Department of Paediatrics, Spaarne Hospital, Haarlem, Netherlands (R Veenhoven MD, C Brouwer MD, H Kiezebrink MD); Department of Paediatrics, Sophia Children's Hospital, Erasmus University, Rotterdam, Netherlands (D Bogaert MD, P Hermans PhD, Prof R de Groot MD); Julius Center for Health Sciences and Primary Care, Utrecht, Netherlands (C Uiterwaal MD); Regional Laboratory of Public Health, Haarlem (J Bruin MSc, E IJzerman MD); Department of Otorhinolaryngology (A Schilder MD), Laboratory of Paediatric Immunology (G Rijkers PhD, Prof B Zegers PhD), and Department of Paediatric Immunology (Prof W Kuis MD, E Sanders MD), Wilhelmina Children's Hospital, University Medical Center, Utrecht

Correspondence to: Dr E A M Sanders, Department of Paediatric Immunology, Wilhelmina Children's Hospital/University Medical Center Utrecht, PO Box 85090, 3508 AB Utrecht, Netherlands. (e-mail:eam.sanders@planet.nl)

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.

Lancet 2003; 361: 2189-95