GSK: Protocol Summary for 580299/011

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Protocol Summary for 580299/011

Protocol Summary
Protocol Id:	580299/011
Secondary Ids:
Title:	An observer-blind, randomized, controlled study to assess the immunogenicity and safety of GlaxoSmithKline Biologicals' HPV vaccine administered intramuscularly according to a 0, 1, 6 month schedule in healthy male subjects aged 10-18 years
Phase:	phase 2
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?:	no
Study Type:	Interventional
Oversight Authority:	Finland: Ethics Committee
Collaborators:
Brief Summary:
Detailed Description:
Record Verification Date:	November 2012
Status:	Completed
Why Study Stopped:
Study Start Date:	April 2006
Study Completion Date:
Study Completion Date Type:
Primary Completion Date:
Primary Completion Date Type:
Primary Purpose:	prevention
Allocation:	Randomized
Masking:	Single Blind
Masked Subject:	no
Masked Caregiver:	no
Masked Investigator:	no
Masked Assessor:	no
Study Design (Assignment):	Parallel Assignment
Study Classification (Endpoint):
Primary Outcomes:	Demonstration of immunogenicity of HPV vaccine in males.
Secondary Outcomes:	Evaluation of safety and reactogenicity throughout the entire study.
Conditions:	Prophylaxis HPV Infection
Keywords:
Eligibility Criteria:	Click to view inclusion/exclusion criteria Inclusion criteria: • A male between, and including, 10 and 18 years of age at the time of the first vaccination. • Written informed consent obtained from the subject prior to enrolment • For subjects below the legal age of consent, a written informed consent must be obtained from the subject’s parent/guardian. In addition, a written informed assent must be obtained from the subject. • Healthy subjects as established by medical history and clinical examination before entering into the study. • Free of obvious health problems as established by medical history and clinical examination before entering into the study. Exclusion criteria: • Previous vaccination against Human Papillomavirus (HPV). • Previous vaccination against Hepatitis B, known clinical history of Hepatitis B infection. • Cancer or autoimmune disease under treatment.
Gender:	Male
Minimum Age:	10 Year
Maximum Age:	18 Year
Enrollment:	270
Enrollment Type:
Healthy Volunteers?:	yes
Central Contact:	Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official:	GSK Clinical Trials
Overall Study Official Affiliation:	GlaxoSmithKline
Overall Study Official Role:	Study Director
Responsible Party Name/Official Title:	Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization:	GSK Clinical Disclosure
Location and Contact Information:	Click to view location information Finland (click to view all sites in Finland) GSK Investigational Site Kotka, 48100; Completed; GSK Investigational Site Tampere, 33200; Completed; GSK Investigational Site Rauma, 26100; Completed; GSK Investigational Site Kouvola, 45100; Completed; GSK Investigational Site Tampere, 33200; Completed; GSK Investigational Site Mikkeli, 50100; Completed;

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Protocol Summary for 580299/011