Last updated: 11/03/2018 00:34:36
Comparison of monodose and multidose presentations of GSK Biologicals' hepatitis B vaccine in terms of immune response
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: GSK Biologicals' currently licensed multidose hepatitis B vaccine will be compared to the currently licensed monodose hepatitis B vaccine in a population with well documented hepatitis B immunological response to the vaccine (Belgium).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Hepatitis B vaccine
Enrollment:
280
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B
Product
SKF103860
Collaborators
Not applicable
Study date(s)
March 2005 to December 2005
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- A male or female >= 18 years of age
- Written informed consent obtained from the subject.
- 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
Inclusion and exclusion criteria
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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-14-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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