Vaccination Against Streptococcus pneumoniae in Childhood: Lack of Demonstrable Benefit in Young Australian Children

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Abstract
A double-blind, randomized, controlled trial of a 14-valent S. pneumoniae polysaccharide vaccine, with saline as placebo, was performed on 1273 healthy children 6-54 mo. of age. Different dosage regimens were used for children younger and older than 2 yr of age. The vaccine was well tolerated. Follow-up continued for 2 yr, during which time 95% of mothers submitted diaries of their children''s respiratory tract and otic symptoms. Data from diaries and medical and hospital case notes failed to reveal consistent or significant benefits in those who received the vaccine. In the first 16 mo. after immunization, recipients of placebo experienced an average of 0.69 episodes of otitis media per child, compared with 0.63 in recipients of vaccine (P = 0.6). Recipients of vaccine had no consistent reduction in days of respiratory morbidity, antibiotic consumption, hospitalization or visits to a physician when compared with recipients of placebo.