VaxigripTetra Adverse Reactions

Summary of the safety profile: The safety of VaxigripTetra was assessed in six clinical trials in which 3,040 adults from 18 to 60 years of age, 1,392 elderly over 60 years of age and 429 children from 9 to 17 years of age received one dose of VaxigripTetra 884 children from 3 to 8 years of age received one or two doses of VaxigripTetra depending on their influenza vaccination history and 1,614 children from 6 to 35 months of age received two doses (0.5 mL) of VaxigripTetra.
Most reactions usually occurred within the first 3 days following vaccination, resolved spontaneously within 1 to 3 days after onset. The intensity of these reactions was mild.
The most frequently reported adverse reaction after vaccination, in all populations, including the whole group of children from 6 to 35 months of age, was injection site pain (between 52.8% and 56.5% in children from 3 to 17 years of age and in adults, 26.8% in children from 6 to 35 months of age and 25.8% in elderly). In subpopulation of children less than 24 months of age, irritability (32.3%) was the most frequently reported adverse reaction.
In subpopulation children from 24 to 35 months of age, malaise (26.8%) is the most frequently reported adverse reaction.
The other most frequently reported adverse reactions after vaccination were: In adults: headache (27.8%), myalgia (23%) and malaise (19.2%); In elderly: headache (15.6%) and myalgia (13.9%); In children from 9 to 17 years of age: myalgia (29.1%), headache (24.7%), malaise (20.3%) and injection site swelling (10.7%); In children from 3 to 8 years of age: malaise (30.7%), myalgia (28.5%), headache (25.7%), injection site swelling (20.5%), injection site erythema (20.4%), injection site induration (16.4%), shivering (11.2%); For all children from 6 to 35 months of age: fever (20.4%) and injection site erythema (17.2%); In children less than 24 months of age: appetite lost (28.9%), crying abnormal (27.1%), vomiting (16.1%) and drowsiness (13.9%); In children from 24 months to 35 months of age: headache (11.9%) and myalgia (11.6%).
Adverse reactions were generally less frequent in the elderly than in adults and children.
Tabulated summary of adverse reactions: The data as follows summarize the frequencies of the adverse reactions that were recorded following vaccination with VaxigripTetra during clinical trials and worldwide post-marketing surveillance.
Adverse events are ranked under headings of frequency using the following convention: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000).
Not known (cannot be estimated from available data): adverse reactions have been spontaneously reported following commercial use of VaxigripTetra.
Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency.
Within each frequency grouping, the adverse reactions are presented in decreasing order of seriousness.
Adults and elderly: The safety profile presented as follows is based on: data from 3,040 adults from 18 to 60 years of age and 1,392 elderly over 60 years of age; data from worldwide post-marketing surveillance (*). (See Table 8.)

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Paediatric population: The safety profile presented as follows is based: on data from 429 children from 9 to 17 years of age who received one dose of VaxigripTetra and from 884 children from 3 to 8 years of age who received one or two doses of VaxigripTetra depending on their influenza vaccination history; data from worldwide post-marketing surveillance (*). (See Table 9.)

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The safety profile presented as follows is based on: data from 1,614 children from 6 to 35 months of age who received two doses of VaxigripTetra; data from worldwide post-marketing surveillance (*). (See Table 10.)

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In children from 6 months to 8 years of age, the safety profile of VaxigripTetra was similar after the first and the second injections with a trend of lower incidence of adverse reactions after the second injection compared to the first one in children from 6 to 35 months of age.
Adverse events: The following adverse events were reported following commercial use of Vaxigrip. A causal relationship with VaxigripTetra has not been established.
Blood and lymphatic system disorders: Transient thrombocytopenia⁽¹⁾, lymphadenopathy⁽¹⁾.
Nervous system disorders: Paraesthesia⁽¹⁾, Guillain-Barré Syndrome (GBS), neuritis, neuralgia, convulsions, encephalomyelitis.
Vascular disorders: Vasculitis, such as Henoch-Schönlein purpura, with transient renal involvement in certain cases.
⁽¹⁾ These adverse events were reported during clinical trials only in some age groups (see Tabulated summary of adverse reactions as previously mentioned).
Other special population: The safety profile of VaxigripTetra observed in a limited number of subjects with co-morbidities enrolled in the clinical studies does not differ from the one observed in the overall population. In addition, studies conducted with Vaxigrip in renal transplant patients, and asthmatic patients showed no major differences in terms of safety profile of Vaxigrip in these populations.
Pregnant women: In clinical studies conducted in pregnant women in South Africa and Mali with Vaxigrip (see Use in Pregnancy & Lactation and Pharmacology: Pharmacodynamics under Actions), the frequencies of local and systemic solicited reactions reported within 7 days following administration of the vaccine were consistent with those reported for the adult population during clinical studies conducted with Vaxigrip. In the South Africa study, local reactions were more frequent in the Vaxigrip group than in the placebo group in both HIV-negative and HIV-positive cohorts. There were no other significant differences in solicited reactions between Vaxigrip and placebo groups in both cohorts.
In one clinical study conducted in pregnant women in Finland with VaxigripTetra (see Use in Pregnancy & Lactation and Pharmacology: Pharmacodynamics under Actions), frequencies of local and systemic solicited reactions reported within 7 days following administration of VaxigripTetra were consistent with those reported for the adult population (with the exception of pregnant women) during clinical studies conducted with VaxigripTetra even though higher for some adverse reactions (injection site pain, malaise, shivering, headache, myalgia).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation 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 via the national reporting system.