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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00697970 |
The purpose of the present trial is to evaluate 6 vaccine formulations of recombinant hepatitis B vaccine for their reactogenicity and immunogenicity when administered at 0-2 months with a booster at month 12
Condition | Intervention | Phase |
---|---|---|
Hepatitis B |
Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts 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 Evaluate the Immunogenicity and Reactogenicity of Various Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccine in Healthy Adult Volunteers |
Enrollment: | 321 |
Study Start Date: | November 1993 |
Study Completion Date: | April 1995 |
Primary Completion Date: | April 1995 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group A: Experimental |
Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts
Intramuscular injection, 3 doses
|
Group B: Experimental |
Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts
Intramuscular injection, 3 doses
|
Group C: Experimental |
Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts
Intramuscular injection, 3 doses
|
Group D: Experimental |
Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts
Intramuscular injection, 3 doses
|
Group E: Experimental |
Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts
Intramuscular injection, 3 doses
|
Group F: Active Comparator |
Biological: Engerix™-B
Intramuscular injection, 3 doses
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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: | 208129/006 |
Study First Received: | June 12, 2008 |
Last Updated: | June 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00697970 |
Health Authority: | Belgium: Institutional Review Board |
Hepatitis B Engerix™-B Recombinant Hepatitis B vaccine Adjuvant |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases |
Hepatitis B Hepatitis, Viral, Human DNA Virus Infections Healthy |
Hepadnaviridae Infections |