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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00290277
First received: February 10, 2006
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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
Infections, Papillomavirus
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

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.

Enrollment: 300
Study Start Date: November 2005
Intervention Details:
    Biological: HPV-16/18 L1/AS04
    Not Applicable.
    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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290277

Locations
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, 135-710
GSK Investigational Site
Seoul, Korea, Republic of, 137-701
GSK Investigational Site
Seoul, Korea, Republic of, 135-720
GSK Investigational Site
Seoul, Korea, Republic of, 110-744
GSK Investigational Site
Seoul, Korea, Republic of, 133--792
GSK Investigational Site
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00290277     History of Changes
Other Study ID Numbers: 104951
Study First Received: February 10, 2006
Last Updated: July 14, 2014
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on September 14, 2014