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Combined Hepatitis A and B vaccine

Phase 3

Hepatitis B | Vaccine | Infectious Disease |GSK plc|Trials Updated: Sep 7, 2016

Combined Hepatitis A and B vaccine development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Sep 2005

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment143

FDA Designations

No designations recorded

Combined Hepatitis A and B vaccine clinical trials

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 BUnlock trial analytics

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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Frequently asked questions about Combined Hepatitis A and B vaccine

What is the combined hepatitis A and B vaccine?

The combined hepatitis A and B vaccine is an investigational vaccine developed by GSK plc that is designed to protect against both hepatitis A and hepatitis B in a single product. It is being studied in a Phase 3 clinical program, with hepatitis B listed as its primary indication and hepatitis A also evaluated in its trials.

What is the combined hepatitis A and B vaccine used for?

The combined hepatitis A and B vaccine is intended for immunization against hepatitis A and hepatitis B virus infection. GSK plc is developing it as a single vaccine covering both viruses, and its completed Phase 3 study enrolled healthy volunteers aged 12 years and older in Australia who received the combined vaccine.

Who makes the combined hepatitis A and B vaccine?

GSK plc, which trades under the ticker GSK, is the developer of the combined hepatitis A and B vaccine. The company sponsored the Phase 3 study of the vaccine, and GSK holds the program as part of its infectious disease vaccine portfolio.

What phase is the combined hepatitis A and B vaccine in?

The combined hepatitis A and B vaccine is in Phase 3 development. It is an investigational vaccine and is not described as approved. One Phase 3 trial has been completed, and no trials are currently listed as active for this program.

What clinical trials is the combined hepatitis A and B vaccine in?

The combined hepatitis A and B vaccine has been studied in 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. It enrolled 143 participants in Australia, aged 12 years and older, including healthy volunteers.

Was the combined hepatitis A and B vaccine trial randomized?

Yes, the Phase 3 trial of the combined hepatitis A and B vaccine, NCT00197171, was randomized. It was not double blinded and used an uncontrolled design, and it enrolled 143 participants. The study has been completed and compared two vaccination schedules of the combined vaccine.