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Hepatitis B adjuvanted vaccine

Phase 3

Hepatitis B | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Mar 23, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials3
Total Enrollment426

FDA Designations

No designations recorded

Clinical trial landscape

Hepatitis B adjuvanted vaccine · 3 trials · 1 indication

Phase 3 3
NCT00383591Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 YearsHepatitis B
COMPLETED120 Analytics
NCT00383227Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 YearsHepatitis B
COMPLETED165 Analytics
NCT00383383Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 YearsHepatitis B
COMPLETED141 Analytics
PHASE3COMPLETED
Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years
Hepatitis BUnlock trial analytics
PHASE3COMPLETED
Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years
Hepatitis BUnlock trial analytics
PHASE3COMPLETED
Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years
Hepatitis BUnlock trial analytics

Study Endpoints

Primary Endpoints

Anti-HBs seroprotection
Response to booster
Anti-HBs seroprotection rates at Month 7.
Anti-HBs seroprotection rates at Month 12.

Secondary Endpoints

Solicited, unsolicited symptoms and serious adverse events
Solicited symptoms, unsolicited symptoms and serious adverse events
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Hepatitis B adjuvanted vaccineBIOLOGICAL -
Engerix-BBIOLOGICAL -
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Eligibility Criteria

Age Range15 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Subjects were to have completed primary vaccination course. A male or female \> = 15 years of age at the time of the first vaccination. * Written informed consent obtained from the subject/ from the parents or guardians of the subject. * If the subject was a female, she was of...

Countries:CzechiaMalaysiaSpain
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Frequently asked questions about Hepatitis B adjuvanted vaccine

What is Hepatitis B adjuvanted vaccine used for?

Hepatitis B adjuvanted vaccine is an investigational vaccine being developed for the prevention of Hepatitis B. It is currently in Phase 3 clinical development, with studies conducted in pre- and haemodialysis patients aged 15 years and older. The vaccine is designed to provide protection against Hepatitis B infection.

Who makes Hepatitis B adjuvanted vaccine?

Hepatitis B adjuvanted vaccine is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting Phase 3 clinical trials to evaluate the vaccine's safety and efficacy in preventing Hepatitis B.

What phase is Hepatitis B adjuvanted vaccine in?

Hepatitis B adjuvanted vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. Three Phase 3 trials have been completed, with a total enrollment of 426 participants.

What clinical trials is Hepatitis B adjuvanted vaccine in?

Hepatitis B adjuvanted vaccine has been studied in three completed Phase 3 trials: NCT00383227, NCT00383383, and NCT00383591. These trials compared the adjuvanted vaccine to a double dose of Engerix-B in pre- and haemodialysis patients aged 15 years and older.

Is Hepatitis B adjuvanted vaccine the same as Engerix-B?

No, Hepatitis B adjuvanted vaccine is not the same as Engerix-B. In clinical trials, the adjuvanted vaccine was compared to a double dose of Engerix-B, which is a standard Hepatitis B vaccine. The adjuvanted vaccine is a separate investigational product being developed by GSK.