Abstract
14-valent pneumococcal or a control H. influenzae type b vaccine were randomly given to 827 children after one or more attacks of acute otitis media. Adverse reactions to the vaccines, although common, were mild and transient. ≥ 13 days but ≤ 6 months after vaccination clinically acute recurrences of otitis media due to vaccine-type pneumococci (group 6 excluded) were significantly (p ≤ .001) fewer in children ⩾ 9 months at the time of vaccination than in the control group; younger children were not protected by the vaccine. The protection against specific pneumococcal types or groups correlated with serum antibody responses; consistently there was no protection against group 6 pneumococci. Acute attacks with non-vaccine types or groups of pneumococci, H. influenzae or with other bacteria only were equally distributed in the vaccine groups; those without culturable bacteria were slightly more frequent among the children who got the pneumococcal vaccination. The total reduction of acute attacks with effusion was 10–15 %, and of almost the same magnitude if also non-acute visits with effusion were included.