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CAIV-T and TIV

Phase 3

Asthma | Monoclonal antibody | Respiratory |AstraZeneca PLC|Last Updated: Oct 3, 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment2,229

FDA Designations

No designations recorded

Clinical trial landscape

CAIV-T and TIV · 1 trial · 1 indication

Phase 3 1
NCT00192257Trial to Compare the Safety, Tolerability and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Influenza Virus in Children With AsthmaAsthma
COMPLETED2,229 Analytics
PHASE3COMPLETED
Trial to Compare the Safety, Tolerability and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Influenza Virus in Children With Asthma
Asthma
NCT001922572,229
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Study Endpoints

Primary Endpoints

To demostrate that the efficacy over one influenza season against culture-confirmed influenza illness caused by community-acquired subtypes antifenically similar to those contained in the vaccine

Secondary Endpoints

To demonstrate that the efficacy over one season of a single dose of CAIV-T was not inferior to that of one dose of TIV against culture-confirmed influenza-illness of any subtype
To compare the efficacy over a defined surveillance period against asthma exacerbations, asthma medication, clinical visits, hospitalizations, days off school (pharma-ecomonic measures) associated with influenza-like illness
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
CAIV-T and TIVBIOLOGICAL -
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Eligibility Criteria

Age Range6 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * who are aged at least 6 years to 17 years of age at the time of enrollment; * with a clinical diagnosis of asthma by one of the following criteria: * An International Classification of Diseases, Ninth revision (ICD-9) code 493 AND ≥one prescription for asthma medication; * OR ...

Countries:Belgium
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Competitive Landscape -Asthma 76 trials

CompanyTickerTrialsLead PhaseDrugs
Teva Pharmaceutical Industries Limited Sponsored ADRTEVA4PHASE3Fp/ABS, ABS
Novartis AG Sponsored ADRNVS5PHASE3QVM149, Salmeterol Xinafoate/ Fluticasone Propionate
GSK plc Sponsored ADRGSK5PHASE3FF/UMEC/VI
Sanofi SA Sponsored ADRSNY7PHASE3Dupilumab
AstraZeneca PLCAZN27PHASE3Benralizumab
Generate Biomedicines, Inc.GENB3PHASE3GB-0895
Eli Lilly and CompanyLLY1PHASE2Brenipatide
Incyte CorporationINCY1PHASE2povorcitinib, ICS-LABA
Pfizer Inc.PFE1PHASE2PF-07275315
Kymera Therapeutics, Inc.KYMR1PHASE2KT-621
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE2ARO-RAGE
Upstream Bio, Inc.UPB1PHASE2Verekitug
Sunshine Biopharma IncorporatedSBFM2PHASE3610
Amgen Inc.AMGN1PHASE1AMG 691
Apogee Therapeutics, Inc.APGE1PHASE1APG777
Celldex Therapeutics, Inc.CLDX1PHASE1CDX-622
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Frequently asked questions about CAIV-T and TIV

What is CAIV-T used for?

CAIV-T is an investigational trivalent cold-adapted influenza vaccine being studied for the prevention of influenza. It has been evaluated in clinical trials involving healthy children, including those as young as 6 months, as well as healthy adults and individuals with asthma.

Who makes CAIV-T?

CAIV-T is being developed by AstraZeneca PLC, which trades under the ticker symbol AZN. The company has sponsored multiple clinical trials of this vaccine candidate across different age groups and countries.

What phase is CAIV-T in?

CAIV-T is in Phase 3 clinical development. It has completed 10 clinical trials with a total enrollment of 9,986 participants. The trials were randomized, double-blind, and active-controlled, and none are currently ongoing.

What clinical trials is CAIV-T in?

CAIV-T has been studied in several completed trials, including NCT00111579, which compared immune responses of CAIV-T with trivalent inactivated vaccine (TIV) in 52 participants, and NCT00192166, which assessed safety and immunogenicity when given with MMR vaccine in 1,200 healthy children aged 11 to 24 months.

Is CAIV-T the same as a flu shot?

CAIV-T is a live attenuated influenza vaccine, not an inactivated flu shot. It is administered intranasally and is designed to induce immune responses similar to natural infection. It has been compared directly with trivalent inactivated vaccine (TIV) in clinical trials.

How does CAIV-T work?

CAIV-T is a cold-adapted live attenuated influenza vaccine. It contains weakened influenza viruses that replicate in the cooler temperatures of the nasal passages, stimulating an immune response without causing full-blown illness. This mechanism is intended to provide protection against influenza.