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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00697216 |
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Date of registration:
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11/06/2008 |
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Primary sponsor: |
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Public title:
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Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs).
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Scientific title:
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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) |
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Date of first enrolment:
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March 1997 |
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Target sample size:
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340 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00697216 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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Belgium
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Denmark
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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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
Age minimum:
15 Years
Age maximum:
40 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hepatitis B
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Intervention(s)
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Biological: Engerix™-B
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Biological: HBV-MPL vaccine 208129
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Primary Outcome(s)
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Anti-HBs antibody concentrations
[Time Frame: Month 7]
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Secondary Outcome(s)
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Anti-HBs antibody concentrations
[Time Frame: At months 1, 2, 6, 7 and 12]
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Occurrence and relationship to vaccination of Serious Adverse Events (SAEs)
[Time Frame: During the study period]
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Occurrence, intensity and relationship to vaccination of solicited local and general symptoms
[Time Frame: 4-day follow-up period after vaccination]
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Occurrence, intensity and relationship to vaccination of unsolicited symptoms
[Time Frame: 31-day follow-up after vaccination]
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Secondary ID(s)
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208129/027
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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