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HBsAg formulated with different concentrations of MPL and Aluminium Salts

Phase 3

Hepatitis B | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jun 16, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment321

FDA Designations

No designations recorded

Clinical trial landscape

HBsAg formulated with different concentrations of MPL and Aluminium Salts · 1 trial · 1 indication

Phase 3 1
NCT00697970Evaluation of Immunogenicity and Reactogenicity of Various Formulations of Recombinant Hepatitis B VaccineHepatitis B
COMPLETED321 Analytics
PHASE3COMPLETED
Evaluation of Immunogenicity and Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine
Hepatitis BUnlock trial analytics

Study Endpoints

Primary Endpoints

Anti-HBs antibody concentrations
After two doses and after the booster dose

Secondary Endpoints

Occurrence and intensity of local and general solicited symptoms
8 days after vaccination
Anti-HBs antibody concentrations
Screening, M1, 2, 3, 4, 6, 12, 13
Occurrence of unsolicited adverse events
30-day after vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTAL -
Group BEXPERIMENTAL -
Group CEXPERIMENTAL -
Group DEXPERIMENTAL -
Group EEXPERIMENTAL -
Group FACTIVE_COMPARATOR -

Interventions

NameTypeDescription
HBsAg formulated with different concentrations of MPL and Aluminium SaltsBIOLOGICALIntramuscular injection, 3 doses
Engerix™-BBIOLOGICALIntramuscular injection, 3 doses
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Between 18 and 40 years old. * Written informed consent will have been obtained from the subjects. * Good physical condition as established by physical examination and history taking at the time of entry. * Female participants will avoid becoming pregnant during the study peri...

Countries:Austria
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