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MPL-Adjuvanted recombinant hepatitis B vaccine

Phase 3

Hepatitis B | Vaccine | Infectious Disease |GSK plc|Trials Updated: Jun 16, 2008

MPL-Adjuvanted recombinant hepatitis B vaccine development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Jun 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

MPL-Adjuvanted recombinant hepatitis B vaccine clinical trials

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?

It is an investigational hepatitis B vaccine developed by GSK plc that combines a recombinant hepatitis B antigen with the MPL adjuvant. It is designed to prevent hepatitis B infection and is being studied in a Phase 3 clinical program.

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

It is being developed for the prevention of hepatitis B, an infectious disease of the liver. The vaccine is intended to induce protective immunity against hepatitis B virus and is in Phase 3 clinical development.

Who makes MPL-Adjuvanted recombinant hepatitis B vaccine?

GSK plc, which trades under the ticker GSK, is the developer of the MPL-Adjuvanted recombinant hepatitis B vaccine. The company is responsible for the clinical development program for this vaccine candidate.

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 by the FDA. The Phase 3 trial has been completed.

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

The vaccine has been studied in one completed Phase 3 trial, NCT00698087, titled Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix-B. The trial enrolled 60 healthy adult volunteers in Austria and was randomized, double-blind, and active-controlled.