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

Phase 3

Completed

• Conditions: Infections, Papillomavirus

• Registration Number: NCT00290277
• Lead Sponsor: GlaxoSmithKline

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-02-10
• Study First Submitted QC: 2006-02-10
• Study First Posted: 2006-02-13
• Study Completion: 2006-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-27
• Last Update Posted: 2016-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To evaluate antibody responses against HPV-16 and HPV-18 in all HPV vaccine recipients at Month 7.

Secondary Outcome Measures

Name	Time	Method
To evaluate safety and reactogenicity throughout the study period.

Trial Locations

Locations (1)

GSK Investigational Site; 🇰🇷 Seoul, Korea, Republic of