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Chimeric dengue serotype

Phase 2

Dengue | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Feb 27, 2018

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment35
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00730288Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult SubjectsPHASE2 COMPLETED 35Aug 1, 2006Jan 1, 2008Feb 27, 20181 Australia
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Study Endpoints
Primary Endpoints
Immunogenicity: To provide information concerning the immunogenicity of ChimeriVax™
28, 60 and 180 days post vaccination
Safety: To provide information concerning the safety of ChimeriVax™
28 days post-vaccination and entire study duration
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTALReceived monovalent Vero dengue vaccine in Study DIV12
2EXPERIMENTALReceived Yellow fever vaccine in Study DIV12
3EXPERIMENTALFlavivirus-naive subjects
Interventions
NameTypeDescription
Chimeric dengue serotype (1, 2, 3, 4)BIOLOGICAL0.5 mL, Subcutaneous, 1 dose
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria : * Aged 18 to 40 years on the day of inclusion. * Informed consent form signed. * For a woman, inability to bear a child or negative serum pregnancy test. * Completed the one-year follow-up of Study DIV12. * Able to attend all scheduled visits and to comply with all trial proced...

Countries:Australia
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