Recent Updates
Recently added Catalysts

CAIV-T or TIV

Phase 3

Respiratory Tract Infections | Monoclonal antibody | Other |AstraZeneca PLC|Last Updated: Oct 3, 2006

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment2,200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00192205Trial to Compare the Safety,Tolerability and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Influenza Virus Vaccine, Trivalent, Inactivated (TIV) in ChildrenPHASE3 COMPLETED 2,200 — — Oct 1, 2002Jun 1, 2003Oct 3, 20062 Israel, Spain
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
To demostrate that the efficacy over one season against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the vaccine
Secondary Endpoints
To demostrate that the efficacy over one season of CAIV-T is not inferior to that of TIV against culture-confirmed influenza-illness of any subtype
To demonstrate that the efficacy of CAIV-T is not inferior to that of TIV against clinically-defined acute otitis media
To compare the rate of occurence over a defined surveillance period in children with a histroy of recurrent RTIs
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
CAIV-T or TIVBIOLOGICAL -
Unlock Study Design Details
Eligibility Criteria
Age Range6 Months — 71 Months
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * who are aged at least 6 months and less than 72 months of age at the time of enrolment; * who have experienced two or more practitioner attended RTIs\* in the past 12 months (since birth if less than 12 months old); \* RTIs are defined as upper RTIs including (but not limited ...

Countries:IsraelSpain
Unlock Eligibility Criteria