Comparison of Monodose and Multidose Presentations of GSK Biologicals' Hepatitis B Vaccine in Terms of Immune Response
This study has been completed.
Information provided by:
First received: September 15, 2005
Last updated: September 29, 2011
Last verified: September 2011
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).
Biological: Hepatitis B vaccine
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
||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
Primary Outcome Measures:
- Measurement of antibody concentrations to hepatitis B antigen at Month 7. [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2005 (Final data collection date for primary outcome measure)
Randomized study with two groups. One group will receive GSK's multidose hepatitis B vaccine and the other group will receive GSK's monodose hepatitis B vaccine
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00197158
|GSK Investigational Site
|Wilrijk, Belgium, 2610 |
||GSK Clinical Trials
No publications provided
||Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 15, 2005
||September 29, 2011
||Belgium: Federal Agency for Medicines and Health Products, FAMHP
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 10, 2014
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
DNA Virus Infections