<p>The safety profile is described below according to the clinical data generated in France, South Korea, Chile and Thailand. In clinical studies in children who received TETRAXIM as a primary series, stand alone or combined with the Act- HIB vaccine, the most frequently reported reactions are local injection-site reactions, abnormal crying, loss of appetite and irritability. These signs and symptoms usually occur within 48 hours following the vaccination and may continue for 48-72 hours. They resolve spontaneously without requiring specific treatment. The frequency of injection-site reactions tends to increase at booster vaccination compared with the frequency observed for primary series. The safety profile of TETRAXIM does not differ significantly according to age groups. However certain reactions (myalgia, malaise, headache) are specific to children aged 2 years or more.</p>