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HBV-MPL vaccine

Phase 3

Hepatitis B | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jun 17, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials3
Total Enrollment703

FDA Designations

No designations recorded

Clinical trial landscape

HBV-MPL vaccine · 3 trials · 1 indication

Phase 3 1Phase 2 2
NCT00696891Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in AdultsHepatitis B
COMPLETED380 Analytics
PHASE3COMPLETED
Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in Adults
Hepatitis BUnlock trial analytics

Study Endpoints

Primary Endpoints

Anti-HBs antibody concentrations
At Month 7

Secondary Endpoints

Anti-HBs antibody concentrations
At Months 1, 2, 6, 7 and 12
Occurrence and intensity of solicited local symptoms
4-day follow-up after vaccination
Occurrence and intensity and relationship to vaccination of solicited general symptoms
4-day follow-up after vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

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

Interventions

NameTypeDescription
HBV-MPL vaccineBIOLOGICAL3-dose intramuscular injection
Engerix™-BBIOLOGICAL3-dose intramuscular injection
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Eligibility Criteria

Age Range50 Years to 70 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Age: 50 to 70 years old. * Good physical condition as established by clinical examination and history taking at the time of entry. * Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period. * Written info...

Countries:BelgiumCanadaSwedenAustria
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Frequently asked questions about HBV-MPL vaccine

What is HBV-MPL vaccine used for?

HBV-MPL vaccine is an investigational vaccine being developed for the prevention of Hepatitis B. It is designed to be given to adults, with clinical trials evaluating its use in healthy volunteers aged 18 years and older. The vaccine is currently in Phase 3 clinical development.

Who makes HBV-MPL vaccine?

HBV-MPL vaccine is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in adult populations.

What phase is HBV-MPL vaccine in?

HBV-MPL vaccine is in Phase 3 clinical development. It has completed three clinical trials, including one Phase 3 study and two Phase 2 studies. The vaccine is investigational and has not been approved by regulatory authorities.

What clinical trials is HBV-MPL vaccine in?

HBV-MPL vaccine has completed three clinical trials. The Phase 3 trial, NCT00696891, compared the vaccine with Engerix-B in adults aged 50 years and older. Two Phase 2 trials, NCT00698555 and NCT00698906, evaluated different formulations in adults aged 18-40 and 19-40 years, respectively.

Is HBV-MPL vaccine the same as Engerix-B?

No, HBV-MPL vaccine is not the same as Engerix-B. Engerix-B is a comparator vaccine used in clinical trials to evaluate the safety and immunogenicity of HBV-MPL vaccine. The trials were designed to compare HBV-MPL vaccine with Engerix-B in adult populations.