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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

February 10, 2006
July 14, 2014
November 2005
Not Provided
To evaluate antibody responses against HPV-16 and HPV-18 in all HPV vaccine recipients at Month 7.
• To evaluate antibody responses against HPV-16 and HPV-18 in all HPV vaccine recipients at Month 7.
Complete list of historical versions of study NCT00290277 on ClinicalTrials.gov Archive Site
To evaluate safety and reactogenicity throughout the study period.
• To evaluate safety and reactogenicity throughout the study period.
Not Provided
Not Provided
 
Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV Vaccine in Female Subjects Aged 10-14 Years
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

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Infections, Papillomavirus
Biological: HPV-16/18 L1/AS04
Not Applicable.
Other Name: HPV-16/18 L1/AS04
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
Not Provided
Not Provided

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."
Female
10 Years to 14 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00290277
104951
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP