NCT01031069

Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females

Safety and Immunogenicity of Cervarix™ in Human Immunodeficiency Virus Infected Females

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 873 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 15 Years – 25 Years
• Healthy volunteers: Accepted

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).

Conditions

• Infections, Papillomavirus
• Papillomavirus Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	GSK Biologicals' HPV vaccine 580299	Subjects received three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.
BIOLOGICAL	Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil)	Subjects received three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.

Timeline

• Start date: 2010-10-26
• Primary completion: 2016-01-13
• Completion: 2017-04-19
• First posted: 2009-12-14
• Last updated: 2020-07-21
• Results posted: 2019-07-24

Locations

15 sites across 4 countries: Brazil, Estonia, India, Thailand