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Hepatitis A vaccine AVAXIM 80U

Phase 3

Hepatitis A | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Jan 22, 2014

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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment720
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00483470Immunogenicity and Safety of Sanofi Pasteur's AVAXIM 80U Pediatric Vaccine Followed by Booster DosePHASE3 COMPLETED 720Jun 1, 2007Aug 1, 2008Jan 22, 20143 China
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Study Endpoints
Primary Endpoints
To provide information concerning the immunogenicity of AVAXIM 80U Pediatric vaccine
1 month post-vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Hepatitis A vaccine AVAXIM 80UBIOLOGICAL0.5 mL, Intramuscular
Hepatitis A vaccine (HAVRIX 720)BIOLOGICAL0.5 mL, Intramuscular
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Eligibility Criteria
Age Range12 Months — 15 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria : Inclusion criteria to be checked at the screening visit (SC): 1. Toddlers, children and adolescents: Sub-Group 1: from 12 months to 3 years of age on the day of inclusion Sub-Group 2: from 4 to 6 years of age on the day of inclusion Sub-Group 3: from 7 to 9 years o...

Countries:China
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