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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Infections, Papillomavirus

Treatments

Biological: HPV-16/18 L1/AS04

Study type

Interventional

Funder types

Industry

Identifiers

NCT00290277

104951

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 patients

Sex

Female

Ages

10 to 14 years old

Volunteers

Accepts Healthy Volunteers

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."