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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00698087 |
The purpose of the study is to compare the safety, reactogenicity and immunogenicity of different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B when administered at 0, 2 months with a booster at month 12 if necessary
Condition | Intervention | Phase |
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Hepatitis B |
Biological: MPL-Adjuvanted recombinant hepatitis B vaccine Biological: Engerix™-B |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Study to Compare the Safety, Immunogenicity and Reactogenicity of Different Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B |
Enrollment: | 60 |
Study Start Date: | January 1995 |
Study Completion Date: | February 1996 |
Primary Completion Date: | February 1996 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A: Experimental |
Biological: MPL-Adjuvanted recombinant hepatitis B vaccine
Intramuscular injection, 2 or 3 doses, 2 different formulations
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Group B: Active Comparator |
Biological: Engerix™-B
Intramuscular injection, 2 or 3 doses
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Group C: Experimental |
Biological: MPL-Adjuvanted recombinant hepatitis B vaccine
Intramuscular injection, 2 or 3 doses, 2 different formulations
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At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Isabelle Harpigny ) |
Study ID Numbers: | 208129/016 |
Study First Received: | June 12, 2008 |
Last Updated: | June 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00698087 |
Health Authority: | Austria: Ethikkommission |
Hepatitis B Engerix™-B Adjuvanted recombinant hepatitis B vaccine |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases |
Hepatitis B Hepatitis, Viral, Human DNA Virus Infections |
Hepadnaviridae Infections |