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Combined Hepatitis A and B vaccine

Phase 3

Hepatitis B | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Sep 7, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment143

FDA Designations

No designations recorded

Clinical trial landscape

Combined Hepatitis A and B vaccine · 1 trial · 2 indications

Phase 3 1
NCT00197171Long Term F/U Studies at Y5&6 to Demonstrate the Equivalence of 2 Vaccination Schedules of Combined Hepatitis A & B VaccineHepatitis B
COMPLETED143 Analytics
PHASE3COMPLETED
Long Term F/U Studies at Y5&6 to Demonstrate the Equivalence of 2 Vaccination Schedules of Combined Hepatitis A & B Vaccine
Hepatitis B
NCT00197171143
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Study Endpoints

Primary Endpoints

Immune persistence in terms of anti-HAV and anti-HBs antibodies and GMCs, 5 and 6 years after administration of first vaccine dose. An additional dose of the study vaccine will be given (between 6 to 12 months after the Year 6 time point) to subjects who

Secondary Endpoints

To record the SAEs that was reported since the last time point.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Combined Hepatitis A and B vaccineBIOLOGICAL -
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Eligibility Criteria

Age Range12 Years to 15 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Subjects who received GSK Biologicals' combined hepatitis A and B vaccine in the primary study (HAB-082). Subjects were aged 12 to 15 years at the time of the first vaccination.

Countries:Australia
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Competitive Landscape -Hepatitis B 30 trials

CompanyTickerTrialsLead PhaseDrugs
Gilead Sciences, Inc.GILD3PHASE3Tenofovir DF
Vir Biotechnology, Inc.VIR6PHASE3Tobevibart, Elebsiran
Bausch Health Companies Inc.BHC1PHASE3Larsucosterol
GSK plc Sponsored ADRGSK4PHASE2Daplusiran/Tomligisiran Dose Level 1, Bepirovirsen
Aligos Therapeutics, Inc.ALGS1PHASE2ALG-000184, TDF
Precision BioSciences, Inc.DTIL2PHASE1PBGENE-HBV
Exact Sciences CorporationEXAS1 - Undisclosed
AbbVie, Inc.ABBV1 - Undisclosed
Healthcare Services Group, Inc.HCSG1 - Undisclosed
Plus Therapeutics, Inc.PSTV1N/AUndisclosed
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Frequently asked questions about Combined Hepatitis A and B vaccine

What is Combined Hepatitis A and B vaccine used for?

Combined Hepatitis A and B vaccine is used for the prevention of Hepatitis B and Hepatitis A infections. It is an investigational vaccine being developed by GSK plc for active immunization against these viral diseases. The vaccine is currently in Phase 3 clinical development.

Who makes Combined Hepatitis A and B vaccine?

GSK plc (ticker: GSK) is the developer of Combined Hepatitis A and B vaccine. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity for the prevention of Hepatitis A and Hepatitis B infections.

What phase is Combined Hepatitis A and B vaccine in?

Combined Hepatitis A and B vaccine is in Phase 3 clinical development. It is an investigational vaccine, not yet approved by regulatory authorities. One Phase 3 trial has been completed to evaluate the equivalence of two vaccination schedules.

What clinical trials is Combined Hepatitis A and B vaccine in?

Combined Hepatitis A and B vaccine has one completed Phase 3 trial, NCT00197171, titled 'Long Term F/U Studies at Y5&6 to Demonstrate the Equivalence of 2 Vaccination Schedules of Combined Hepatitis A & B Vaccine'. The trial enrolled 143 participants in Australia and was an uncontrolled, randomized study.

How does Combined Hepatitis A and B vaccine work?

Combined Hepatitis A and B vaccine is a monoclonal antibody modality. It is designed to provide protection against Hepatitis A and Hepatitis B by stimulating the immune system to produce antibodies against these viruses. The vaccine combines antigens from both viruses to elicit a protective immune response.