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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLED
Total Trials3
Total Enrollment426
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00383591Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 YearsPHASE3 COMPLETED 120Mar 1, 2002Jan 1, 2004Mar 23, 20175 Czechia, Malaysia +1
NCT00383227Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 YearsPHASE3 COMPLETED 165Dec 1, 1999Nov 1, 2000Sep 16, 2016 -
NCT00383383Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 YearsPHASE3 COMPLETED 141Dec 1, 1999 -Oct 3, 20063 Czechia, Malaysia +1
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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 — 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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