiency Virus Infected Females

GlaxoSmithKline·interventional·Posted Dec 14, 2009·Updated Jul 21, 2020

In Brief

A Phase 4 clinical trial evaluating GSK Biologicals' HPV vaccine 580299 and Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil) for Infections, Papillomavirus and Papillomavirus Vaccines. Completed, enrolled 873 participants across 15 sites in 4 countries.

Detailed Summary

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IV, observer-blind study is designed to evaluate the safety and immunogenicity of Cervarix in HIV infected females aged 15 to 25 years as compared to Merck's HPV vaccine (Gardasil). For comparative purposes, a group of HIV negative females will also be evaluated. All subjects will receive the HPV vaccine (either Cervarix or Gardasil) according to a three-dose schedule (Day 0, Week 6, Month 6).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Papillomavirus, Papillomavirus Vaccines
CountriesBrazil, Estonia, India, Thailand
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 14, 2009
Enrollment StartOct 26, 2010
Primary CompletionJan 13, 2016
Study CompletionApr 19, 2017
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 16.6 years ago

Interventions

GSK Biologicals' HPV vaccine 580299biological

Subjects received three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.

Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil)biological

Subjects received three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.