ADVERSE REACTIONS TO INFLUENZA VACCINE IN ELDERLY PEOPLE - RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL

Objective-To assess the frequency and type of side effects after influenza vaccination in elderly people. Design-Randomised double blind placebo controlled study. Setting-15 general practices in the southern Netherlands. Subjects-1806 patients aged 60 or older, of whom 904 received influenza vaccine and 902 placebo. Main outcome measures-Adverse reactions reported on postal questionnaire completed four weeks after vaccination. Results-210 (23%) patients given vaccine reported one or more adverse reactions compared with 127 (14%) given placebo. The frequency of local adverse reactions were 17.5% in the vaccine group and 7.3% in the placebo group (p < 0.001). There was no difference in systemic adverse reactions (11% v 9.4%; p=0.34). In general, men reported fewer side effects than women. Conclusion-Only local side effects were more common in vaccinated patients and all side effects were mild.