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Euvax B: Hepatitis B vaccine

Phase 3

Hepatitis B | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Apr 6, 2022

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02697474Anti-Hep B Antibodies at Age 9 to 10 Years After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine.PHASE3 COMPLETED 150Feb 1, 2016Jan 1, 2017Apr 6, 20222 Thailand
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Study Endpoints
Primary Endpoints
Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study
Day 0 (pre-vaccination)
Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study following vaccination with Euvax B® vaccine
Day 28 (post-vaccination)
Secondary Endpoints
Number of subjects reporting Serious Adverse Events and relatedness to study vaccine throughout the study
Day 0 up to Day 28 post-vaccination
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Hexaxim® GroupEXPERIMENTALSubjects that received Hexaxim® in Study A3L12
Infanrix® hexa GroupEXPERIMENTALSubjects that received Infanrix® hexa in Study A3L12
Interventions
NameTypeDescription
Euvax B®: Hepatitis B vaccineBIOLOGICAL0.5 mL, Intramuscular
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Eligibility Criteria
Age Range9 Years — 10 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Informed consent form signed by subject's parent/legally acceptable representative * Assent form signed by subject * Subject and parent(s)/legally acceptable representatives able to attend the scheduled visits and to comply with all trial procedures * Receipt of primary vaccin...

Countries:Thailand
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