- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00290277
Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV Vaccine in Female Subjects Aged 10-14 Years
September 27, 2016 updated by: GlaxoSmithKline
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Daegu, Korea, Republic of, 700-712
- GSK Investigational Site
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Kwangju, Korea, Republic of
- GSK Investigational Site
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Seoul, Korea, Republic of, 138-736
- GSK Investigational Site
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Seoul, Korea, Republic of, 137-701
- GSK Investigational Site
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Seoul, Korea, Republic of, 110-744
- GSK Investigational Site
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Seoul, Korea, Republic of, 135-720
- GSK Investigational Site
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Seoul, Korea, Republic of, 135-710
- GSK Investigational Site
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Seoul, Korea, Republic of, 133--792
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 14 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To evaluate antibody responses against HPV-16 and HPV-18 in all HPV vaccine recipients at Month 7.
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Secondary Outcome Measures
Outcome Measure |
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To evaluate safety and reactogenicity throughout the study period.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Study Completion (Actual)
August 1, 2006
Study Registration Dates
First Submitted
February 10, 2006
First Submitted That Met QC Criteria
February 10, 2006
First Posted (Estimate)
February 13, 2006
Study Record Updates
Last Update Posted (Estimate)
September 28, 2016
Last Update Submitted That Met QC Criteria
September 27, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 104951
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
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Clinical Study Report
Information identifier: 104951Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 104951Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 104951Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 104951Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: 104951Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 104951Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 104951Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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