NCT00337818

Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women

A Long-term, Open, Follow-up of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV-16/18 L1/AS04 Vaccine in Healthy Female Subjects Vaccinated Either Pre- or Post-menarche in the Primary Study

• 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

The study will be extended for subjects who received all three doses of vaccine in Finland, Denmark and Estonia to determine long-term safety and immunogenicity of the HPV-16/18 vaccine. 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 GlaxoSmithKline 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.

Detailed description

Approximately 750 study subjects received different lots of the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

• Papillomavirus Type 16/18 Infection
• Cervical Intraepithelial Neoplasia

Interventions

Type	Name	Description
BIOLOGICAL	Cervarix™	Three doses of vaccine according to a 0, 1, 6 month schedule (during the primary study)

Timeline

• Start date: 2006-06-01
• Primary completion: 2006-06-01
• Completion: 2009-01-01
• First posted: 2006-06-16
• Last updated: 2017-05-30
• Results posted: 2010-03-02

Locations

1 site across 1 country: Estonia