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Liquid CAIV-T

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment8,500

FDA Designations

No designations recorded

Clinical trial landscape

Liquid CAIV-T · 1 trial · 1 indication

Phase 3 1
NCT00128167Trivalent, Live, Cold Adapted Influenza Vaccine (CAIV-T) Against Inactivated Influenza Vaccine (TIV) in Children 6-59 Months of AgeInfluenza
COMPLETED8,500 Analytics
PHASE3COMPLETED
Trivalent, Live, Cold Adapted Influenza Vaccine (CAIV-T) Against Inactivated Influenza Vaccine (TIV) in Children 6-59 Months of Age
InfluenzaUnlock trial analytics

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 to 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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Frequently asked questions about Liquid CAIV-T

What is Liquid CAIV-T used for?

Liquid CAIV-T is an investigational small molecule being developed for influenza. It is a trivalent, live, cold adapted influenza vaccine studied in children 6 to 59 months of age. The drug is currently in Phase 3 clinical development and remains investigational, not yet approved by regulatory authorities.

Who makes Liquid CAIV-T?

Liquid CAIV-T is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical research on this influenza vaccine candidate in the infectious disease therapeutic area.

What phase is Liquid CAIV-T in?

Liquid CAIV-T is in Phase 3 clinical development for influenza. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy in the target patient population.

What clinical trials is Liquid CAIV-T in?

Liquid CAIV-T has one completed Phase 3 clinical trial registered as NCT00128167. This study, titled 'Trivalent, Live, Cold Adapted Influenza Vaccine (CAIV-T) Against Inactivated Influenza Vaccine (TIV) in Children 6-59 Months of Age,' enrolled 8,500 participants across multiple countries including the United States, Belgium, Czechia, Hong Kong, Ireland, South Korea, Taiwan, and the United Kingdom.

Is Liquid CAIV-T the same as CAIV-T?

Liquid CAIV-T is a formulation of the trivalent, live, cold adapted influenza vaccine, commonly referred to as CAIV-T. The clinical trial NCT00128167 uses both names to describe the investigational vaccine being studied in children aged 6 to 59 months for the prevention of influenza.