Efficacy of a Pneumococcal Conjugate Vaccine Against Acute Otitis Media
This study, published in the New England Journal of Medicine, enrolled 1662 infants in a randomized, double-blind efficacy trial of a heptavalent pneumococcal polysaccharide conjugate vaccine in which the carrier protein is the nontoxic diphtheria-toxin analogue CRM197. The children received either the study vaccine or a hepatitis B vaccine as a control at 2, 4, 6, and 12 months of age. The clinical diagnosis of acute otitis media was based on predefined criteria, and the bacteriologic diagnosis was based on a culture of middle-ear fluid obtained by myringotomy.
Author(s): Eskola J, Kilpi T, Palmu A, et al.
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Citation: Eskola J, Kilpi T, Palmu A, et al. Efficacy of a Pneumococcal Conjugate Vaccine Against Acute Otitis Media. New England Journal of Medicine. 2001;344(6):403-409.