Evaluate the Safety & Immunogenicity of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to a 0,1,6 Mth Schedule in Healthy Female Subjects (10 - 14 Years)
A woman between, and including, 10 and 14 years of age at the time of the first
Written informed consent from the subject prior to enrolment. Subject must be free of
obvious health problems. Subject must have negative urine pregnancy test.
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).
Type of Study:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7.
GSK Clinical Trials
Panama: Ministry of Health
- Human Papillomavirus (HPV) Infection
- Cervical Neoplasia