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Adjuvanted and un-adjuvanted influenza vaccines

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Jan 24, 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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment410
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00848887A Dose Ranging Study Comparing Different Combinations of Adjuvanted and Non-adjuvanted Influenza Vaccines in Healthy Children 6 to <36 Months of AgePHASE1 COMPLETED 410Oct 1, 2008May 1, 2009Jan 24, 20141 Belgium
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Study Endpoints
Primary Endpoints
Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.
50 days
Secondary Endpoints
Strain-specific influenza antibody titers will be used to assess Immunogenicity
50 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelFACTORIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
Adjuvanted and un-adjuvanted influenza vaccinesBIOLOGICAL16 different formulations of trivalent influenza vaccine and 1 marketed influenza vaccine comparator.
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Eligibility Criteria
Age Range6 Months — 35 Months
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Children of 6 month to \<36 month of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator. Exclusion Criteria: * History of serious disease. History of serious reaction following administration of vaccine or hype...

Countries:Belgium
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