Back to resultsComparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years
Primary Purpose
Hepatitis B
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Hepatitis B adjuvanted vaccine
Engerix-B
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B
Eligibility 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)
Sites / Locations
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
Outcomes
Primary Outcome Measures
Anti-HBs seroprotection rates at Month 12.
Secondary Outcome Measures
Solicited symptoms, unsolicited symptoms and serious adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00383383
Brief Title
Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years
Official Title
To Compare the Immunogenicity & Safety of GSK Biologicals New Adjuvanted Hepatitis B Vaccine to a Double Dose of Engerix™-B, in Pre-Haemodialysis/Haemodialysis Patients (≥15 Years of Age)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
141 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Hepatitis B adjuvanted vaccine
Intervention Type
Biological
Intervention Name(s)
Engerix-B
Primary Outcome Measure Information:
Title
Anti-HBs seroprotection rates at Month 12.
Secondary Outcome Measure Information:
Title
Solicited symptoms, unsolicited symptoms and serious adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Clinical Trials Call Center
City
Hradec
State/Province
Králové
Country
Czech Republic
Facility Name
GSK Clinical Trials Call Center
City
Kuala Lumpur
Country
Malaysia
Facility Name
GSK Clinical Trials Call Center
City
Malaga
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years
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