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 reported 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.