Skip to main content

Advertisement

Table 5 Safety of influenza vaccination during the 14 days following administration, by randomization group

From: A randomized, placebo-controlled, double-blinded, single-centre, phase IV trial to assess the efficacy and safety of OM-85 in children suffering from recurrent respiratory tract infections

Characteristic Treatment, 3 months (n = 44) Placebo (n = 43) Treatment, 6 months (n = 15)
n % n % n %
Local adverse events 3 6.8 3 6.9 1 6.7
Erythema 3 6.8 2 4.7 1 6.7
Swelling/induration 1 2.3 1 2.3 1 6.7
Systemic adverse events 4 9.0 4 9.3 2 13.3
Fever ≥ 38 °C 3 6.8 2 4.7 1 6.7
Irritability 4 9.0 3 6.9 1 6.7
Lack of appetite 3 6.8 2 4.7 1 6.7
Vomiting 1 2.3 0 0 0 0
At least one local or systemic adverse event 6 13.6 7 16.3 3 20.0
Required drugs for adverse events 3 6.8 4 9.3 1 6.7
Severe adverse events 0 0 0 0 0 0