GSK: Protocol Summary for 208129/047

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Protocol Summary for 208129/047

Protocol Summary
Protocol Id:	208129/047
Secondary Ids:
Title:	A phase III, clinical trial comparing the persistence of GSK Biologicals new adjuvanted hepatitis B vaccine to a double dose of Engerix™-B at months 24, 30, 36, in pre-haemodialysis/haemodialysis patients (≥15 years of age)
Phase:	Phase 3
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?:	No
Study Type:	Interventional
Oversight Authority:	Czech Republic: State Institute for Drug Control
Collaborators:
Brief Summary:	Persistence of anti-HBs antibodies at Month 24, 30 and 36 in subjects who had completed primary vaccination was evaluated. The anamnestic response to a booster dose was evaluated in subjects with anti-HBs antibody titres < 10 mIU/ml at previous timepoint. The study also evaluated the effect of a booster dose of the vaccine (Month 42) after primary vaccination.
Detailed Description:
Record Verification Date:	September 2009
Status:	Completed
Why Study Stopped:
Study Start Date:	March 2002
Study Completion Date:
Study Completion Date Type:
Primary Completion Date:
Primary Completion Date Type:
Primary Purpose:	Prevention
Allocation:	Randomized
Masking:	Open Label
Masked Subject:
Masked Caregiver:
Masked Investigator:
Masked Assessor:
Study Design (Assignment):	Parallel Assignment
Study Classification (Endpoint):	Safety/Efficacy Study
Primary Outcomes:	Anti-HBs seroprotection Response to booster
Secondary Outcomes:	Solicited, unsolicited symptoms and serious adverse events
Conditions:	Hepatitis B
Keywords:
Eligibility Criteria:	Click to view inclusion/exclusion criteria Inclusion Criteria: •Subjects were to have completed primary vaccination course. A male or female > = 15 years of age at the time of the first vaccination. •Written informed consent obtained from the subject/ from the parents or guardians of the subject. •If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she was to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination. Exclusion Criteria: •Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period. •Pregnant or lactating female.
Gender:	Both
Minimum Age:	15 Years
Maximum Age:	N/A
Enrollment:	120
Enrollment Type:
Healthy Volunteers?:	No
Central Contact:	US GSK Clinical Trials Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:	EU GSK Clinical Trials Call Center
Backup Central Contact Phone:	+44 (0) 20 8990 4466
Backup Central Contact Email:	GSKClinicalSupportHD@gsk.com
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 Czech Republic (click to view all sites in Czech Republic) GSK Investigational Site Hradec Kralove, , 500 01; Completed; Malaysia (click to view all sites in Malaysia) GSK Investigational Site Bandar Tun Razak, Cheras, , 56000; Completed; Spain (click to view all sites in Spain) GSK Investigational Site Madrid, , 28046; Completed; GSK Investigational Site Malaga, , 29010; Completed; GSK Investigational Site Barcelona, , 08036; Completed;

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Protocol Summary for 208129/047