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Status:

COMPLETED

Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV Vaccine in Female Subjects Aged 10-14 Years

Lead Sponsor:

GlaxoSmithKline

Conditions:

Infections, Papillomavirus

Eligibility:

FEMALE

10-14 years

Phase:

PHASE3

Brief Summary

Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time t...

Detailed Description

Study participants will receive either HPV or hepatitis A vaccine, study duration will last for 7 months and involve a total of 4 visits.

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • A female subject between, and including, 10 and 14 years of age at the time of the first vaccination.
  • Written informed assent from the subject and informed consent from the parent or guardian of the subject should be obtained prior to enrolment.
  • Subjects must have a negative urine pregnancy test.
  • Healthy subject before entering the study as established by medical history and clinical examination.
  • Subject must be of non-childbearing potential.
  • Exclusion criteria:
  • Pregnant or breastfeeding.
  • Previous vaccination against HPV.
  • Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality
  • History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes, or autoimmune disease."

Exclusion

    Key Trial Info

    Start Date :

    November 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 1 2006

    Estimated Enrollment :

    300 Patients enrolled

    Trial Details

    Trial ID

    NCT00290277

    Start Date

    November 1 2005

    End Date

    August 1 2006

    Last Update

    September 28 2016

    Active Locations (8)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (8 locations)

    1

    GSK Investigational Site

    Daegu, South Korea, 700-712

    2

    GSK Investigational Site

    Kwangju, South Korea

    3

    GSK Investigational Site

    Seoul, South Korea, 110-744

    4

    GSK Investigational Site

    Seoul, South Korea, 133--792