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Pharmacology: Pharmacodynamics: Mechanism of action: INFLUVAC Tetra provides active immunisation against four influenza virus strains: an A/(H1N1) strain, an A/(H3N2) strain, and two B strains (one from each lineage; B/(Victoria) and B/(Yamagata)). INFLUVAC Tetra manufactured according to the same process as the trivalent influenza vaccine Influvac, induces humoral antibodies against the haemagglutinins. These antibodies neutralise influenza viruses.
Specific levels of hemagglutination-inhibition (HI) antibody titer post-vaccination with inactivated influenza virus vaccines have not been correlated with protection from influenza illness but the HI antibody titers have been used as a measure of vaccine activity.
An immune response is generally obtained within 2 to 3 weeks. The duration of postvaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually 6-12 months.
Pharmacodynamic effects: Immunogenicity of INFLUVAC Tetra compared to trivalent influenza vaccine Influvac: Clinical studies performed in adults of 18 years of age and older (INFQ3001) and children of 3 to 17 years of age (INFQ3002) assessed the safety and immunogenicity of INFLUVAC Tetra and its non-inferiority to trivalent influenza vaccine Influvac for the postvaccination HI Geometric mean antibody titer (GMT).
In both studies the immune response elicited by INFLUVAC Tetra against the three strains in common was non-inferior to trivalent influenza vaccine Influvac. INFLUVAC Tetra elicited a superior immune response against the additional B strain included in INFLUVAC Tetra compared to trivalent influenza vaccine Influvac.
18 years of age and older: In clinical study INFQ3001, 1,535 adults of 18 years of age and older received a single dose of INFLUVAC Tetra and 442 subjects received a single dose of trivalent Influvac: See Table 1.
Click on icon to see table/diagram/imagePaediatric population: Children 3-17 years of age: In clinical study INFQ3002, 402 children of 3 to 17 years of age received one or two doses of INFLUVAC Tetra and 798 children received one or two doses of trivalent Influvac based on their influenza vaccination history. (See Table 2.)
Click on icon to see table/diagram/imagePharmacokinetics: Not applicable.
Toxicology: Preclinical Safety Data: Non-clinical data revealed no special hazard for humans based on conventional studies of repeat dose and local toxicity, reproductive and developmental toxicity and safety pharmacology studies
