Back to resultsImmunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs).
Primary Purpose
Hepatitis B
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
HBV-MPL vaccine 208129
Engerix™-B
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B focused on measuring Hepatitis B, Recombinant hepatitis B vaccine, Adjuvanted hepatitis B vaccine
Eligibility Criteria
Inclusion Criteria:
- Age: between 15 and 40 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 aged between 18 and 40 and from the parents/tutor when the subjects are aged between 15 and 17 years.
Exclusion Criteria:
- Positive titres at screening for anti-HBs 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 hepatitis B vaccine.
- Previous vaccination with an MPL containing vaccine.
- Administration of immunoglobulins in the past 6 months and during the whole study period
- Simultaneous 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
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, intensity and relationship to vaccination of solicited local and general symptoms
Occurrence, intensity and relationship to vaccination of unsolicited symptoms
Occurrence and relationship to vaccination of Serious Adverse Events (SAEs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00697216
Brief Title
Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs).
Official Title
Study Comparing the Immunogenicity and Reactogenicity of GSK Biologicals' HBV-MPL Vaccine Injected According to a 0, 6 Months Schedule With That of Engerix™-B Injected as a 0, 1, 6 Months Schedule in a Healthy Adult Population (15-40 Years)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
March 1997 (undefined)
Primary Completion Date
March 1999 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This study evaluates the safety and immunogenicity of the candidate HBV-MPL vaccine administered to healthy adults aged from 15 to 40 years, according to a 0, 6- month vaccination schedule, with Engerix™-B as control administered at 0, 1, 6 months.
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
Hepatitis B, Recombinant hepatitis B vaccine, Adjuvanted hepatitis B vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
340 (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 208129
Intervention Description
2-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
Month 7
Secondary Outcome Measure Information:
Title
Anti-HBs antibody concentrations
Time Frame
At months 1, 2, 6, 7 and 12
Title
Occurrence, intensity and relationship to vaccination of solicited local and general symptoms
Time Frame
4-day follow-up period after vaccination
Title
Occurrence, intensity and relationship to vaccination of unsolicited symptoms
Time Frame
31-day follow-up after vaccination
Title
Occurrence and relationship to vaccination of Serious Adverse Events (SAEs)
Time Frame
During the study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age: between 15 and 40 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 aged between 18 and 40 and from the parents/tutor when the subjects are aged between 15 and 17 years.
Exclusion Criteria:
Positive titres at screening for anti-HBs 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 hepatitis B vaccine.
Previous vaccination with an MPL containing vaccine.
Administration of immunoglobulins in the past 6 months and during the whole study period
Simultaneous 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
Brussels
Country
Belgium
Facility Name
GSK Clinical Trials Call Center
City
Copenhagen
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs).
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