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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


Phase 2
18 Years
25 Years
Not Enrolling
Female
Prophylaxis for HPV Infections and Cervical Neoplasia

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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 SiteAurora, Colorado  80012
GSK Investigational SiteSalt Lake City, Utah  84107