Abstract

Background: Knowledge about the effect of recurrent acute otitis media (rAOM) and its treatment on health-related quality of life (HRQoL) and functional health status (FHS) in children with rAOM is limited. The current study aims to assess the effect of pneumococcal vaccination on HRQoL and FHS in children aged 1–7 years with rAOM. Methods: In a double-blind randomized controlled trial, 383 children aged 1–7 years with rAOM were vaccinated with either heptavalent pneumococcal conjugate vaccine followed by pneumococcal polysaccharide vaccine (pneumococcal group, n=190), or hepatitis A or B vaccine (control group, n=193). At baseline, age-adjusted HRQoL and FHS scores of all children were compared to those of reference populations. Subsequently, scores of the pneumococcal and control vaccine group were compared at baseline and at 7, 14, and 26 months follow-up. Data are presented for two instruments, NRS Child and FSQ Generic, assessing HRQoL and FHS, respectively. Results: Scores on the FSQ Generic of children with rAOM were lower than those of healthy children and comparable to those of children with asthma. After vaccination, no differences on the FSQ Generic or NRS Child were found between the pneumococcal and the control group at baseline and during follow-up. Conclusions: Recurrent acute otitis media has a considerable impact on the HRQoL and FHS of children; however, pneumococcal vaccination had no beneficial effect on their HRQoL and FHS.

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