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Liquid CAIV-T

Phase 3

Influenza | Small molecule | Infectious Disease |AstraZeneca PLC|Last Updated: Sep 13, 2021

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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment8,500
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00128167Trivalent, Live, Cold Adapted Influenza Vaccine (CAIV-T) Against Inactivated Influenza Vaccine (TIV) in Children 6-59 Months of AgePHASE3 COMPLETED 8,500Oct 1, 2004Dec 1, 2005Sep 13, 2021161 United States, Belgium +6
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Study Endpoints
Primary Endpoints
The primary efficacy endpoint of this study is the relative efficacy of CAIV-T
compared to TIV against the incidence of culture-confirmed symptomatic influenza infection caused by community-acquired wild-type strains antigenically similar to those contained in the vaccine, occurring during the
influenza surveillance period and at least 14 days after the last required vaccination
Secondary Endpoints
Culture-confirmed symptomatic influenza infection regardless of antigenic match
Febrile acute otitis media (AOM) with antibiotic use associated with culture-confirmed influenza infection antigenically similar to vaccine strains
Febrile acute otitis media (AOM) with antibiotic use associated with culture-confirmed influenza infection regardless of antigenic match
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposePREVENTION
Interventions
NameTypeDescription
Liquid CAIV-TDRUG -
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Eligibility Criteria
Age Range6 Months — 59 Months
SexALL
Healthy VolunteersYes
Study Sites161

Inclusion Criteria: * Age 6-59 months of age (not yet reached their 5th birthday) * Parent or guardian available by telephone * Available for illness visits at clinic or at home during the influenza surveillance period * Written informed consent (and Health Insurance Portability and Accountability ...

Countries:United StatesBelgiumCzechiaHong KongIrelandSouth KoreaTaiwanUnited Kingdom
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