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
- A female who enrolled in the study 102115 and received three doses of vaccine.
- Written informed consent obtained from the subject prior to enrolment.
- 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:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
HPV-16 and -18 seroconversion rates and GMTs
Outcome Time Frame:
At Months 18, 24, 36 and 48
GSK Clinical Trials
Belgium: Federal Agency for Medicines and Health Products, FAMHP
108052 (FU month 18)
- Prophylaxis for HPV Infections and Cervical Neoplasia
- HPV vaccine
|GSK Investigational Site||Aurora, Colorado 80012|
|GSK Investigational Site||Salt Lake City, Utah 84107|