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

Infections, Papillomavirus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00290277
• Other study ID #: 104951
• Status: Completed
• Phase: Phase 3
• First received: February 10, 2006
• Last updated: September 27, 2016
• Start date: November 2005
• Est. completion date: August 2006

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 14 Years

Eligibility

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."

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infections, Papillomavirus

Intervention

Biological:
• HPV-16/18 L1/AS04

Locations

Country	Name	City	State
Korea, Republic of	GSK Investigational Site	Daegu
Korea, Republic of	GSK Investigational Site	Kwangju
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate antibody responses against HPV-16 and HPV-18 in all HPV vaccine recipients at Month 7.
Secondary	To evaluate safety and reactogenicity throughout the study period.

External Links

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