***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
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    ***EXAMPLES*** 
    Input: Background : We investigated the efficacy and safety of 1 versus 2 doses of live attenuated influenza vaccine ( LAIV ) in influenza vaccine – naive children aged 6 to < 36 months . Patients / Methods : Subjects were r and omized to 1 of 4 regimens in year 1 : 2 doses LAIV , 1 dose LAIV , excipient placebo , or saline placebo . In year 2 , LAIV recipients were to receive 1 dose of LAIV and placebo recipients were to receive saline placebo . Because of an unintended treatment allocation error in year 2 , 1 block of subjects who were r and omized to LAIV received saline placebo and 1 block who were r and omized to placebo received LAIV . Results : In year 1 , vaccine efficacy versus placebo among recipients of 2 and 1 doses of LAIV was 73.5 % and 57.7 % , respectively , against antigenically similar strains . In year 2 , absolute efficacy of a single dose of LAIV was 73.6 % and 65.2 % , respectively , in recipients of 2 and 1 doses of LAIV in year 1 . Year 2 efficacy was 57.0 % in subjects who received 2 doses of LAIV in year 1 and placebo in year 2 . Safety and tolerability of LAIV were consistent with previous studies . Reactogenicity was similar between placebo groups . Seroconversion rates were significantly higher in the 2-dose versus the 1-dose LAIV group in year 1 and in both LAIV groups versus placebo in years 1 and 2 . Conclusions : One dose of LAIV provided clinical ly significant protection against influenza in young children previously unvaccinated against influenza ; 2 doses provided additional protection . Protection after 2 doses in year 1 persisted through a second season without revaccination . LAIV excipients were not a major contributor to reactogenicity . These benefits provide support for increased use of LAIV in children ≥2 years of age Objective . To determine the safety of cold-adapted trivalent intranasal influenza virus vaccine ( CAIV ) in children and adolescents . Study design . A r and omized , double blind , placebo-controlled safety trial in healthy children age 12 months to 17 years given CAIV ( FluMist ; MedImmune Vaccines , Inc. ) or placebo ( r and omization , 2:1 ) . Children < 9 years of age received a second dose of CAIV or placebo 28 to 42 days after the first dose . Enrolled children were then followed for 42 days after each vaccination for all medically attended events . Prespecified outcomes included 4 prespecified diagnostic groups and 170 observed individual diagnostic categories . The relative risk and the 2-sided 90 % confidence interval were calculated for each diagnostic group and individual category by clinical setting , dose and age . More than 1500 relative risk analyses were performed . Results . A total of 9689 evaluable children were enrolled in the study . Of the 4 prespecified diagnostic categories ( acute respiratory tract events , systemic bacterial infection , acute gastrointestinal tract events and rare events potentially associated with wild-type influenza ) , none was associated with vaccine . Of the biologically plausible individual diagnostic categories , 3 , acute gastrointestinal events , acute respiratory events and abdominal pain , had different analyses that demonstrated increased and decreased relative risks , making their association with the vaccine unlikely . For reactive airway disease a significant increased relative risk was observed in children 18 to 35 months of age with a relative risk of 4.06 ( 90 % confidence interval , 1.29 to 17.86 ) in this age group . The individual diagnostic categories of upper respiratory infection , musculoskeletal pain , otitis media with effusion and adenitis/adenopathy had at least one analysis that achieved a significant increased risk ratio . All of these events were infrequent . Conclusion . CAIV was generally safe in children and adolescents . The observation of an increased risk of asthma/reactive airway disease in children < 36 months of age is of potential concern . Further studies are planned to evaluate the risk of asthma/reactive airway disease after vaccine BACKGROUND Universal vaccination of children 6 to 59 months of age with trivalent inactivated influenza vaccine has recently been recommended by U.S. advisory bodies . To evaluate alternative vaccine approaches , we compared the safety and efficacy of intranasally administered live attenuated influenza vaccine with those of inactivated vaccine in infants and young children . METHODS Children 6 to 59 months of age , without a recent episode of wheezing illness or severe asthma , were r and omly assigned in a 1:1 ratio to receive either cold-adapted trivalent live attenuated influenza vaccine ( a refrigeration-stable formulation of live attenuated intranasally administered influenza vaccine ) or trivalent inactivated vaccine in a double-blind manner . Influenza-like illness was monitored with cultures throughout the 2004 - 2005 influenza season . RESULTS Safety data were available for 8352 children , and 7852 children completed the study according to the protocol . There were 54.9 % fewer cases of cultured-confirmed influenza in the group that received live attenuated vaccine than in the group that received inactivated vaccine ( 153 vs. 338 cases , P<0.001 ) . The superior efficacy of live attenuated vaccine , as compared with inactivated vaccine , was observed for both antigenically well-matched and drifted viruses . Among previously unvaccinated children , wheezing within 42 days after the administration of dose 1 was more common with live attenuated vaccine than with inactivated vaccine , primarily among children 6 to 11 months of age ; in this age group , 12 more episodes of wheezing were noted within 42 days after receipt of dose 1 among recipients of live attenuated vaccine ( 3.8 % ) than among recipients of inactivated vaccine ( 2.1 % , P=0.076 ) . Rates of hospitalization for any cause during the 180 days after vaccination were higher among the recipients of live attenuated vaccine who were 6 to 11 months of age ( 6.1 % ) than among the recipients of inactivated vaccine in this age group ( 2.6 % , P=0.002 ) . CONCLUSIONS Among young children , live attenuated vaccine had significantly better efficacy than inactivated vaccine . An evaluation of the risks and benefits indicates that live attenuated vaccine should be a highly effective , safe vaccine for children 12 to 59 months of age who do not have a history of asthma or wheezing . ( Clinical Trials.gov number , NCT00128167 [ Clinical Trials.gov ] . ) BACKGROUND Recommendations vary regarding immediate antimicrobial treatment versus watchful waiting for children younger than 2 years of age with acute otitis media . METHODS We r and omly assigned 291 children 6 to 23 months of age , with acute otitis media diagnosed with the use of stringent criteria , to receive amoxicillin-clavulanate or placebo for 10 days . We measured symptomatic response and rates of clinical failure . RESULTS Among the children who received amoxicillin-clavulanate , 35 % had initial resolution of symptoms by day 2 , 61 % by day 4 , and 80 % by day 7 ; among children who received placebo , 28 % had initial resolution of symptoms by day 2 , 54 % by day 4 , and 74 % by day 7 ( P=0.14 for the overall comparison ) . For sustained resolution of symptoms , the corresponding values were 20 % , 41 % , and 67 % with amoxicillin-clavulanate , as compared with 14 % , 36 % , and 53 % with placebo ( P=0.04 for the overall comparison ) . Mean symptom scores over the first 7 days were lower for the children treated with amoxicillin-clavulanate than for those who received placebo ( P=0.02 ) . The rate of clinical failure -- defined as the persistence of signs of acute infection on otoscopic examination -- was also lower among the children treated with amoxicillin-clavulanate than among those who received placebo : 4 % versus 23 % at or before the visit on day 4 or 5 ( P<0.001 ) and 16 % versus 51 % at or before the visit on day 10 to 12 ( P<0.001 ) . Mastoiditis developed in one child who received placebo .  Diarrhea and diaper-area dermatitis were more common among children who received amoxicillin-clavulanate . There were no significant changes in either group in the rates of nasopharyngeal colonization with nonsusceptible Streptococcus pneumoniae . CONCLUSIONS Among children 6 to 23 months of age with acute otitis media , treatment with amoxicillin-clavulanate for 10 days tended to reduce the time to resolution of symptoms and reduced the overall symptom burden and the rate of persistent signs of acute infection on otoscopic examination . ( Funded by the National Institute of Allergy and Infectious Diseases ; Clinical Trials.gov number , NCT00377260 . ) Background : Young children have a high incidence of influenza and influenza-related complications . This study compared the efficacy and safety of cold-adapted influenza vaccine , trivalent ( CAIV-T ) with trivalent inactivated influenza vaccine ( TIV ) in young children with a history of recurrent respiratory tract infections ( RTIs ) . Methods : Children 6 to 71 months of age were r and omized to receive 2 doses of CAIV-T ( n = 1101 ) or TIV ( n = 1086 ) , 35 ± 7 days apart before the start of the 2002–2003 influenza season and were followed up for culture-confirmed influenza , effectiveness outcomes , reactogenicity , and adverse events . Results : Overall , 52.7 % ( 95 % confidence interval [ CI ] = 21.6%–72.2 % ) fewer cases of influenza caused by virus strains antigenically similar to vaccine were observed in CAIV-T than in TIV recipients . Greater relative efficacy for CAIV-T was observed for the antigenically similar A/H1N1 ( 100.0 % ; 95 % CI = 42.3%–100.0 % ) and B ( 68.0 % ; 95 % CI = 37.3%–84.8 % ) strains but not for the antigenically similar A/H3N2 strains ( −97.1 % ; 95 % CI = −540.2 % to 31.5 % ) . Relative to TIV , CAIV-T reduced the number of RTI-related healthcare provider visits by 8.9 % ( 90 % CI = 1.5%–15.8 % ) and missed days of school , kindergarten , or day care by 16.2 % ( 90 % CI = 10.4%–21.6 % ) . Rhinitis and rhinorrhea , otitis media , and decreased appetite were the only events that were reported more frequently in CAIV-T subjects . There was no difference between groups in the incidence of wheezing after vaccination . Conclusions : CAIV-T was well tolerated in these children with RTIs and demonstrated superior relative efficacy compared with TIV in preventing influenza illness OBJECTIVE . The goal was to evaluate the safety , tolerability , and efficacy of an investigational , refrigerator-stable formulation of live attenuated influenza vaccine ( cold-adapted influenza vaccine-trivalent ) against culture-confirmed influenza , acute otitis media , and effectiveness outcomes in young children in day care over 2 consecutive influenza seasons . METHODS . Children 6 to < 36 months of age who were attending day care were assigned r and omly in year 1 to receive 2 doses of vaccine or placebo intranasally , 35 ± 7 days apart . In year 2 , subjects received 1 dose of the same treatment as in year 1 . RESULTS . A total of 1616 subjects ( vaccine : 951 subjects ; placebo : 665 subjects ) in year 1 and 1090 subjects ( vaccine : 640 subjects ; placebo : 450 subjects ) in year 2 were able to be evaluated for efficacy . The mean age at first vaccination was 23.4 ± 7.9 months . In year 1 , the overall efficacy of the vaccine against influenza subtypes similar to the vaccine was 85.4 % ; efficacy was 91.8 % against A/H1N1 and 72.6 % against B. In year 2 , the overall efficacy was 88.7 % ; efficacy was 90.0 % against H1N1 , 90.3 % against A/H3N2 , and 81.7 % against B. Efficacy against all episodes of acute otitis media associated with culture-confirmed influenza was 90.6 % in year 1 and 97.0 % in year 2 . Runny nose or nasal discharge after dose 1 in year 1 was the only reactogenicity event that was significantly more frequent with cold-adapted influenza vaccine-trivalent ( 82.3 % ) than placebo ( 75.4 % ) . CONCLUSIONS . Cold-adapted influenza 
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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 .
Influenza vaccine results in a small reduction in AOM .
The benefits may not justify the use of influenza vaccine without taking into account the vaccine efficacy in reducing influenza and safety data .