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CAIV-T · 7 trials · 2 indications
Immunogenicity was evaluated by comparison of pre and post-vaccination strain-specific titers of serum HAI antibody. Seroconversion was defined as a four-fold or greater rise in serum HAI antibody titer.
Influenza-like symptoms, ie, typical clinical symptoms of influenza infection, including fever (oral temperature \> or = 38 degrees C), cough, runny or stuffy nose, sore throat, headache, chills, muscular pain, vomiting, decline in activity, decline in appetite.
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | CAIVT-The total volume of 0.2 mL will be administered intranasally with a spray applicator (approximately 0.1 mL into each nostril). |
| 2 | ACTIVE_COMPARATOR | FluMist- The total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). |
| Cold-adapted influenza vaccine trivalent (CAIV-T) | EXPERIMENTAL | All subjects were scheduled to receive 2 doses of CAIV-T.The total volume of 0.2 mL was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril). |
| CAIV-T | ACTIVE_COMPARATOR | CAIV-T contains 3 cold-adapted influenza virus strains (A/H1N1, A/H3N2, B) concentrated and refined by centrifugal separation from the chorioallantoic membrane of specific pathogen-free (SPF) eggs, containing SPG (sucrose-phosphate-glutamate), arginine, and acid hydrolyzed pig gelatin as stabilizers. Subjects were inoculated once with about 0.1 mL of investigational vaccine in each nasal cavity (a total of 0.2 mL) using a nebulizer. |
| Placebo | PLACEBO_COMPARATOR | Placebo contained 0.01 mol/L potassium phosphate buffer containing 0.85% sodium chloride (pH 7.2). Subjects received about 0.1 mL (a total 0.2 mL) of the control drug using a nebulizer. |
| Name | Type | Description |
|---|---|---|
| CAIV-T | BIOLOGICAL | - |
| CAIVT | BIOLOGICAL | The total volume of 0.2 mL will be administered intranasally with a spray applicator (approximately 0.1 mL into each nostril). |
| FluMist | BIOLOGICAL | The total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). |
| CAIV-T, Liquid | BIOLOGICAL | - |
| Placebo | BIOLOGICAL | 0.2 mL of 0.01 mol/L potassium phosphate buffer containing 0.85% sodium chloride (pH 7.2). |
Inclusion Criteria: * Age 5 through 49 years (not yet reached their 50th birthday); * In general good health; * Individual or parent/guardian available by telephone; * Ability of the participant or parent/guardian to understand and comply with the requirements of the protocol; and * Written informe...
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.
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.
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.
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.
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.
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.