Evaluate the Safety and Immunogenicity of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to a 0,1,6 Month Schedule in Healthy Female Subjects (10 - 14 Years)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Infections, Papillomavirus
- Sponsor
- GlaxoSmithKline
- Enrollment
- 2067
- Locations
- 1
- Primary Endpoint
- Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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 safety and immunogenicity of GSK Biologicals HPV-16/18 vaccine over 12 months, in pre-teen and adolescent women of 10-14 years of age at study start. Approximately 2000 study subjects will receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A woman between, and including, 10 and 14 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 negative urine pregnancy test.
Exclusion Criteria
- •Pregnant or breastfeeding. 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.
- •Previous vaccination against human papillomavirus (HPV).
Outcomes
Primary Outcomes
Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7.
Secondary Outcomes
- Safety of HPV vaccine in entire study period. Vaccine immunogenicity.