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 efficacy of GlaxoSmithKline (GSK) Biologicals HPV 16/18 VLP/AS04 vaccine to prevent infection associated cervical pre-cancer and with HPV -16 or -18 and evaluate the vaccine safety, over 48 months, in young adolescents and women of 15-25 years of age at study start. Approximately 18,000 study subjects will either receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule.

Condition	Intervention	Phase
Cervix Neoplasms Papillomavirus infections	Vaccine: HPV 16/18 VLP AS04	Phase III

Further Study Details: 

Primary Outcomes: Efficacy in prevention of persistent infection and histopathologically confirmed cervical intraepithelial neoplasia (CIN)2+ associated with HPV-16 or HPV-18 cervical infection
Secondary Outcomes: Safety of HPV vaccine in entire study period; Efficacy in prevention of persistent infection and histopathologically confirmed CIN1+ or CIN2+ associated with other oncogenic HPV types; Vaccine immunogenicity
Expected Total Enrollment:  18000

NOTE: Some 178 centers participate in this study. Given that the recruitment is completed, the researchers have listed one center per country in this website. If required, further details of centers available on request.

Ages Eligible for Study:  15 Years   -   25 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• A woman between, and including, 15 and 25 years of age at the time of the first vaccination
• Written informed consent from the subject prior to enrolment.
• Subject must be free of obvious health problems
• Subject must have intact cervix (e.g. no history of cauterisation or surgical treatment involving damage to the transformation zone of cervix).

Exclusion Criteria:

• Pregnant or breastfeeding. Women must be at least 3 months post –pregnancy and or not breastfeeding to enter the study.
• A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Month 0-8).
• Previous vaccination against human papillomavirus (HPV)
• Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality.
• History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease.

Florida
      West Palm Beach,  Florida,  United States
Australia, Victoria
      Melbourne,  Victoria,  Australia
Belgium
      Leuven,  Belgium
Brazil
      Campinas,  Brazil
Canada, Manitoba
      Winnipeg,  Manitoba,  Canada
Finland
      Helsinki,  Finland
Germany
      Bayern,  Germany
Italy
      Lombardia,  Italy
Mexico
      Mexico City,  Mexico
Philippines
      Makati City,  Philippines
Spain
      Barcelona,  Spain
Taiwan
      Taipei,  Taiwan
Thailand
      Bangkok,  Thailand
United Kingdom
      Manchester,  United Kingdom

Study chairs or principal investigators

Clinical Trials,  Study Director,  GlaxoSmithKline   

Study ID Numbers:  580299/008
Last Updated:  August 1, 2005
Record first received:  July 20, 2005
ClinicalTrials.gov Identifier:  NCT00122681
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23