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CAIV-T and TIV

Phase 3

Asthma | Monoclonal antibody | Respiratory |AstraZeneca PLC|Last Updated: Oct 3, 2006

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment2,229
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00192257Trial to Compare the Safety, Tolerability and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Influenza Virus in Children With AsthmaPHASE3 COMPLETED 2,229Oct 1, 2002May 1, 2003Oct 3, 20062 Belgium
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Study Endpoints
Primary Endpoints
To demostrate that the efficacy over one influenza season against culture-confirmed influenza illness caused by community-acquired subtypes antifenically similar to those contained in the vaccine
Secondary Endpoints
To demonstrate that the efficacy over one season of a single dose of CAIV-T was not inferior to that of one dose of TIV against culture-confirmed influenza-illness of any subtype
To compare the efficacy over a defined surveillance period against asthma exacerbations, asthma medication, clinical visits, hospitalizations, days off school (pharma-ecomonic measures) associated with influenza-like illness
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
CAIV-T and TIVBIOLOGICAL -
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Eligibility Criteria
Age Range6 Years — 17 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * who are aged at least 6 years to 17 years of age at the time of enrollment; * with a clinical diagnosis of asthma by one of the following criteria: * An International Classification of Diseases, Ninth revision (ICD-9) code 493 AND ≥one prescription for asthma medication; * OR ...

Countries:Belgium
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