Immunogenicity: 3 Consecutive Lots of GSK Bios' HPV-16/18 Vaccine Admnd Intramuscularly at 0,1,6 Mth Schedule in Healthy Females Aged 10-25 y & Demonstrate Non-inferiority of Candidate HPV Vaccine Manufactured by Modified Production Process
Phase 3
10 Years
25 Years
10 Years
25 Years
Not Enrolling
Female
Human Papillomavirus (HPV) Infection, Cervical Neoplasia
Female
Human Papillomavirus (HPV) Infection, Cervical Neoplasia
Trial Information
Immunogenicity: 3 Consecutive Lots of GSK Bios' HPV-16/18 Vaccine Admnd Intramuscularly at 0,1,6 Mth Schedule in Healthy Females Aged 10-25 y & Demonstrate Non-inferiority of Candidate HPV Vaccine Manufactured by Modified Production Process
Inclusion Criteria:
- A woman between, and including, 10 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 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 lot-to-lot consistency in terms of immunogenicity of 3 lots of HPV-16/18 vaccine.
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
Denmark: The Danish National Committee on Biomedical Research Ethics
Study ID:
580299/012
NCT ID:
NCT00169494
Start Date:
September 2004
Completion Date:
July 2005
Related Keywords:
- Human Papillomavirus (HPV) Infection
- Cervical Neoplasia
- Neoplasms
Name | Location |
|---|
