GSK: Protocol Summary for 208129/032

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Protocol Summary for 208129/032

Protocol Summary
Protocol Id:	208129/032
Secondary Ids:
Title:	A phase III, clinical trial comparing the immunogenicity and safety of SmithKline Beecham Biologicals new adjuvanted hepatitis B vaccine to a double dose of Engerix™-B, 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:	Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years
Detailed Description:
Record Verification Date:	November 2009
Status:	Completed
Why Study Stopped:
Study Start Date:	December 1999
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 rates at Month 7.
Secondary Outcomes:	Solicited symptoms, unsolicited symptoms and serious adverse events
Conditions:	Hepatitis B
Keywords:
Eligibility Criteria:	Click to view inclusion/exclusion criteria Inclusion Criteria: •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. •Seronegative for anti-HBs antibodies, anti-HBc antibodies & Hepatitis B Surface antigen (HBsAg). •If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she had to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination. •Pre-haemodialysis patient* or a patient on haemodialysis. Exclusion Criteria: •Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine. •Previous vaccination against hepatitis B. •History of hepatitis B infection. •Known exposure to hepatitis B virus within 6 weeks. Pregnant or lactating female •Clinically abnormal ALT/AST values (> 3 times normal values)
Gender:	Both
Minimum Age:	15 Years
Maximum Age:	N/A
Enrollment:	165
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:	No locations currently recruiting for this study.

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Protocol Summary for 208129/032