human
***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 
    ***DOCUMENTATION*** 
    ***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 Summary Background Live attenuated influenza vaccines have been shown to significantly reduce influenza in diverse population s of children , but no efficacy studies have been done in re source -poor tropical setting s. In Senegal , we assessed the efficacy and safety of a live attenuated influenza vaccine based on Russian-derived master donor viruses and licensed as a single dose . Methods In this double-blind , placebo-controlled , parallel group , single-centre trial done near Niakhar , Senegal , generally healthy children aged 2–5 years were r and omly allocated ( 2:1 ) to receive a single intranasal dose of masked trivalent live attenuated influenza vaccine or placebo . The allocation sequence was computer-generated by PATH with block sizes of three . The manufacturer provided vaccine and placebo in coded vials to preserve blinding . Participants were monitored through the predictable influenza season in Senegal for adverse events and signs and symptoms of influenza using weekly home visits and surveillance in clinics . The primary outcome was symptomatic laboratory-confirmed influenza caused by any strain and occurring from 15 days post-vaccination to the end of the study . The primary analysis was per protocol . This study is registered with Clinical Trials.gov , number NCT01854632 . Findings Between May 23 , and July 1 , 2013 , 1761 children were r and omly assigned , 1174 to receive live attenuated influenza vaccine and 587 to receive placebo .  The per- protocol set included 1173 vaccinees and 584 placebo recipients followed up to Dec 20 , 2013 . Symptomatic influenza was laboratory-confirmed in 210 ( 18 % ) of 1173 recipients of live attenuated influenza vaccine and 105 ( 18 % ) of placebo recipients , giving a vaccine efficacy of 0·0 % ( 95 % CI −26·4 to 20·9 ) . Adverse events were balanced between the study groups . Two girls who had received live attenuated influenza vaccine died , one due to anasarca 12 days postvaccination and one due to malnutrition 70 days postvaccination . Interpretation Live attenuated influenza vaccine was well tolerated in young children in Senegal , but did not provide protection against influenza . Further study in such population s , which might experience extended periods of influenza circulation , is warranted . Funding US Centers for Disease Control and Prevention and Bill & Melinda Gates Foundation Summary Background The rates of influenza illness and associated complications are high among children in Bangladesh . We assessed the clinical efficacy and safety of a Russian-backbone live attenuated influenza vaccine ( LAIV ) at two field sites in Bangladesh . Methods Between Feb 27 and April 9 , 2013 , children aged 2–4 years in urban Kamalapur and rural Matlab , Bangladesh , were r and omly assigned in a 2:1 ratio , according to a computer-generated schedule , to receive one intranasal dose of LAIV or placebo . After vaccination , we monitored children in weekly home visits until Dec 31 , 2013 , with study clinic surveillance for influenza illness . The primary outcome was symptomatic , laboratory-confirmed influenza illness due to vaccine-matched strains . Analysis was per protocol . The trial is registered with Clinical Trials.gov , number NCT01797029 . Findings Of 1761 children enrolled , 1174 received LAIV and 587 received placebo .  Laboratory-confirmed influenza illness due to vaccine-matched strains was seen in 93 ( 15·8 % ) children in the placebo group and 79 ( 6·7 % ) in the LAIV group . Vaccine efficacy of LAIV for vaccine-matched strains was 57·5 % ( 95 % CI 43·6–68·0 ) . The vaccine was well tolerated , and adverse events were balanced between the groups . The most frequent adverse events were tachypnoea ( n=86 in the LAIV group and n=54 in the placebo group ) , cough ( n=73 and n=43 ) , and runny nose ( n=68 and n=39 ) , most of which were mild . Interpretation This single-dose Russian-backbone LAIV was safe and efficacious at preventing symptomatic laboratory-confirmed influenza illness due to vaccine-matched strains . LAIV programmes might reduce the burden of influenza illness in Bangladesh . Funding The Bill & Melinda Gates Foundation Background . During the 2012–2013 influenza season , there was cocirculation of influenza A(H3N2 ) and 2 influenza B lineage viruses in the United States . Methods . Patients with acute cough illness for ≤7 days were prospect ively enrolled and had swab sample s obtained at outpatient clinics in 5 states .  Influenza vaccination date s were confirmed by medical records . The vaccine effectiveness ( VE ) was estimated as [ 100 % × ( 1 − adjusted odds ratio ) ] for vaccination in cases versus test-negative controls . Results . Influenza was detected in 2307 of 6452 patients ( 36 % ) ; 1292 ( 56 % ) had influenza A(H3N2 ) , 582 ( 25 % ) had influenza B/Yamagata , and 303 ( 13 % ) had influenza B/Victoria . VE was 49 % ( 95 % confidence interval [ CI ] , 43%–55 % ) overall , 39 % ( 95 % CI , 29%–47 % ) against influenza A(H3N2 ) , 66 % ( 95 % CI , 58%–73 % ) against influenza B/Yamagata ( vaccine lineage ) , and 51 % ( 95 % CI , 36%–63 % ) against influenza B/Victoria . VE against influenza A(H3N2 ) was highest among persons aged 50–64 years ( 52 % ; 95 % CI , 33%–65 % ) and persons aged 6 months–8 years ( 51 % ; 95 % CI , 32%–64 % ) and lowest among persons aged ≥65 years ( 11 % ; 95 % CI , −41 % to 43 % ) . In younger age groups , there was evidence of residual protection from receipt of the 2011–2012 vaccine 1 year earlier . Conclusions . The 2012–2013 vaccines were moderately effective in most age groups . Cross-lineage protection and residual effects from prior vaccination were observed and warrant further investigation 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 : 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 R 
    Output:
    
agent
