- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00697853
Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine (2 Doses), and of Engerix™-B (3 Doses) in Healthy Adults
June 13, 2008 updated by: GlaxoSmithKline
Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' Novel Adjuvanted Hepatitis B Vaccine Administered According to a 0, 6 Month Schedule and of Engerix™-B Administered According to a 0, 1, 6 Month Schedule in Healthy Adults
This study is undertaken to assess the immune response and safety profile of 4 lots of the novel adjuvanted hepatitis B vaccine that were formulated following different processes, with Engerix™-B as the control vaccine
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is an open, randomized study with five groups, but the four groups receiving HBV-MPL candidate vaccine are double-blinded.
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Brussels, Belgium
- GSK Clinical Trial Call Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 50 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- A male or female between 15 and 50 years of age at the time of the first vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Written informed consent obtained from the subject and/or from the parents or guardians of the subject.
- If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to vaccination 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(s) during the study period or within 30 days preceding the first dose of study vaccine.
- Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
- Previous vaccination against hepatitis B.
- History of significant and persisting hematological, hepatic, renal, cardiac or respiratory disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute disease at the time of enrollment.
- Hepatomegaly, right upper quadrant abdominal pain or tenderness.
- Oral temperature of ≥37.5°C (99.5°F).
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period.
- Pregnant or lactating female.
- History of chronic alcohol consumption and/or intravenous drug abuse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group B
|
2-dose intramuscular injection
|
Experimental: Group C
|
2-dose intramuscular injection
|
Experimental: Group D
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2-dose intramuscular injection
|
Experimental: Group E
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2-dose intramuscular injection
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Active Comparator: Group A
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3-dose intramuscular injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Anti-HBs antibody concentrations
Time Frame: At month 7
|
At month 7
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence and intensity of solicited local and general symptoms
Time Frame: 4-day follow-up period after each vaccination
|
4-day follow-up period after each vaccination
|
Anti-HBs antibody concentrations
Time Frame: At months 1, 2 and 6
|
At months 1, 2 and 6
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Occurrence, intensity and relationship to vaccination of unsolicited symptoms
Time Frame: 30-day follow-up period after each vaccination
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30-day follow-up period after each vaccination
|
Occurrence, intensity and relationship to vaccination of SAEs
Time Frame: Throughout the entire study
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Throughout the entire study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 1998
Primary Completion (Actual)
July 1, 1999
Study Registration Dates
First Submitted
June 12, 2008
First Submitted That Met QC Criteria
June 13, 2008
First Posted (Estimate)
June 16, 2008
Study Record Updates
Last Update Posted (Estimate)
June 16, 2008
Last Update Submitted That Met QC Criteria
June 13, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 208129/030
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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