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CAIV-T or TIV

Phase 3

Respiratory Tract Infections | Monoclonal antibody | Infectious Disease |AstraZeneca PLC|Last Updated: Sep 13, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment2,200

FDA Designations

No designations recorded

Clinical trial landscape

CAIV-T or TIV · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT00192205Trial to Compare the Safety,Tolerability and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Influenza Virus Vaccine, Trivalent, Inactivated (TIV) in ChildrenRespiratory Tract Infections
COMPLETED2,200 Analytics
PHASE3COMPLETED
Trial to Compare the Safety,Tolerability and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Influenza Virus Vaccine, Trivalent, Inactivated (TIV) in Children
Respiratory Tract Infections
NCT001922052,200
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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
To perform a variety of immunological assays using blood, serum, nasal washed an cells for application in the further investigation of immune responses generated by influenza virus vaccine, trivalent, types A and B, live, cold-adapted.

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
CAIV-T or TIVBIOLOGICAL -
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Eligibility Criteria

Age Range6 Months to 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:IsraelSpainUnited States
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Frequently asked questions about CAIV-T or TIV

What is CAIV-T or TIV used for?

CAIV-T or TIV is an investigational monoclonal antibody being developed for influenza and respiratory tract infections. It is studied in healthy adults and children to evaluate immune responses and compare safety, tolerability, and efficacy against influenza virus. The drug is in clinical development and has not been approved by regulatory authorities.

Who makes CAIV-T or TIV?

CAIV-T or TIV is developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in preventing or treating influenza and related respiratory infections.

What phase is CAIV-T or TIV in?

CAIV-T or TIV is in Phase 2 clinical development. One Phase 2 trial has been completed, along with a Phase 3 trial, both focusing on influenza and respiratory tract infections. The drug remains investigational and is not yet approved for commercial use.

What clinical trials is CAIV-T or TIV in?

CAIV-T or TIV has been studied in two completed trials. NCT00192153 is a Phase 2 trial in healthy adults aged 18 and older in the United States, enrolling 240 participants. NCT00192205 is a Phase 3 trial in children aged 6 months and older in Israel and Spain, enrolling 2,200 participants.

Is CAIV-T or TIV the same as TIV?

CAIV-T and TIV are two different influenza vaccine formulations compared in clinical trials. CAIV-T is a live attenuated influenza vaccine, while TIV is a trivalent inactivated vaccine. They are studied together to assess differences in safety, tolerability, and efficacy against influenza.