title: Review of randomized controlled trials on pneumococcal vaccination for prevention of otitis media.
abstract: BACKGROUND
  Increasing resistance to antibiotics of the pathogens causing acute otitis media (AOM) emphasize the need for effective methods to prevent episodes of otitis media in young children.
  
  
  OBJECTIVE
  To assess the effectiveness of pneumococcal vaccination for prevention of AOM in children age 12 years and younger.
  
  
  METHODS
  Systematic review of 11 randomized controlled trials including 46 074 children in whom pneumococcal vaccination against AOM was compared with a control treatment. Vaccine effect was estimated as a rate ratio (RR): AOM episodes per child month in pneumococcal vaccination group divided by the AOM episodes per child-month in control group.
  
  
  RESULTS
  A moderate effect of pneumococcal polysaccharide vaccination was found in children 24 months of age and older [RR 0.78; 95% confidence interval (CI) 0.63 to 0.97]. Pneumococcal polysaccharide vaccine had little effect on prevention of AOM in children without previous documented episodes before vaccination (RR 0.92; 95% CI 0.85 to 0.99). Better efficacy was seen in those children with documented prior AOM before vaccination (RR 0.81; 95% CI 0.72 to 0.91). Pooled results of pneumococcal conjugate vaccine trials in infants vaccinated as early as 2 months of age and in toddlers attending day care showed only a small effect on prevention of AOM (RR 0.92; 95% CI 0.85 to 0.99).
  
  
  CONCLUSIONS
  Based on these results, a large scale pneumococcal vaccination program for a primary indication of preventing AOM in infancy is not indicated. The results of ongoing trials should provide more information whether the conjugate vaccine is effective in high risk (otitis-prone) children after 1 year of age.
authors.affiliation: Department of Epidemiology and Biostatistics, University Medical Center Nijmegen, Nijmegen, the Netherlands.
authors.forename: Masja
authors.initials: M
authors.lastname: Straetemans
authors.forename: Elisabeth A
authors.initials: EA
authors.lastname: Sanders
authors.forename: Reinier H
authors.initials: RH
authors.lastname: Veenhoven
authors.forename: Anne G
authors.initials: AG
authors.lastname: Schilder
authors.forename: Roger A
authors.initials: RA
authors.lastname: Damoiseaux
authors.forename: Gerhard A
authors.initials: GA
authors.lastname: Zielhuis
mesh_terms: D000208:Acute Disease; D002648:Child; D002675:Child, Preschool; D003140:Communicable Disease Control / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D017589:Immunization Programs; D007223:Infant; D008297:Male; D010033:Otitis Media / Q000382:microbiology / Q000517:prevention & control*; D011008:Pneumococcal Infections / Q000517:prevention & control*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage*; D016012:Poisson Distribution; D011336:Probability; D015397:Program Evaluation; D016032:Randomized Controlled Trials as Topic; D014611:Vaccination / Q000379:methods
chemical_list: D022242:Pneumococcal Vaccines