ABSTRACT
Prevention of acute otitis media (AOM) by BPIG was tested in a randomized, stratified, double-blind, placebo-controlled protocol (21). Children ~24 months of age with one to three prior episodes of AOM received BIPG (0.5 mllkg) or saline placebo at entry and 30 days later. Although the incidence of AOM due to all organisms during the 120-day study period was similar for both BPIG and placebo recipients, pneumococcal AOM was significantly less frequent in BPIG recipients (0.21 episodes per patient) than in placebo (0.45 episodes per patient, P = .05). At the time of this writing, BPIG has not been approved for licensure by regulatory agencies.
