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: OBJECTIVE . Immunization against rotavirus has been proposed as the most cost-effective intervention to reduce the disease burden associated with this infection worldwide . The objective of this study was to determine the dose response , immunogenicity , and efficacy of 2 doses of an oral , attenuated monovalent G1[P8 ] human rotavirus vaccine in children from the same setting in Mexico , where the natural protection against rotavirus infection was studied . METHODS . From June 2001 through May 2003 , 405 healthy infants were r and omly assigned to 1 of 3 vaccine groups ( virus concentrations 104.7 , 105.2 , and 105.8 infectious units ) and to a  placebo group and were monitored to the age of 2 years . The vaccine/placebo was administered concurrently with diphtheria-tetanus toxoid-pertussis/hepatitis B/Haemophilus influenzae type b vaccine at 2 and 4 months of age . After the administration of the first vaccine/placebo dose , weekly home visits to collect information regarding infant health were conducted . Stool sample s were collected during each gastroenteritis episode and tested for rotavirus antigen and serotype . RESULTS . The vaccine was well tolerated and induced a greater rate of seroconversion than observed in infants who received placebo . For the pooled vaccine groups , efficacy after 2 oral doses was 80 % and 95 % against any and severe rotavirus gastroenteritis , respectively . Efficacy was 100 % against severe rotavirus gastroenteritis and 70 % against severe gastroenteritis of any cause with the vaccine at the highest virus concentration ( 105.8 infectious units ) . The predominant infecting rotavirus serotype in this cohort was wild-type G1 ( 85 % ) . Adverse events , including fever , irritability , loss of appetite , cough , diarrhea , and vomiting , were similar among vaccinees and placebo recipients . CONCLUSION . This new oral , live , attenuated human rotavirus vaccine was safe , immunogenic , and highly efficacious in preventing any and , more importantly , severe rotavirus gastroenteritis in healthy infants . This vaccine produced comparable protection to natural infection BACKGROUND Rotavirus is the most common cause of severe gastroenteritis among young children worldwide . Data are needed to assess the efficacy of the rotavirus vaccine in African children . METHODS We conducted a r and omized , placebo-controlled , multicenter trial in South Africa ( 3166 infants ; 64.1 % of the total ) and Malawi ( 1773 infants ; 35.9 % of the total ) to evaluate the efficacy of a live , oral rotavirus vaccine in preventing severe rotavirus gastroenteritis . Healthy infants were r and omly assigned in a 1:1:1 ratio to receive two doses of vaccine ( in addition to one dose of placebo ) or three doses of vaccine - the pooled vaccine group - or three doses of placebo at 6 , 10 , and 14 weeks of age . Episodes of gastroenteritis caused by wild-type rotavirus during the first year of life were assessed through active follow-up surveillance and were grade d with the use of the Vesikari scale . RESULTS A total of 4939 infants were enrolled and r and omly assigned to one of the three groups ; 1647 infants received two doses of the vaccine , 1651 infants received three doses of the vaccine , and 1641 received placebo . Of the 4417 infants included in the per- protocol efficacy analysis , severe rotavirus gastroenteritis occurred in 4.9 % of the infants in the placebo group and in 1.9 % of those in the pooled vaccine group ( vaccine efficacy , 61.2 % ; 95 % confidence interval , 44.0 to 73.2 ) . Vaccine efficacy was lower in Malawi than in South Africa ( 49.4 % vs. 76.9 % ) ; however , the number of episodes of severe rotavirus gastroenteritis that were prevented was greater in Malawi than in South Africa ( 6.7 vs. 4.2 cases prevented per 100 infants vaccinated per year ) . Efficacy against all-cause severe gastroenteritis was 30.2 % . At least one serious adverse event was reported in 9.7 % of the infants in the pooled vaccine group and in 11.5 % of the infants in the placebo group . CONCLUSIONS Human rotavirus vaccine significantly reduced the incidence of severe rotavirus gastroenteritis among African infants during the first year of life . ( Clinical Trials.gov number , NCT00241644 . ) Background : Mexico initiated mass vaccination with the attenuated human rotavirus vaccine ( Rotarix ) in 2006 . This postlicensure study aim ed to assess any potential temporal association between vaccination and intussusception in Mexican infants . Methods : Prospect i ve , active surveillance for intussusception among infants aged less than 1 year was conducted in 221 hospitals across Mexico from the