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Cold-adapted influenza vaccine trivalent

Phase 3

Influenza | Vaccine | Infectious Disease |AstraZeneca PLC|Trials Updated: Mar 14, 2012

Cold-adapted influenza vaccine trivalent target and mechanism

ModalityVaccine

Also known as Cold-adapted influenza vaccine trivalent (CAIV-T)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment3,249

FDA Designations

No designations recorded

Cold-adapted influenza vaccine trivalent clinical trials

Cold-adapted influenza vaccine trivalent · 2 trials · 1 indication

Phase 3 1Phase 2 1
NCT00192413Trial to Compare the Safety, Tolerability, and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Inactivated, Influenza Vaccine, Trivalent, Types A & B, in Adults Aged 60 Years and Older Against Culture-confirmed InfluenzaInfluenza
COMPLETED3,009 Analytics
PHASE3COMPLETED
Trial to Compare the Safety, Tolerability, and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Inactivated, Influenza Vaccine, Trivalent, Types A & B, in Adults Aged 60 Years and Older Against Culture-confirmed Influenza
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

The first episode of a culture-confirmed influenza-illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine, which occurs at least 15 days following receipt of a dose of study vaccine.
Dosing through 30Nov2002

The criteria for obtaining nasal and throat swabs for viral culture were any one of the following: A feeling of "feverishness", An oral temperature ≥37.2ºC, Sore throat, New or increased cough, Malaise, Myalgia. Swabs for viral cultures were also obtained, if, in the opinion of the investigator, the symptom complex so warranted.

Number of subjects with fever greater than or equal to 39.1C oral
Days 0-7

Secondary Endpoints

The first episode of a culture-confirmed influenza-illness, caused by any community-acquired subtype, which occurs at least 15 days following receipt of a dose of study vaccine.
15 days after dosing through 30Nov2002
The first episode in a study subject of a culture-confirmed influenza illness caused by community-acquired virus of each of the subtypes antigenically similar to those contained in the vaccine
15 days after dosing through 30Nov2002
The first episode in a study subject of a culture-confirmed influenza illness caused by any community-acquired virus of each of the subtypes.
15 days after dosing through 30Nov2002
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Cold-adapted influenza vaccine trivalent (CAIV-T)EXPERIMENTALA single 0.2 mL dose of 10\^7 fluorescent focus units was administered intranasally.
Trivalent Inactivated Vaccine (TIV)ACTIVE_COMPARATORA single dose was administered by intramuscular injection.
CAIV-TEXPERIMENTALThe total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).
PlaceboPLACEBO_COMPARATORThe total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).

Interventions

NameTypeDescription
Cold-adapted influenza vaccine trivalent (CAIV-T)BIOLOGICALLiquid CAIV-T vaccine for this study consisted of 3 cold-adapted, attenuated, reassortant strains, representing the HA and NA antigens of the A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2), and B/Victoria/504/2000 influenza strains. The vaccine contained no preservatives and had a pH of 7.2 ± 0.5.
Trivalent Inactivated Vaccine (TIV)BIOLOGICALCommercially available TIV, inactivated influenza vaccine (Split Virion) BP (Aventis Pasteur MSD, Lyon, France) was administered IM according to the manufacturer's dosing instructions (one 0.5-mL IM dose for adults).
PlaceboBIOLOGICALThe placebo consisted of physiologic normal saline.
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Eligibility Criteria

Age Range60 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * who are aged at least 60 years or older at the time of enrollment; * who are determined by medical history, physical examination and clinical judgement to be eligible for this study; * who have provided written informed consent after the nature of the study has been explained;...

Countries:South AfricaBelgiumPolandUnited Kingdom
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Frequently asked questions about Cold-adapted influenza vaccine trivalent

What is cold-adapted influenza vaccine trivalent used for?

Cold-adapted influenza vaccine trivalent is a vaccine being developed for the prevention of influenza. It is designed to protect against influenza virus types A and B. The vaccine has been studied in adults aged 60 years and older and in healthy children and adolescents aged 6 to less than 18 years.

Who is developing cold-adapted influenza vaccine trivalent?

Cold-adapted influenza vaccine trivalent is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the company responsible for the clinical development of this influenza vaccine candidate.

What phase is cold-adapted influenza vaccine trivalent in?

Cold-adapted influenza vaccine trivalent is in Phase 3 clinical development. A Phase 3 trial has been completed, and a Phase 2 trial has also been completed. The vaccine remains an investigational product and has not been approved by the FDA.

What clinical trials is cold-adapted influenza vaccine trivalent in?

Cold-adapted influenza vaccine trivalent has been evaluated in two completed clinical trials. NCT00192413 was a Phase 3 trial in adults aged 60 years and older in South Africa, enrolling 3,009 participants. NCT00192179 was a Phase 2 trial in healthy children and adolescents aged 6 to less than 18 years in Belgium, Poland, and the United Kingdom, enrolling 240 participants.

Is cold-adapted influenza vaccine trivalent the same as CAIV-T?

Yes, cold-adapted influenza vaccine trivalent is also known as CAIV-T. CAIV-T is the abbreviated name for this influenza vaccine candidate. Both names refer to the same investigational vaccine developed by AstraZeneca PLC for the prevention of influenza.