TetraFlu Mechanism of Action

Pharmacotherapeutic group: Influenza vaccine. ATC code: J07BB02.
Pharmacology: Pharmacodynamics: Seroprotection is generally obtained within 3 weeks. The duration of postvaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies.
Clinical Studies: In a clinical study that evaluated the immunogenicity of single injection of TetraFlu or the licensed trivalent flu vaccine in healthy subjects aged over or equal to 18 years the H1 antibody response is shown as follows. (See Tables 1 and 2.)

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Immune responses to each antigen of TetraFlu 21 days after vaccination in adults: See Tables 3 and 4.

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Immune responses to each antigen of TetraFlu at four weeks after the last vaccination in children: See Table 5.

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CHMP criteria: At least one of the previously mentioned serological assessments should meet the indicated requirements for assessment of seasonal flu vaccines.
Incidence of Solicited Local and Systemic Adverse Events within 7 Days of Vaccination: See Table 6.

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Pharmacokinetics: Not applicable.
Toxicology: Preclinical Safety Data: A comparative toxicity study was conducted to compare the toxicity of AdimFlu trivalent influenza vaccine and TetraFlu influenza vaccine, at doses of 0.5 mL/animal, given by intramuscular injection to NZW rabbits three times at 2 weeks interval. All animals survived at the end of the study. There were no adverse effects observed in clinical observations, body weights, food consumption, ophthalmology, clinical pathology, gross necropsy and major organ histopathology.