Influvac Tetra Adverse Reactions

Summary of the safety profile: The safety of INFLUVAC Tetra was assessed in two clinical trials in which healthy adults 18 years of age and older, and healthy children 3 to 17 years of age were administered INFLUVAC Tetra or trivalent influenza vaccine Influvac. Children from 3 to 8 years of age received one or two doses of INFLUVAC Tetra depending on their influenza vaccination history.
Most reactions usually occurred within the first 3 days following vaccination and resolved spontaneously within 1 to 3 days after onset. The intensity of these reactions was generally mild.
In all age groups, the most frequently reported local adverse reaction after vaccination observed in the clinical studies for INFLUVAC Tetra was vaccination site pain.
The most frequently reported general adverse reactions after vaccination observed in the clinical studies for INFLUVAC Tetra in adults and children from 6-17 years of age were fatigue and headache, for children from 3-5 years of age drowsiness, irritability and loss of appetite.
Similar rates of solicited adverse reactions were observed in recipients of INFLUVAC Tetra and trivalent influenza vaccine Influvac.
Tabulated summary of adverse reactions: The following undesirable effects are considered at least possibly related to INFLUVAC Tetra and have either been observed during the clinical trial with INFLUVAC Tetra or are resulting from post-marketing experience with the trivalent influenza vaccine Influvac.
The following frequencies apply: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); and not known (adverse reactions from post-marketing experience; cannot be estimated from the available data).
Adult and elderly: See Table 3.

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Paediatric population: See Table 4.

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