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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: February 10, 2006
Last updated: September 29, 2011
Last verified: September 2011

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 to cervical cancer in women . This study will evaluate the immunogenicity and the safety of the HPV vaccine in female subjects aged 10 - 14 years in Korea.

Condition Intervention Phase
Human Papillomavirus (HPV) Infection
Cervical Neoplasia
Biological: HPV-16/18 L1/AS04
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Administered Intramuscularly According to a 0,1,6 Mth Schedule in Healthy Female Subjects Aged 10-14 Yrs

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To evaluate antibody responses against HPV-16 and HPV-18 in all HPV vaccine recipients at Month 7.

Secondary Outcome Measures:
  • To evaluate safety and reactogenicity throughout the study period.

Estimated Enrollment: 300
Study Start Date: November 2005
Intervention Details:
    Biological: HPV-16/18 L1/AS04
    Other Name: HPV-16/18 L1/AS04
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.


Ages Eligible for Study:   10 Years to 14 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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."
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290277

Korea, Republic of
GSK Investigational Site
Daegu, Korea, Republic of, 700-712
GSK Investigational Site
Kwangju, Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 138-736
GSK Investigational Site
Seoul, Korea, Republic of, 133--792
GSK Investigational Site
Seoul, Korea, Republic of, 110-744
GSK Investigational Site
Seoul, Korea, Republic of, 135-720
GSK Investigational Site
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00290277     History of Changes
Other Study ID Numbers: 104951
Study First Received: February 10, 2006
Last Updated: September 29, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:

ClinicalTrials.gov processed this record on April 17, 2014