A Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years

Phase 3

Completed

• Conditions: Infections, Papillomavirus

• Registration Number: NCT00306241
• 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 immune response induced by the HPV-16/18 L1 VLP AS04 vaccine and the safety of the vaccine.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description

The protocol was primarily amended for the following reason:

Merck's tetravalent HPV vaccine, Gardasil®, has been licensed and is now becoming commercially available in an increasing number of countries. Therefore, the study procedures were revised to include questions at every visit to determine if subjects have received an HPV vaccine outside of the study.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-16
• Study First Submitted QC: 2006-03-22
• Study First Posted: 2006-03-23
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-02
• Last Update Posted: 2016-11-04

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
Seroconversion rates to HPV-16 and HPV-18 as assessed by enzyme-linked immunosorbent assay (ELISA)	At Month 7

Secondary Outcome Measures

Name	Time	Method
Occurrence, intensity and relationship to vaccination of solicited general symptoms, and occurrence and intensity of solicited local symptoms	During the 7 days after each and any vaccination
Occurrence, intensity and causal relationship to vaccination of unsolicited symptoms	Within 30 days after any vaccination
Occurrence of SAEs	Throughout the study period (up to Month 7)
Occurrence of new onset chronic diseases and other medically significant conditions regardless of causal relationship to vaccination and intensity.	Throughout the study period (up to Month 7)
Anti-HPV-16/18 antibody titres (by ELISA)	At Month 0 and Month 7

Trial Locations

Locations (1)

GSK Investigational Site; 🇭🇰 Hong Kong, Hong Kong