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Cold-adapted influenza vaccine trivalent · 2 trials · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Cold-adapted influenza vaccine trivalent (CAIV-T) | EXPERIMENTAL | A single 0.2 mL dose of 10\^7 fluorescent focus units was administered intranasally. |
| Trivalent Inactivated Vaccine (TIV) | ACTIVE_COMPARATOR | A single dose was administered by intramuscular injection. |
| CAIV-T | EXPERIMENTAL | The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril). |
| Placebo | PLACEBO_COMPARATOR | The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril). |
| Name | Type | Description |
|---|---|---|
| Cold-adapted influenza vaccine trivalent (CAIV-T) | BIOLOGICAL | Liquid 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) | BIOLOGICAL | Commercially 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). |
| Placebo | BIOLOGICAL | The placebo consisted of physiologic normal saline. |
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;...
Cold-adapted influenza vaccine trivalent is an investigational vaccine being studied for the prevention of influenza. It is a trivalent formulation designed to protect against three strains of the influenza virus. The vaccine is currently in clinical development and has not been approved by regulatory authorities.
Cold-adapted influenza vaccine trivalent 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 the vaccine's safety, tolerability, and efficacy in different age groups.
Cold-adapted influenza vaccine trivalent is in Phase 3 clinical development. It has completed two clinical trials, including a Phase 2 study and a Phase 3 study. The vaccine remains investigational and is not yet approved for public use.
Cold-adapted influenza vaccine trivalent has completed two clinical trials. NCT00192179 was a Phase 2 trial assessing safety and tolerability in healthy children and adolescents aged 6 to less than 18 years. NCT00192413 was a Phase 3 trial comparing the vaccine with an inactivated influenza vaccine in adults aged 60 years and older.
Yes, Cold-adapted influenza vaccine trivalent is also known as CAIV-T, which stands for Cold-adapted Influenza Vaccine Trivalent. The clinical trials for this vaccine use the CAIV-T designation, and it is being studied for the prevention of influenza in various populations.