Trial Information
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)
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).
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7.
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
Panama: Ministry of Health
Study ID:
580299/013
NCT ID:
NCT00196924
Start Date:
June 2004
Completion Date:
March 2006
Related Keywords:
- Human Papillomavirus (HPV) Infection
- Cervical Neoplasia
- Neoplasms