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MPL-Adjuvanted recombinant hepatitis B vaccine

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 Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

MPL-Adjuvanted recombinant hepatitis B vaccine · 1 trial · 1 indication

Phase 3 1
NCT00698087Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-BHepatitis B
COMPLETED60 Analytics
PHASE3COMPLETED
Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B
Hepatitis BUnlock trial analytics

Study Endpoints

Primary Endpoints

Anti-HBs antibody concentrations
At M3 and M13
Occurrence of local and general solicited symptoms
4-day follow-up after vaccination
Occurrence of unsolicited symptoms
30-day follow-up after vaccination

Secondary Endpoints

SAEs
Throughout the study up to 30 days after last vaccination
Anti-HBs antibody concentrations
Months 2, 3, 6, 9, 12, 13
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTAL -
Group BACTIVE_COMPARATOR -
Group CEXPERIMENTAL -

Interventions

NameTypeDescription
MPL-Adjuvanted recombinant hepatitis B vaccineBIOLOGICALIntramuscular injection, 2 or 3 doses, 2 different formulations
Engerix™-BBIOLOGICALIntramuscular injection, 2 or 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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Frequently asked questions about MPL-Adjuvanted recombinant hepatitis B vaccine

What is MPL-Adjuvanted recombinant hepatitis B vaccine used for?

MPL-Adjuvanted recombinant hepatitis B vaccine is an investigational vaccine being studied for the prevention of Hepatitis B. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.

Who makes MPL-Adjuvanted recombinant hepatitis B vaccine?

MPL-Adjuvanted recombinant hepatitis B vaccine is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker symbol GSK.

What phase is MPL-Adjuvanted recombinant hepatitis B vaccine in?

MPL-Adjuvanted recombinant hepatitis B vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved for use outside of clinical trials.

What clinical trials is MPL-Adjuvanted recombinant hepatitis B vaccine in?

MPL-Adjuvanted recombinant hepatitis B vaccine has one completed Phase 3 trial, NCT00698087, which compared its safety, immunogenicity, and reactogenicity to Engerix-B in 60 healthy adults in Austria.

Is MPL-Adjuvanted recombinant hepatitis B vaccine the same as Engerix-B?

MPL-Adjuvanted recombinant hepatitis B vaccine is not the same as Engerix-B. It is a distinct investigational vaccine that was compared against Engerix-B as an active control in a clinical trial to evaluate its safety and immune response.