Mexican Institute of Social Security between January 2008 and October 2010 . The temporal association between vaccination and intussusception was assessed by self-controlled case-series analysis . Results : Of the 753 episodes of intussusception reported in 750 infants , 701 were in vaccinated infants ( 34.5 % post – dose 1 , 65.5 % post – dose 2 ) . The relative incidence of intussusception within 31 days of vaccination was 1.75 ( 95.5 % confidence interval [ CI ] : 1.24–2.48 ; P = 0.001 ) post – dose 1 and 1.06 ( 95.5 % CI : 0.75–1.48 ; P = 0.75 ) post – dose 2 . The relative incidence of intussusception within 7 days of vaccination was 6.49 post – dose 1 ( 95.5 % CI : 4.17–10.09 ; P < 0.001 ) and 1.29 post – dose 2 ( 95.5 % CI : 0.80–2.11 ; P = 0.29 ) . Clustering of intussusception within 7 days of vaccination was observed post – dose 1 . An attributable risk of 3 to 4 additional cases of intussusception per 100,000 vaccinated infants was estimated . Conclusion : This is the largest surveillance study for intussusception after rotavirus vaccination to date . A temporal increase in the risk for intussusception was seen within 7 days of administration of the first vaccine dose . It is still uncertain whether rotavirus vaccination has any impact on the overall incidence of intussusception . This finding has to be put in perspective with the well-documented substantial benefits of rotavirus vaccination OBJECTIVE To determine the safety , immunogenicity and efficacy of two doses of rotavirus vaccine in healthy Brazilian infants . METHODS A r and omized , multicenter , double-blind , placebo-controlled trial was conducted in Brazil , Mexico and Venezuela . Infants received two oral doses of vaccine or placebo at 2 and 4 months of age , concurrently with routine immunizations , except for oral poliomyelitis vaccine ( OPV ) . This paper reports results from Belém , Brazil , where the number of subjects per group and the viral vaccine titers were : 194 ( 10(4.7 ) focus forming units - FFU ) , 196 ( 10(5.2 ) FFU ) , 194 ( 10(5.8 ) FFU ) and 194 ( placebo ) . Anti-rotavirus ( anti-RV ) antibody response was assessed in 307 subjects .  Clinical severity of gastroenteritis episodes was measured using a 20-point scoring system with a score of > or= 11 defined as severe GE . RESULTS The rates of solicited general symptoms were similar in vaccine and placebo recipients . At 2 months after the second dose , a serum IgA response to RV occurred in 54.7 to 74.4 % of vaccinees . No interference was seen in the immunogenicity of routine vaccines . Vaccine efficacy against any rotavirus gastroenteritis ( RVGE ) was 63.5 % ( 95%CI 20.8 - 84.4 ) for the highest concentration ( 10(5.8 ) FFU ) . Efficacy was 81.5 % ( 95%CI 44.5 - 95.4 ) against severe RVGE . At its highest concentration ( 10(5.8 ) FFU ) , RIX4414 provided 79.8 % ( 95%CI 26.4 - 96.3 ) protection against severe RVGE by G9 strain . CONCLUSIONS RIX4414 was highly immunogenic with a low reactogenicity profile and did not interfere with seroresponse to diphtheria , tetanus , pertussis , hepatitis B and Hib antigens . Two doses of RIX4414 provided significant protection against severe GE caused by RV BACKGROUND The safety and efficacy of an attenuated G1P[8 ] human rotavirus ( HRV ) vaccine were tested in a r and omized , double-blind , phase 3 trial . METHODS We studied 63,225 healthy infants from 11 Latin American countries and Finl and who received two oral doses of either the HRV vaccine ( 31,673 infants ) or placebo ( 31,552 infants ) at approximately two months and four months of age . Severe gastroenteritis episodes were identified by active surveillance . The severity of disease was grade d with the use of the 20-point Vesikari scale . Vaccine efficacy was evaluated in a subgroup of 20,169 infants ( 10,159 vaccinees and 10,010 placebo recipients ) . RESULTS The efficacy of the vaccine against severe rotavirus gastroenteritis and against rotavirus-associated hospitalization was 85 percent ( P<0.001 for the comparison with placebo ) and reached 100 percent against more severe rotavirus gastroenteritis . Hospitalization for diarrhea of any cause was reduced by 42 percent ( 95 percent confidence interval , 29 to 53 percent ; P<0.001 ) . During the 31-day window after each dose , six vaccine recipients and seven placebo recipients had definite intussusception ( difference in risk , -0.32 per 10,000 infants ; 95 percent confidence interval , -2.91 to 2.18 ; P=0.78 ) . CONCLUSIONS Two oral doses of the live attenuated G1P[8 ] HRV vaccine were highly efficacious in protecting infants against severe rotavirus gastroenteritis , significantly reduced the rate of severe gastroenteritis from any cause , and were not