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CAIV-T, Liquid

Phase 3

Influenza | 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

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials10
Total Enrollment9,986

FDA Designations

No designations recorded

Clinical trial landscape

CAIV-T, Liquid · 10 trials · 1 indication

Phase 3 6Phase 2 4
NCT00192426Trial to Evaluate the Immune Response to OPV When Administered Concomitantly With CAIV-T to Healthy Children.Influenza
COMPLETED2,400 Analytics
NCT00192231Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine,(CAIV-T)Influenza
COMPLETED120 Analytics
NCT00217230Trial To Assess Safety And Efficacy Of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) In Adults Aged 60 Years And OlderInfluenza
COMPLETED3,000 Analytics
NCT00192192Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold Adapted (CAIV-T) in Healthy AdultsInfluenza
COMPLETED20 Analytics
NCT00192283Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold- Adapted (CAIV-T) in Healthy Children Attending Day Care CentersInfluenza
COMPLETED2,903 Analytics
NCT00192361Trial of the Safety, Transmissibility, and Phenotypic and Genotypic Stability of Influenza Virus Vaccine,(CAIV-T), in Children Who Attend Day Care. (Final Report Version 2.0)Influenza
COMPLETED200 Analytics
PHASE3COMPLETED
Trial to Evaluate the Immune Response to OPV When Administered Concomitantly With CAIV-T to Healthy Children.
InfluenzaUnlock trial analytics
PHASE3COMPLETED
Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine,(CAIV-T)
InfluenzaUnlock trial analytics
PHASE3COMPLETED
Trial To Assess Safety And Efficacy Of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) In Adults Aged 60 Years And Older
InfluenzaUnlock trial analytics
PHASE3COMPLETED
Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold Adapted (CAIV-T) in Healthy Adults
InfluenzaUnlock trial analytics
PHASE3COMPLETED
Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold- Adapted (CAIV-T) in Healthy Children Attending Day Care Centers
InfluenzaUnlock trial analytics
PHASE3COMPLETED
Trial of the Safety, Transmissibility, and Phenotypic and Genotypic Stability of Influenza Virus Vaccine,(CAIV-T), in Children Who Attend Day Care. (Final Report Version 2.0)
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary immunogenicity endpoint is the proportion of subjects achieving a post-vaccination serum antibody response for each antigen component of OPV and CAIV-T.
The safety objective was to assess the safety and tolerability of CAIV-T vaccine.
The primary study endpoint was the comparison of efficacy of CAIV-T versus placebo against culture-confirmed influenza-illness caused by community-acquired influenza subtypes that were antigenically similar to those contained in the vaccine.
Assays on blood, serum, nasal wash samples and cells obtained from healthy adult subjects
The primary endpoint for efficacy is the first episode in a study child of a cultureconfirmed influenza illness.
28 days after vaccination
The primary endpoint of the study was the determination of the proportion of placebo recipients from whom any of the vaccine strains were isolated.
The following immunogenicity endpoints: The strain-specific HAI seroconversion rates (≥ 4-fold increase) among baseline seronegative participants (HAI titer ≤ 1:4), by dose number
Day 28 post final vaccination
The proportion of participants achieving ≥ 4-fold increase in strain-specific HAI titer from baseline in all participants regardless of baseline serostatus, by dose number
Day 28 post final vaccination
All episodes of AOM, occurring during the influenza season, associated with a positive culture for influenza virus antigenically similar to those contained in the vaccine.
Kinetics of the hemagglutination inhibition antibody response to each vaccine strain
Day 0-28

The geometric mean titers for each strain between Day 0 and 28 were examined.

Measurement of influenza-specific immune response following receipt of CAIV-T.

Secondary Endpoints

The secondary endpoint for immunogenicity is the geometric mean titer (GMT) of serum antibody for each antigen component of OPV or the geometric mean ratio relative to the baseline titer of CAIV-T serum antibody components.
A secondary comparison of interest was the incidence of culture-confirmed influenza-illness caused by any antigenic subtype.
The secondary endpoint for culture-confirmed influenza illness is the first episode caused by any community-acquired antigenic subtype which occurs following receipt of the second dose of study vaccine or placebo.
28 days after vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTALCAIV-T
2PLACEBO_COMPARATORPlacebo
Cold-adapted influenza vaccine (CAIVT)EXPERIMENTALA single intranasal dose of 10\^7 fluorescent focus units.
Trivalent inactivated vaccine (TIV)ACTIVE_COMPARATORA single dose of commercially available Flushield was administered intramuscularly.
PlaceboPLACEBO_COMPARATORThe 0.2 mL administered intranasally.

Interventions

NameTypeDescription
CAIV-TBIOLOGICAL -
PlaceboOTHERA single dose of placebo volume of 0.2 mL was administered intranasally with the spray applicator intended for commercial use (approximately 0.1 mL into each nostril).
TIVOTHERA total vol. of 0.25 will be administered intramuscularly for each of two doeses.
CAIV-T, LiquidBIOLOGICAL -
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Eligibility Criteria

Age Range6 Months to 36 Months
SexALL
Healthy VolunteersYes

Inclusion Criteria: * who are aged at least 6 months and less than 36 months of age at the time of first vaccination * who have received a full primary vaccination schedule consisting of three doses of OPV in the first year of life * who are in good health as determined by medical history, physical...

Countries:AustraliaSouth AfricaUnited StatesFinlandSingapore
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Frequently asked questions about CAIV-T, Liquid

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.