A Dose-range Study to Assess the Safety & Immunogenicity of a Novel HPV Vaccine When Administered Intramuscularly According to a 3-dose Schedule (0,1,6-mth) in Healthy Adult Females (18-25 Yrs of Age)
Phase 2
18 Years
25 Years
18 Years
25 Years
Not Enrolling
Female
Human Papillomavirus (HPV) Infection, Cervical Neoplasia
Female
Human Papillomavirus (HPV) Infection, Cervical Neoplasia
Trial Information
A Dose-range Study to Assess the Safety & Immunogenicity of a Novel HPV Vaccine When Administered Intramuscularly According to a 3-dose Schedule (0,1,6-mth) in Healthy Adult Females (18-25 Yrs of Age)
Inclusion Criteria:
- A woman between, and including, 18 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 be of non-childbearing potential and have had no more than 6 lifetime
sexual partners.
Exclusion Criteria:
- Pregnant or breastfeeding.
- A woman planning to become pregnant or planning to discontinue contraceptive
precautions during approximately the first nine months of the study (Month 0-8).
- 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, Primary Purpose: Prevention
Outcome Measure:
Evaluation of immune response of the novel HPV vaccine at different dosages at month 7.
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Study ID:
102115
NCT ID:
NCT00231413
Start Date:
March 2005
Completion Date:
March 2006
Related Keywords:
- Human Papillomavirus (HPV) Infection
- Cervical Neoplasia
- Neoplasms
Name | Location |
|---|---|
| GSK Investigational Site | Aurora, Colorado 80012 |
| GSK Investigational Site | Cranston, Rhode Island 02920 |
| GSK Investigational Site | Salt Lake City, Utah 84107 |
