NCT00169494

Human Papilloma Virus Vaccine Consistency and Non-inferiority Trial in Young Adult Women With GSK Bio HPV-16/18

Immunogenicity: 3 Consecutive Lots of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly at 0,1,6 Month Schedule in Healthy Females Aged 10-25 Years and Demonstrate Non-inferiority of Candidate HPV Vaccine Manufactured by Modified Production Process

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 770 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 10 Years – 25 Years
• Healthy volunteers: Accepted

Summary

Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing processes of GSK Biologicals HPV-16/18 vaccine and the vaccine safety, over 12 months, in young adolescents and women of 10-25 years of age at study start. Approximately 750 study subjects will receive different lots of the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.

Conditions

• Infections, Papillomavirus

Interventions

Type	Name	Description
BIOLOGICAL	HPV-16/18 L1/AS04

Timeline

• Start date: 2004-09-01
• Primary completion: 2005-07-01
• Completion: 2005-07-01
• First posted: 2005-09-15
• Last updated: 2016-09-12

Locations

17 sites across 6 countries: Denmark, Estonia, Finland, Greece, Netherlands, Russia