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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-08-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Infections, Papillomavirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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HPV-16/18 L1/AS04

Intervention Type BIOLOGICAL

Eligibility Criteria

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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."

Minimum Eligible Age

10 Years

Maximum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Daegu, , South Korea

Site Status

GSK Investigational Site

Kwangju, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

Countries

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South Korea

Study Documents

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