Tme. Govaert et al., ADVERSE REACTIONS TO INFLUENZA VACCINE IN ELDERLY PEOPLE - RANDOMIZEDDOUBLE-BLIND PLACEBO-CONTROLLED TRIAL, BMJ. British medical journal, 307(6910), 1993, pp. 988-990
Objective-To assess the frequency and type of side effects after influ
enza vaccination in elderly people. Design-Randomised double blind pla
cebo controlled study. Setting-15 general practices in the southern Ne
therlands. Subjects-1806 patients aged 60 or older, of whom 904 receiv
ed influenza vaccine and 902 placebo. Main outcome measures-Adverse re
actions reported on postal questionnaire completed four weeks after va
ccination. Results-210 (23%) patients given vaccine reported one or mo
re adverse reactions compared with 127 (14%) given placebo. The freque
ncy 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 systemi
c adverse reactions (11% v 9.4%; p=0.34). In general, men reported few
er side effects than women. Conclusion-Only local side effects were mo
re common in vaccinated patients and all side effects were mild.