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Clinical Trials/NCT00290277
NCT00290277
Completed
Phase 3

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

GlaxoSmithKline1 site in 1 country300 target enrollmentNovember 2005
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ConditionsInfections, Papillomavirus

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Infections, Papillomavirus
Sponsor
GlaxoSmithKline
Enrollment
300
Locations
1
Primary Endpoint
To evaluate antibody responses against HPV-16 and HPV-18 in all HPV vaccine recipients at Month 7.
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2005
End Date
August 2006
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • To evaluate safety and reactogenicity throughout the study period.

Study Sites (1)

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