associated with an increased risk of intussusception . ( Clinical Trials.gov numbers , NCT00139347 and NCT00263666 . Background : A live attenuated monovalent rotavirus vaccine RIX4414 was developed with a human strain of G1P1A P[8 ] specificity to reduce the rotavirus burden in children . Methods : A double blind , r and omized , placebo-controlled study evaluated the efficacy , immunogenicity , safety and reactogenicity of 2 oral doses of RIX4414 ( 104.7 , 105.2 or 105.8 focus-forming units ) at 2 and 4 months coadministered with routine vaccinations and oral poliovirus vaccine given for study purpose s at least 14 days apart . The 2155 infants ( 1618 vaccine/537 placebo ) enrolled in Brazil , Mexico and Venezuela were followed until 1 year of age . Results : Antirotavirus IgA seroconversion rates 2 months after dose 2 ranged between 61 % ( 10 4.7 ffu group ) and 65 % ( 105.8 ffu group ) , and most of the infants had seroprotective levels of antibodies to coadministered routine vaccinations . The reactogenicity profile of RIX4414 was similar to that of the placebo , and no vaccination-related serious adverse events were reported . Protective efficacy against severe and any rotavirus gastroenteritis from 15 days post-dose 2 was highest in the 105.8 ffu group [ 86 % ; 95 % confidence interval ( 95 % CI ) , 63–96 % and 70 % ( 95 % CI 46–84 % ) , P < 0.001 , 2-sided Fisher 's exact test ] . The efficacy against hospitalization was 79 % ( 95 % CI 48–92 % ) for pooled vaccine groups . Multiple rotavirus serotypes [ G1 ( 50 % ) , G9 ( 40 % ) , G2 , G3 and G4 ] were identified from gastroenteritis stools ( enzyme-linked immunosorbent assay and reverse transcription-polymerase chain reaction ) during the study period . For severe gastroenteritis caused by G9 serotypes , the protection reached 77 % ( 95 % CI  
    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: OBJECTIVE . Immunization against rotavirus has been proposed as the most cost-effective intervention to reduce the disease burden associated with this infection worldwide . The objective of this study was to determine the dose response , immunogenicity , and efficacy of 2 doses of an oral , attenuated monovalent G1[P8 ] human rotavirus vaccine in children from the same setting in Mexico , where the natural protection against rotavirus infection was studied . METHODS . From June 2001 through May 2003 , 405 healthy infants were r and omly assigned to 1 of 3 vaccine groups ( virus concentrations 104.7 , 105.2 , and 105.8 infectious units ) and to a  placebo group and were monitored to the age of 2 years . The vaccine/placebo was administered concurrently with diphtheria-tetanus toxoid-pertussis/hepatitis B/Haemophilus influenzae type b vaccine at 2 and 4 months of age . After the administration of the first vaccine/placebo dose , weekly home visits to collect information regarding infant health were conducted . Stool sample s were collected during each gastroenteritis episode and tested for rotavirus antigen and serotype . RESULTS . The vaccine was well tolerated and induced a greater rate of seroconversion than observed in infants who received placebo . For the pooled vaccine groups , efficacy after 2 oral doses was 80 % and 95 % against any and severe rotavirus gastroenteritis , respectively . Efficacy was 100 % against severe rotavirus gastroenteritis and 70 % against severe gastroenteritis of any cause with the vaccine at the highest virus concentration ( 105.8 infectious units ) . The predominant infecting rotavirus serotype in this cohort was wild-type G1 ( 85 % ) . Adverse events , including fever , irritability , loss of appetite , cough , diarrhea , and vomiting , were similar among vaccinees and placebo recipients . CONCLUSION . This new oral , live , attenuated human rotavirus vaccine was safe , immunogenic , and highly efficacious in preventing any and , more importantly , severe rotavirus gastroenteritis in healthy infants . This vaccine produced comparable protection to natural infection BACKGROUND Rotavirus is the most common cause of severe gastroenteritis among young children worldwide . Data are needed to assess the efficacy of the rotavirus vaccine in African children . METHODS We conducted a r and omized , placebo-controlled , multicenter trial in South Africa ( 3166 infants ; 64.1 % of the total ) and Malawi ( 1773 infants ; 35.9 % of the total ) to evaluate the efficacy of a live , oral rotavirus vaccine in preventing severe rotavirus gastroenteritis . Healthy infants were r and omly assigned in a 1:1:1 ratio to receive two doses of vaccine ( in addition to one dose of placebo ) or three doses of vaccine - the pooled vaccine group - or three doses of placebo at 6 , 10 , and 14 