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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: |
NCT00197158 |
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Date of registration:
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15/09/2005 |
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Primary sponsor: |
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Public title:
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Comparison of Monodose and Multidose Presentations of GSK Biologicals' Hepatitis B Vaccine in Terms of Immune Response
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Scientific title:
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Demonstrate the Non-inferiority of Immunogenicity Elicited by GSK Biologicals' Hepatitis B Vaccine, Multidose Engerix™-B to That of Monodose Engerix™-B When Administered According to 0,1,6 Mths Schedule in Healthy Adults Aged = 18 Yrs |
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Date of first enrolment:
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March 2005 |
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Target sample size:
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280 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00197158 |
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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: Single Blind, Primary Purpose: Prevention
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Countries of recruitment
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Belgium
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Contacts
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Name:
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GSK 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:
- A male or female >= 18 years of age
- Written informed consent obtained from the subject.
- Free of obvious health problems as established by medical history and clinical
examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential, i.e. either
surgically sterilized or one year post-menopausal; or, if of childbearing potential,
she must be abstinent or have used adequate contraceptive precautions for 30 days
prior to vaccination, have a negative pregnancy test and must agree to continue such
precautions for two months after completion of the vaccination series.
Exclusion criteria:
- Use of any investigational or non-registered drug or vaccine other than the study
vaccine during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within six months prior to the first vaccine dose. (For
corticosteroids, this will mean prednisone, or equivalent, greater than or equal to
0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- Planned administration/ administration of a vaccine not foreseen by the study
protocol within 30 days of the first dose of vaccine.
- Previous vaccination against hepatitis B
- History of hepatitis B infection
- Known exposure to hepatitis B within the previous 6 weeks
- 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(s).
- Acute disease at the time of enrolment. (Acute disease is defined as the presence of
a moderate or severe illness with or without fever. All vaccines can be administered
to persons with a minor illness such as diarrhoea, mild upper respiratory infection
with or without low-grade febrile illness, i.e. Oral temperature < 37.5°C (99.5°F) /
Axillary temperature <37.5°C (99.5°F).
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
functional abnormality, as determined by physical examination or laboratory screening
tests.
- Administration of immunoglobulins and/or any blood products within the three months
preceding the first dose of study vaccine or planned administration during the study
period. Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive
precautions during the study period.
Age minimum:
18 Years
Age maximum:
N/A
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: Hepatitis B vaccine
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Primary Outcome(s)
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Measurement of antibody concentrations to hepatitis B antigen at Month 7.
[Time Frame: No]
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Secondary Outcome(s)
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Measurement of antibody concentrations to hepatitis antigen at Months 1,2and6. Occurrence of solicited local symptoms and solicited general symptoms during the 4-day f/u period after vaccination. Occurrence, intensity and relationship to vaccination
[Time Frame: No]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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