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CAIV-T 10^7

Phase 2

Influenza | Monoclonal antibody | Infectious Disease |AstraZeneca PLC|Last Updated: Feb 17, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment173

FDA Designations

No designations recorded

Clinical trial landscape

CAIV-T 10^7 · 1 trial · 1 indication

Phase 2 1
NCT00192322Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine (CAIV-T) in Healthy ChildrenInfluenza
COMPLETED173 Analytics
PHASE2COMPLETED
Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine (CAIV-T) in Healthy Children
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Measurement of influenza-specific immune response following receipt of CAIV-T.
Day 0 and Day 27

The immune responses were evaluated by hemagglutination inhibition assay (HAI) on serum samples.

Secondary Endpoints

Vaccine virus shedding
Days 2, 6, and 13
Measurement of influenza-specific immune response following receipt of CAIVT.
Day 0 and Day 27
Measurement of influenza-specific immune responses following receipt of CAIVT
Day 0, Day 6, and Day 13
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
CAIV-T 10^5EXPERIMENTALa single intranasal 0.2 mL dose of liquid CAIV-T 10\^5 (approximately 0.1 mL into each nostril)
CAIVT 10^7EXPERIMENTALA single intranasal 0.2 mL dose of liquid CAIV-T 10\^7 (approximately 0.1 mL into each nostril)
PlaceboPLACEBO_COMPARATORA single intranasal 0.2 mL dose of placebo
Trivalent inactivated vaccine (TIV)ACTIVE_COMPARATORA single intramuscular injection of commercially available vaccine

Interventions

NameTypeDescription
CAIV-T 10^7BIOLOGICALa single intranasal 0.2 mL dose of liquid CAIV-T 107 (approximately 0.1 mL into each nostril)
CAIVT 10^5BIOLOGICALa single intranasal 0.2 mL dose of CAIV-T \<10\^5
PlaceboBIOLOGICALa single intranasal 0.2 mL dose of placebo
TIVBIOLOGICALcommercially available TIV injected intramuscularly
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Eligibility Criteria

Age Range6 Months to 36 Months
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * children at least 6 months of age and less than 36 months of age at the time of enrollment, and in good health as determined by medical history, physical examination and clinical judgement; * whose parent/legal guardian has provided written informed consent after the nature of...

Countries:United States
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Frequently asked questions about CAIV-T 10^7

What is CAIV-T 10^7 used for?

CAIV-T 10^7 is an investigational liquid formulation of an influenza virus vaccine being studied for the prevention of influenza. It is being developed by AstraZeneca PLC (AZN) and is currently in Phase 2 clinical development. The vaccine is intended for use in healthy children.

Who makes CAIV-T 10^7?

CAIV-T 10^7 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate this influenza vaccine candidate in pediatric populations.

What phase is CAIV-T 10^7 in?

CAIV-T 10^7 is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the drug remains under evaluation for its safety and immunogenicity.

What clinical trials is CAIV-T 10^7 in?

CAIV-T 10^7 has been studied in one completed Phase 2 clinical trial, registered as NCT00192322. This trial investigated immune responses elicited by a liquid formulation of the influenza virus vaccine in healthy children aged 6 months and older in the United States.

Is CAIV-T 10^7 the same as a flu vaccine?

CAIV-T 10^7 is an investigational liquid formulation of an influenza virus vaccine. It is designed to elicit immune responses against influenza in healthy children. The drug is still in clinical development and has not been approved for public use.