We did not perform a subgroup analysis due to the limited number of studies reporting season. Acute otitis media by type of vaccine Of the four studies that reported the outcome of at least one episode of AOM during the follow\up period, only two types of vaccine were used, trivalent cold\adapted vaccine, in Lum PDK1 inhibitor 2010 and Vesikari 2006, and trivalent subvirion vaccines, in Clements 1995 and Hoberman 2003. Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, LILACS, Web of Science, the WHO International Clinical Trials Registry Platform, and ClinicalTrials.gov (15 February 2017). We also searched the reference lists of included studies to identify any additional trials. Selection criteria Randomised controlled trials comparing influenza vaccine with placebo or no treatment in infants and children aged younger than six years. We included children of either sex and of any ethnicity, with or without a history of recurrent AOM. Data collection and analysis Two review authors independently screened studies, assessed trial quality, and extracted data. We performed statistical analyses using the random\effects and fixed\effect models and expressed the results as risk ratio (RR), risk difference (RD), and number needed to treat for an additional beneficial outcome (NNTB) for dichotomous outcomes, with 95% confidence intervals (CI). Main results We included 11 trials (6 trials in high\income countries and 5 multicentre trials in high\, middle\, and low\income countries) involving 17,123 children aged 6 months to 6 years. Eight trials recruited participants from a healthcare setting. Ten trials (and all four trials that contributed to the primary outcome) declared funding from vaccine manufacturers. Four trials reported adequate allocation concealment, and 10 trials reported adequate blinding of participants and personnel. Attrition was low for eight trials included in the analysis. The primary outcome showed a small reduction in at least one episode of AOM over at least six months of follow\up (4 trials, 3134 children; RR 0.84, 95% CI 0.69 to 1 1.02; RD \0.04, 95% CI \0.08 to \0.00; NNTB 25, 95% CI 12.5 PDK1 inhibitor to PDK1 inhibitor 100; low\quality evidence). The subgroup analyses (i.e. number of courses and types of vaccine administered) showed no differences. There was a reduction in the use of antibiotics in vaccinated children (2 trials, 1223 children; RR 0.70, 95% CI 0.59 to 0.83; RD \0.11, 95% CI \0.16 to \0.06; moderate\quality evidence). We were unable to demonstrate whether there was any difference in the utilisation of health care. The use of influenza vaccine resulted in a significant increase in fever (7 trials, 10,615 children; RR 1.15, 95% CI 1.06 to 1 1.24; RD 0.02, 95% CI 0.00 to 0.04; low\quality evidence), rhinorrhoea (6 trials, 10,563 children; RR 1.17, 95% CI 1.07 to 1 1.29; RD 0.09, 95% CI 0.01 to 0.16; low\quality evidence), but no difference in pharyngitis. No major adverse events were reported. Differing from the protocol, the original publication of the review included a subgroup analysis of AOM episodes by season, and the secondary outcome types of influenza vaccine was changed to a subgroup analysis. For this update, we removed the subgroup analyses for trial setting, season, and utilisation of health care due to the small number of trials involved. We removed Belshe 2000 from primary and secondary outcomes (courses of vaccine and types of vaccine) because it reported episodes of AOM per person. We did not perform a subgroup analysis by type of adverse event. We have reported each type of adverse event as a separate analysis. Authors’ conclusions Influenza vaccine results in a small reduction in AOM. The observed reduction in the use of antibiotics needs to be considered in light of current recommended practices aimed at avoiding antibiotic overuse. Safety data from these trials were limited. The benefits may not justify the use of influenza vaccine without taking into account PDK1 inhibitor the vaccine efficacy in reducing influenza and safety data. We judged the quality of the evidence to be low to moderate. Additional research is needed. Plain language summary Influenza vaccine for preventing acute otitis media (middle ear infection) Review question We reviewed the effect of influenza vaccine on preventing acute otitis media (AOM) in infants and children. Background Acute otitis media is one of the Mouse monoclonal to CD152 most common infectious diseases in infants and preschool children. Symptoms include ear pain and fever, but it may also cause hearing loss due to eardrum perforation or fluid accumulation in the middle ear. Acute otitis media is usually bacterial in origin and is often treated with antibiotics, which may carry the risk of antibiotic resistance. Even so,.
We did not perform a subgroup analysis due to the limited number of studies reporting season