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Because viruses are frequently the ...Because viruses are frequently the etiologic agent in acute otitis media (AOM), it stands to reason that influenza vaccines might help obstruct some cases of AOM. Previous studies of AOM prevention with influenza vaccines have been limited on small sample size and flaws in investigation design. Hoberman and colleagues studied the preventive meaning of influenza vaccine on AOM in children aged six to 24 month Studying the vaccine's safety, immunogenicity, and efficacy against influenza were secondary aims of the study Enrollee were stratified according to whether they were otitis-prone and whether they attended day care. In undivided cohort, children also were stratified according to whether they had received at least individual dose of the newly available pneumococcal vaccine. Within each of these strata, children were randomized to influenza vaccine or placebo, given in sum of two units doses, four weeks apart. Office visits were arranged if patients lay opened any sign or symptom of AOM or upper respiratory infection. Throats were cultur for influenza virus if patients had signs or symptoms of upper respiratory infection accompanied by way of fever. Immunogenicity was assessed by the agency of blood samples, and safety by means of reporting of adverse events. A first cohort of 411 children and a inferior of 375 children were studied, with 373 and 346 completing the subject of attention respectively. Sero-conversion occurred in 886 percent to 968 percent of a representative subset In the first cohort, culture-proven influenza was identified in 15 (55 percent) of the 273 children in the vaccine cluster and 22 (15.9 percent) of the 138 children in the placebo cluster In the second cohort, the number of positive civilizations was nine (3.6 percent) of the 252 children in the vaccine assign places to and four (3.3 percent) of the 123 children in the placebo cluster Efficacy rates were 66 percent in the first cohort and -7 percent in the secondary In the first cohort, no differences were seen in the rate of upper respiratory infections between vaccinated and placebo form into groupss but in the second cohort, upper respiratory infection rates were actually higher in the vaccine clump than in the placebo assign places to during the influenza season and the respiratory season. In the first cohort, there were no differences between the vaccine collection and the placebo group in the proportion of children who had at least united episode of AOM. However, in a subgroup of patients aged 19 to 24 month the proportion of patients with individual episode of AOM was lower in the vaccine assign places to than in the placebo clump In the second cohort, there were no significant differences between disposes in the proportion of those with at least single in kind episode of AOM. There were no statistically significant differences in health care utilization between form into groupss The placement of tympanostomy tubes from one side of to the other the two-year study period occurr in 39 children in the vaccine assign places to and 12 children in the placebo clump Adverse events possibly related to the vaccine included single in kind episode of unexplained staring, single in kind child with mild wheezing, and the same child with gastroenteritis. In this consideration influenza vaccine did not appear to contract episodes of AOM, although a subset of children aged 19 to 24 month may have benefited. Influenza may be a les customary cause of upper respiratory infection in younger children. In addition, influenza vaccine may be les effective in preventing influenza and its complications in younger children. Nonetheless, the vaccine did appear to provide limited protection against influenza, and this reduction may justify giving the vaccine to infants and healthy young children, in accordance with the recommendations of the Advisory Committee forward Immunization Practices. CAROLINE WELLBERY, MD Hoberman A, et al. Effectiveness of inactivated influenza vaccine in preventing acute otitis media in young children. A randomized controll trial. JAMA September 24 2003;290:1608-16 COPYRIGHT 2004 American Academy of Family Physicians |
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