Background.Limited effectiveness of current treatment strategies for recurren t acute otitis media(RAOM)and increasing antibiotic resistance have diverted a ttention to prevention of AOM by vaccination.Pneumococcal vaccination for AOM s eems to have only modest clinical efficacy.Thus far,the effects on healthrelat ed quality of life(HRQoL)or functional health status(FHS)have not been studi ed.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 wit h RAOM were vaccinated with either heptavalent pneumococcal conjugate vaccine fo llowed by pneumococcal polysaccharide vaccine(pneumococcal group:n = 190)or w ith hepatitis A or B vaccines(control group:n = 193).Parents completed valida ted Dutch versions of 8 HRQoL and FHS instruments assessing generic FHS(Rand,F unctional Status Questionnaire specific,and Functional Status Questionnaire gen eric),otitis media-specific FHS(OM-6),otitis media-specific child HRQoL(N umerical Rating Scale for Child),family functioning(Family Functioning Questio nnaire),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 contro l group was 5.0(SD:2.8)and 4.9(SD:2.6)episodes per year,respectively,wit h 38.4%and 36.8%having suffered from ≥6 episodes per year.AOM frequency decr eased 4.4 episodes per year in both groups,with a considerable and comparable i mprovement in HRQoL and FHS.No substantial differences in HRQoL or FHS were fou nd between the pneumococcal and the control group at baseline or at 14 or 26 mon ths’follow-up.Conclusion.Pneumococcal vaccination has no beneficial effect c ompared with control vaccination on either HRQoL or FHS in children 1 to 7 years old with RAOM. Background. Limited effectiveness of current treatment strategies for recurren t acute otitis media (RAOM) and increasing antibiotic resistance have diverted a ttention to prevention of AOM by vaccination. Pneumococcal vaccination for A emers to have only modest clinical efficacy. Thus far, the effects on healthrelat ed quality of life (HRQoL) or functional health status (FHS) have not been studi ed. Objectives assess the effect of vaccination on HRQoL or FHS.Methods.In a double-blind, randomized, controlled trial, 383 children 1 to 7 years old wit h RAOM were vaccinated with either heptavalent pneumococcal conjugate vaccine fo llowed by pneumococcal polysaccharide vaccine (pneumococcal group: n = 190) or w ith hepatitis A or B vaccines (control group: n = 193) .Parents completed valida ted Dutch versions of 8 HRQoL and FHS instruments assessing generic FHS (Rand, F unctional Status Questionnaire specific and and Functional Status Questionnaire gen eric), otitis media-specific FHS (OM-6), otitis media-specifi c Child HRQoL (Good Scale Scale for Child), family functioning (Family Functioning Quesnitio), 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 contro l group was 5.0 (SD: 2.8) and 4.9 (SD: 2.6) episodes per year, respectively, wit h 38.4% and 36.8% having suffered from ≥6 episodes per year in both groups, with a considerable and comparable i mprovement in HRQoL and FHS. Novel differences in HRQoL or FHS were fou nd between the pneumococcal and the control group at baseline or at 14 or 26 mon ths’follow-up.Conclusion. Pneumococcal vaccination has no beneficial effect c ompared with control vaccination on either HRQoL or FHS in children 1 to 7 years old with RAOM.