Trial Information
A Long-term, Follow-up of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Novel HPV Vaccine in Healthy Female Subjects Vaccinated in the Primary Study
Inclusion Criteria:
- A female who enrolled in the study 102115 and received three doses of vaccine.
- Written informed consent obtained from the subject prior to enrolment.
Exclusion Criteria:
- Use (or planned use during the study period) of any investigational or non-registered
product or off-label use of licensed product (drug or vaccine).
- Chronic administration of immunosuppressants or other immune-modifying drugs
occurring less than three months prior to blood sampling.
- Administration of immunoglobulins and/or any blood products within the three months
preceding blood sampling.
- Planned administration of any HPV vaccine, other than that foreseen by the study
protocol, during the study period.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
HPV-16 and -18 seroconversion rates and GMTs
Outcome Time Frame:
At Months 18, 24, 36 and 48
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:
108052 (FU month 18)
NCT ID:
NCT00359619
Start Date:
September 2006
Completion Date:
August 2009
Related Keywords:
- Prophylaxis for HPV Infections and Cervical Neoplasia
- HPV vaccine
- Neoplasms
Name | Location |
GSK Investigational Site |
Aurora, Colorado 80012 |
GSK Investigational Site |
Salt Lake City, Utah 84107 |