Effect of conjugate pneumococcal vaccine followed by polysaccharide pneumococcal vaccine on recurrent acute otitis media: a randomised study

Lancet. 2003 Jun 28;361(9376):2189-95. doi: 10.1016/S0140-6736(03)13772-5.


Background: Pneumococcal conjugate vaccine prevents recurrent acute otitis media (AOM) in infants immunised at 2, 4, 6, and 12-15 months of age. We aimed to find out whether this vaccine also prevents AOM in older children who have had previous episodes of AOM.

Methods: In this double-blind, randomised study, we enrolled 383 patients aged 1-7 years who had had two or more episodes of AOM in the year before entry. Randomisation was stratified in four groups according to age (12-24 months vs 25-84 months) and the number of previous AOM episodes (two or three episodes vs four or more episodes). Children received either 7-valent pneumococcal conjugate vaccine followed by 23-valent pneumococcal polysaccharide vaccine, or hepatitis A or B vaccines. They were followed up for 18 months for recurrence of AOM. We also cultured samples of middle-ear fluid and nasopharyngeal swabs to assess association of pneumococcal serotypes with AOM after vaccination.

Findings: We noted no reduction of AOM episodes in the pneumococcal vaccine group compared with controls (intention-to-treat analysis: rate ratio 1.25, 95% CI 0.99-1.57). Although nasopharyngeal carriage of pneumococci of serotypes included in the conjugate-vaccine was greatly reduced after pneumococcal vaccinations, immediate and complete replacement by non-vaccine pneumococcal serotypes took place.

Interpretation: These data do not lend support to the use of pneumococcal conjugate vaccine to prevent otitis media in previously unvaccinated toddlers and children with a history of recurrent AOM.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Disease
  • Chi-Square Distribution
  • Child
  • Child, Preschool
  • Double-Blind Method
  • Female
  • Humans
  • Immunization, Secondary
  • Infant
  • Male
  • Nasal Mucosa / microbiology
  • Otitis Media / microbiology
  • Otitis Media / prevention & control*
  • Pharynx / microbiology
  • Pneumococcal Vaccines*
  • Proportional Hazards Models
  • Regression Analysis
  • Secondary Prevention
  • Serotyping
  • Streptococcus pneumoniae / classification
  • Treatment Outcome
  • Vaccines, Conjugate*


  • Pneumococcal Vaccines
  • Vaccines, Conjugate