Safety of an influenza-split-vaccine in children.

Background: The aim of this study was to investigate the safety of the split-product influenza vaccine Begrivac((R)), containing the recommended virus strains for the influenza season 1998/99. Patients: Eighty-three children aged 6 months-12 years were enrolled in the study. Methods: Adverse events (AEs) were repotted for up to 21 days after the last immunization. A hemagglutination assay was performed of blood samples taken before and after vaccination. Results: Only mild (40%) to moderate and mainly local reactions (redness, swelling, induration and pain) were reported. Seroprotection after the first immunisation was reached against influenza strain A (H1N1) in 75% of the vaccinees, against strain A (H3N2) in 83% and against strain B in 33%. After the second immunisation, 96% of the population achieved seroprotection against A (H1N1), 100% against A (H3N2) and 96% against B. Conclusions: The influenza split vaccine is safe and effective in children.