***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 
    ***DOCUMENTATION*** 
    ***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 Summary Background Live attenuated influenza vaccines have been shown to significantly reduce influenza in diverse population s of children , but no efficacy studies have been done in re source -poor tropical setting s. In Senegal , we assessed the efficacy and safety of a live attenuated influenza vaccine based on Russian-derived master donor viruses and licensed as a single dose . Methods In this double-blind , placebo-controlled , parallel group , single-centre trial done near Niakhar , Senegal , generally healthy children aged 2–5 years were r and omly allocated ( 2:1 ) to receive a single intranasal dose of masked trivalent live attenuated influenza vaccine or placebo . The allocation sequence was computer-generated by PATH with block sizes of three . The manufacturer provided vaccine and placebo in coded vials to preserve blinding . Participants were monitored through the predictable influenza season in Senegal for adverse events and signs and symptoms of influenza using weekly home visits and surveillance in clinics . The primary outcome was symptomatic laboratory-confirmed influenza caused by any strain and occurring from 15 days post-vaccination to the end of the study . The primary analysis was per protocol . This study is registered with Clinical Trials.gov , number NCT01854632 . Findings Between May 23 , and July 1 , 2013 , 1761 children were r and omly assigned , 1174 to receive live attenuated influenza vaccine and 587 to receive placebo .  The per- protocol set included 1173 vaccinees and 584 placebo recipients followed up to Dec 20 , 2013 . Symptomatic influenza was laboratory-confirmed in 210 ( 18 % ) of 1173 recipients of live attenuated influenza vaccine and 105 ( 18 % ) of placebo recipients , giving a vaccine efficacy of 0·0 % ( 95 % CI −26·4 to 20·9 ) . Adverse events were balanced between the study groups . Two girls who had received live attenuated influenza vaccine died , one due to anasarca 12 days postvaccination and one due to malnutrition 70 days postvaccination . Interpretation Live attenuated influenza vaccine was well tolerated in young children in Senegal , but did not provide protection against influenza . Further study in such population s , which might experience extended periods of influenza circulation , is warranted . Funding US Centers for Disease Control and Prevention and Bill & Melinda Gates Foundation Summary Background The rates of influenza illness and associated complications are high among children in Bangladesh . We assessed the clinical efficacy and safety of a Russian-backbone live attenuated influenza vaccine ( LAIV ) at two field sites in Bangladesh . Methods Between Feb 27 and April 9 , 2013 , children aged 2–4 years in urban Kamalapur and rural Matlab , Bangladesh , were r and omly assigned in a 2:1 ratio , according to a computer-generated schedule , to receive one intranasal dose of LAIV or placebo . After vaccination , we monitored children in weekly home visits until Dec 31 , 2013 , with study clinic surveillance for influenza illness . The primary outcome was symptomatic , laboratory-confirmed influenza illness due to vaccine-matched strains . Analysis was per protocol . The trial is registered with Clinical Trials.gov , number NCT01797029 . Findings Of 1761 children enrolled , 1174 received LAIV and 587 received placebo .  Laboratory-confirmed influenza illness due to vaccine-matched strains was seen in 93 ( 15·8 % ) children in the placebo group and 79 ( 6·7 % ) in the LAIV group . Vaccine efficacy of LAIV for vaccine-matched strains was 57·5 % ( 95 % CI 43·6–68·0 ) . The vaccine was well tolerated , and adverse events were balanced between the groups . The most frequent adverse events were tachypnoea ( n=86 in the LAIV group and n=54 in the placebo group ) , cough ( n=73 and n=43 ) , and runny nose ( n=68 and n=39 ) , most of which were mild . Interpretation This single-dose Russian-backbone LAIV was safe and efficacious at preventing symptomatic laboratory-confirmed influenza illness due to vaccine-matched strains . LAIV programmes might reduce the burden of influenza illness in Bangladesh . Funding The Bill & Melinda Gates Foundation Background . During the 2012–2013 influenza season , there was cocirculation of influenza A(H3N2 ) and 2 influenza B lineage viruses in the United States . Methods . Patients with acute cough illness for ≤7 days were prospect ively enrolled and had swab sample s obtained at outpatient clinics in 5 states .  Influenza vaccination date s were confirmed by medical records . The vaccine effectiveness ( VE ) was estimated as [ 100 % × ( 1 − adjusted odds ratio ) ] for vaccination in cases versus test-negative controls . Results . Influenza was detected in 2307 of 6452 patients ( 36 % ) ; 1292 ( 56 % ) had influenza A(H3N2 ) , 582 ( 25 % ) had influenza B/Yamagata , and 303 ( 13 % ) had influenza B/Victoria . VE was 49 % ( 95 % confidence interval [ CI ] , 43%–55 % ) overall , 39 % ( 95 % CI , 29%–47 % ) against influenza A(H3N2 ) , 66 % ( 95 % CI , 58%–73 % ) against influenza B/Yamagata ( vaccine lineage ) , and 51 % ( 95 % CI , 36%–63 % ) against influenza B/Victoria . VE against influenza A(H3N2 ) was highest among persons aged 50–64 years ( 52 % ; 95 % CI , 33%–65 % ) and persons aged 6 months–8 years ( 51 % ; 95 % CI , 32%–64 % ) and lowest among persons aged ≥65 years ( 11 % ; 95 % CI , −41 % to 43 % ) . In younger age groups , there was evidence of residual protection from receipt of the 2011–2012 vaccine 1 year earlier . Conclusions . The 2012–2013 vaccines were moderately effective in most age groups . Cross-lineage protection and residual effects from prior vaccination were observed and warrant further investigation 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 : 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 R 
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