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CAIV-T or TIV

Phase 3

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

CAIV-T or TIV development status

Highest phase Phase 3
Registered trials 2 across 1 sponsor since Sep 2005

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials2
Total Enrollment2,440

FDA Designations

No designations recorded

CAIV-T or TIV clinical trials

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 InfectionsUnlock trial analytics

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 influenza virus vaccine being studied for the prevention of influenza and respiratory tract infections. It is a monoclonal antibody modality being developed by AstraZeneca PLC. The vaccine has been evaluated in clinical trials involving healthy adults and children.

Who makes CAIV-T or TIV?

CAIV-T or TIV is being developed by AstraZeneca PLC, which is publicly traded under the ticker AZN. The company is conducting clinical trials to evaluate the vaccine's safety and immune responses in different populations, including healthy adults and children.

What phase is CAIV-T or TIV in?

CAIV-T or TIV is in Phase 2 clinical development. While one Phase 2 trial has been completed, the vaccine is still investigational and has not been approved by regulatory authorities. It remains in clinical development for influenza and respiratory tract infections.

What clinical trials is CAIV-T or TIV in?

CAIV-T or TIV has been studied in clinical trials including NCT00192153, a Phase 2 trial in healthy adults aged 18 and older, and NCT00192205, a Phase 3 trial in children. Both trials are completed, with the Phase 3 trial 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 vaccine, while TIV is a trivalent inactivated vaccine. They were studied together to compare safety, tolerability, and efficacy in children.