Background. Limited effectiveness of current treatment strategies for recurrent acute otitis media (RAOM) and increasing antibiotic resistance have diverted attention to prevention of AOM by vaccination. Pneumococcal vaccination for AOM seems to have only modest clinical efficacy. Thus far, the effects on health-related quality of life (HRQoL) or functional health status (FHS) have not been studied.

Objective. To assess the effect of vaccination on HRQoL or FHS.

Methods. In a double-blind, randomized, controlled trial, 383 children 1 to 7 years old with RAOM were vaccinated with either heptavalent pneumococcal conjugate vaccine followed by pneumococcal polysaccharide vaccine (pneumococcal group: n = 190) or with hepatitis A or B vaccines (control group: n = 193). Parents completed validated Dutch versions of 8 HRQoL and FHS instruments assessing generic FHS (Rand, Functional Status Questionnaire specific, and Functional Status Questionnaire generic), otitis media–specific FHS (OM-6), otitis media–specific child HRQoL (Numerical Rating Scale for Child), family functioning (Family Functioning Questionnaire), and otitis media–specific caregiver HRQoL (Numerical Rating Scale for Caregiver). Scores were compared at baseline and at 14 and 26 months' follow-up.

Results. At baseline, the average AOM incidence in the pneumococcal and control group was 5.0 (SD: 2.8) and 4.9 (SD: 2.6) episodes per year, respectively, with 38.4% and 36.8% having suffered from ≥6 episodes per year. AOM frequency decreased 4.4 episodes per year in both groups, with a considerable and comparable improvement in HRQoL and FHS. No substantial differences in HRQoL or FHS were found between the pneumococcal and the control group at baseline or at 14 or 26 months' follow-up.

Conclusion. Pneumococcal vaccination has no beneficial effect compared with control vaccination on either HRQoL or FHS in children 1 to 7 years old with RAOM.

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