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HBV-MPL vaccine Formulation A

Phase 2

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

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

HBV-MPL vaccine Formulation A · 1 trial · 1 indication

Phase 2 1
NCT00697775Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy AdolescentsHepatitis B
COMPLETED200 Analytics
PHASE2COMPLETED
Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents
Hepatitis BUnlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence of Serious adverse experiences (SAE)
During the study period
Occurrence, intensity and relationship to vaccination of solicited local and general symptoms
During the 8-day follow-up period after vaccination
Occurrence, intensity and causal relationship of unsolicited adverse events
31-day follow-up period after vaccination

Secondary Endpoints

Anti-HBs antibody concentrations
At months 1, 2, 6, and 7
Cell mediated immunity
At months 1, 6, and 7
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTALHBV-MPL Formulation A at months 0 and 6
Group BEXPERIMENTALHBV-MPL Formulation B at months 0 and 6
Group CEXPERIMENTALHBV-MPL Formulation A at month 0 and Engerix™-B at month 6
Group DACTIVE_COMPARATOREngerix™-B at months 0, 1, 6

Interventions

NameTypeDescription
HBV-MPL vaccine Formulation ABIOLOGICALSingle dose (when extemporaneously co-administered with Engerix™-B) or 2-dose (when administered alone) intramuscular injection
HBV-MPL vaccine Formulation BBIOLOGICAL2-dose intramuscular injection
Engerix™-BBIOLOGICALSingle dose (when extemporaneously co-administered with HBV-MPL) or 3-dose (when administered alone) intramuscular injection
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Eligibility Criteria

Age Range11 Years to 15 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Age: between 11 and 15 years at the time of the first vaccination. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Written informed consent obtained from the parents or guardians of the subject and ...

Countries:Germany
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Frequently asked questions about HBV-MPL vaccine Formulation A

What is HBV-MPL vaccine Formulation A used for?

HBV-MPL vaccine Formulation A is an investigational vaccine being studied for the prevention of Hepatitis B. It is currently in Phase 2 clinical development and is intended for use in healthy adolescents. The vaccine is being evaluated for its safety and immunogenicity compared to an active control.

Who makes HBV-MPL vaccine Formulation A?

HBV-MPL vaccine Formulation A is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in healthy adolescents for the prevention of Hepatitis B.

What phase is HBV-MPL vaccine Formulation A in?

HBV-MPL vaccine Formulation A is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the vaccine is being studied for its safety and immunogenicity in healthy adolescents for Hepatitis B.

What clinical trials is HBV-MPL vaccine Formulation A in?

HBV-MPL vaccine Formulation A has been studied in one completed Phase 2 clinical trial with the identifier NCT00697775. The trial, titled 'Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents,' enrolled 200 participants in Germany and was an active-controlled, randomized study.

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

No, HBV-MPL vaccine Formulation A is not the same as Engerix-B. Engerix-B is a licensed Hepatitis B vaccine that was used as an active control in the clinical trial for HBV-MPL vaccine Formulation A. The two vaccines are different products, and the trial compared the candidate vaccine against Engerix-B.