Randomized, controlled trial efficacy of pneumococcal conjugate vaccine against otitis media among Navajo and White Mountain Apache infants.

We report the phase III trial efficacy of 7-valent pneumococcal conjugate vaccine against clinical and culture proven otitis media (OM) among Navajo and White Mountain Apache infants. Efficacy was -0.4% (95% CI: -19.4 to 15.6) for clinically-diagnosed OM, 5.1% (95% CI: -51.5 to 40.6) for severe OM, and 64% (95% CI: -34% to 90%) for vaccine serotype pneumococcal OM suggesting that this vaccine is efficacious for pneumococcal OM in this high risk population.