Influvac Tetra Adverse Reactions

Summary of the safety profile: The safety of Influvac Tetra was assessed in three clinical trials. In two clinical trials, 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. In a third study, the safety of Influvac Tetra was assessed in healthy children from 6 months to 35 months of age administered Influvac Tetra or a non-influenza vaccine control. In both children studies, children from 6 months 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 (11.2%) and headache for children from 3 - 5 years of age drowsiness, irritability and loss of appetite.
The most frequently reported general adverse reactions after vaccination observed in the clinical studies for Influvac Tetra in children from 6 months to 35 months of age were irritability/fussiness. Similar rates of solicited adverse reactions were observed in recipients of Influvac Tetra and trivalent influenza vaccine Influvac.
The rates of solicited systemic adverse reactions were similar in recipients of Influvac Tetra and the non-influenza vaccine, whereby the rate of solicited local adverse reactions were lower in recipients of Influvac Tetra.
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 Influvac Tetra and/or 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).
Adults and elderly: (See Table 5.)

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Paediatric population: (See Table 6.)

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Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.