Efficacy of pneumococcal conjugate vaccine against PCR-positive acute otitis media.

We aimed to assess the efficacy of a pneumococcal conjugate vaccine against acute otitis media (AOM) positive by pneumolysin-PCR (Ply-PCR). 1662 infants vaccinated with PncCRM or control vaccine using random allocation were followed for AOM up to 24 months of age. When AOM was diagnosed a middle ear fluid sample was obtained for etiological assays. During the per protocol follow-up period the PncCRM vaccine efficacy was 19% against Ply-PCR-positive AOM but only 3% when culture-positive cases were excluded. The data do not support effect of PncCRM on AOM in which only Ply-PCR suggests pneumococcal etiology.