Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in Adults
Primary Purpose
Hepatitis B
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
HBV-MPL vaccine
Engerix™-B
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B focused on measuring Adjuvanted hepatitis B vaccine, hepatitis B, Engerix™-B
Eligibility Criteria
Inclusion Criteria:
- Age: 50 to 70 years old.
- Good physical condition as established by clinical examination and history taking at the time of entry.
- Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.
- Written informed consent obtained from the subjects
Exclusion Criteria:
- Positive at screening for anti-HBV antibodies.
- Elevated serum liver enzymes
- History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
- Any acute disease at the moment of entry.
- Chronic alcohol consumption.
- Hepatomegaly, right upper quadrant abdominal pain or tenderness.
- Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study.
- History of allergic disease likely to be stimulated by any component of the vaccine.
- Simultaneous participation in any other clinical trial.
- Previous vaccination with a recombinant hepatitis B vaccine.
- Previous vaccination with an MPL containing vaccine.
- Administration of immunoglobulins in the past 6 months and during the whole study period
- Vaccination one week before and one week after each dose of the study vaccine
Sites / Locations
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Outcomes
Primary Outcome Measures
Anti-HBs antibody concentrations
Secondary Outcome Measures
Anti-HBs antibody concentrations
Occurrence and intensity of solicited local symptoms
Occurrence and intensity and relationship to vaccination of solicited general symptoms
Occurrence and intensity of any symptoms (solicited/ unsolicited).
Occurrence, intensity and causal relationship of unsolicited symptoms
Serious adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00696891
Brief Title
Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in Adults
Official Title
Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine With That of Engerix™-B When Both Are Injected According to 3 Dose Schedule (0, 1, 6 Months) in an Adult Population Aged Between 50 and 70 Years
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
June 1997 (undefined)
Primary Completion Date
May 1999 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This study is conducted to compare the immunogenicity, reactogenicity and safety of Engerix™-B and HBV-MPL vaccine against hepatitis B infection in an elderly population
Detailed Description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
Adjuvanted hepatitis B vaccine, hepatitis B, Engerix™-B
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
380 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
HBV-MPL vaccine
Intervention Description
3-dose intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Engerix™-B
Intervention Description
3-dose intramuscular injection
Primary Outcome Measure Information:
Title
Anti-HBs antibody concentrations
Time Frame
At Month 7
Secondary Outcome Measure Information:
Title
Anti-HBs antibody concentrations
Time Frame
At Months 1, 2, 6, 7 and 12
Title
Occurrence and intensity of solicited local symptoms
Time Frame
4-day follow-up after vaccination
Title
Occurrence and intensity and relationship to vaccination of solicited general symptoms
Time Frame
4-day follow-up after vaccination
Title
Occurrence and intensity of any symptoms (solicited/ unsolicited).
Time Frame
4-day follow-up after vaccination
Title
Occurrence, intensity and causal relationship of unsolicited symptoms
Time Frame
Within 30 days after vaccination
Title
Serious adverse events
Time Frame
Throughout study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age: 50 to 70 years old.
Good physical condition as established by clinical examination and history taking at the time of entry.
Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.
Written informed consent obtained from the subjects
Exclusion Criteria:
Positive at screening for anti-HBV antibodies.
Elevated serum liver enzymes
History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
Any acute disease at the moment of entry.
Chronic alcohol consumption.
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study.
History of allergic disease likely to be stimulated by any component of the vaccine.
Simultaneous participation in any other clinical trial.
Previous vaccination with a recombinant hepatitis B vaccine.
Previous vaccination with an MPL containing vaccine.
Administration of immunoglobulins in the past 6 months and during the whole study period
Vaccination one week before and one week after each dose of the study vaccine
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
Wilrijk
Country
Belgium
Facility Name
GSK Clinical Trials Call Center
City
Toronto
Country
Canada
Facility Name
GSK Clinical Trials Call Center
City
Göteborg
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in Adults
We'll reach out to this number within 24 hrs