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HBVaxPRO 5 µg /

Phase 3

Hepatitis B | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Sep 11, 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
RandomizedCONTROLLED
Total Trials1
Total Enrollment410
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00693186A Study to Assess the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children After a Primary Vaccination Series With Either HEXAVAC® or INFANRIX®-HEXAPHASE3 COMPLETED 410Oct 1, 2008Mar 1, 2010Sep 11, 20175 Italy
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Study Endpoints
Primary Endpoints
Percentage of subjects with anti-HBs antibody titres >=10 mIU/mL measured at 1 month post-booster dose
28 to 42 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
Interventions
NameTypeDescription
HBVaxPRO® 5 µg / 0.5 mLBIOLOGICAL5 µg / 0.5 mL
Engerix B® 10 µg / 0.5 mLBIOLOGICAL10 µg
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Eligibility Criteria
Age Range4 Years — 7 Years
SexALL
Healthy VolunteersYes
Study Sites5

Inclusion Criteria: * Healthy child of 4 to 7 years of age of either gender, * Child vaccinated with 2 doses of HEXAVAC® during the first 6 months of life and with a 3rd dose of HEXAVAC® before the end of the second year of life or Child vaccinated with 2 doses of INFANRIX®-HEXA during the first 6 ...

Countries:Italy
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