weeks of age . Episodes of gastroenteritis caused by wild-type rotavirus during the first year of life were assessed through active follow-up surveillance and were grade d with the use of the Vesikari scale . RESULTS A total of 4939 infants were enrolled and r and omly assigned to one of the three groups ; 1647 infants received two doses of the vaccine , 1651 infants received three doses of the vaccine , and 1641 received placebo . Of the 4417 infants included in the per- protocol efficacy analysis , severe rotavirus gastroenteritis occurred in 4.9 % of the infants in the placebo group and in 1.9 % of those in the pooled vaccine group ( vaccine efficacy , 61.2 % ; 95 % confidence interval , 44.0 to 73.2 ) . Vaccine efficacy was lower in Malawi than in South Africa ( 49.4 % vs. 76.9 % ) ; however , the number of episodes of severe rotavirus gastroenteritis that were prevented was greater in Malawi than in South Africa ( 6.7 vs. 4.2 cases prevented per 100 infants vaccinated per year ) . Efficacy against all-cause severe gastroenteritis was 30.2 % . At least one serious adverse event was reported in 9.7 % of the infants in the pooled vaccine group and in 11.5 % of the infants in the placebo group . CONCLUSIONS Human rotavirus vaccine significantly reduced the incidence of severe rotavirus gastroenteritis among African infants during the first year of life . ( Clinical Trials.gov number , NCT00241644 . ) Background : Mexico initiated mass vaccination with the attenuated human rotavirus vaccine ( Rotarix ) in 2006 . This postlicensure study aim ed to assess any potential temporal association between vaccination and intussusception in Mexican infants . Methods : Prospect i ve , active surveillance for intussusception among infants aged less than 1 year was conducted in 221 hospitals across Mexico from the Mexican Institute of Social Security between January 2008 and October 2010 . The temporal association between vaccination and intussusception was assessed by self-controlled case-series analysis . Results : Of the 753 episodes of intussusception reported in 750 infants , 701 were in vaccinated infants ( 34.5 % post – dose 1 , 65.5 % post – dose 2 ) . The relative incidence of intussusception within 31 days of vaccination was 1.75 ( 95.5 % confidence interval [ CI ] : 1.24–2.48 ; P = 0.001 ) post – dose 1 and 1.06 ( 95.5 % CI : 0.75–1.48 ; P = 0.75 ) post – dose 2 . The relative incidence of intussusception within 7 days of vaccination was 6.49 post – dose 1 ( 95.5 % CI : 4.17–10.09 ; P < 0.001 ) and 1.29 post – dose 2 ( 95.5 % CI : 0.80–2.11 ; P = 0.29 ) . Clustering of intussusception within 7 days of vaccination was observed post – dose 1 . An attributable risk of 3 to 4 additional cases of intussusception per 100,000 vaccinated infants was estimated . Conclusion : This is the largest surveillance study for intussusception after rotavirus vaccination to date . A temporal increase in the risk for intussusception was seen within 7 days of administration of the first vaccine dose . It is still uncertain whether rotavirus vaccination has any impact on the overall incidence of intussusception . This finding has to be put in perspective with the well-documented substantial benefits of rotavirus vaccination OBJECTIVE To determine the safety , immunogenicity and efficacy of two doses of rotavirus vaccine in healthy Brazilian infants . METHODS A r and omized , multicenter , double-blind , placebo-controlled trial was conducted in Brazil , Mexico and Venezuela . Infants received two oral doses of vaccine or placebo at 2 and 4 months of age , concurrently with routine immunizations , except for oral poliomyelitis vaccine ( OPV ) . This paper reports results from Belém , Brazil , where the number of subjects per group and the viral vaccine titers were : 194 ( 10(4.7 ) focus forming units - FFU ) , 196 ( 10(5.2 ) FFU ) , 194 ( 10(5.8 ) FFU ) and 194 ( placebo ) . Anti-rotavirus ( anti-RV ) antibody response was assessed in 307 subjects .  Clinical severity of gastroenteritis episodes was measured using a 20-point scoring system with a score of > or= 11 defined as severe GE . RESULTS The rates of solicited general symptoms were similar in vaccine and placebo recipients . At 2 months after the second dose , a serum IgA response to RV occurred in 54.7 to 74.4 % of vaccinees . No interference was seen in the immunogenicity of routine vaccines . Vaccine efficacy against any rotavirus gastroenteritis ( RVGE ) was 63.5 % ( 95%CI 20.8 - 84.4 ) for the highest concentration ( 10(5.8 ) FFU ) . Efficacy was 81.5 % ( 95%CI 44.5 - 95.4 ) against severe RVGE . At its highest concentration ( 10(5.8 ) FFU ) , RIX4414 provided 79.8 % ( 95%CI 26.4 - 96.3 ) protection against severe RVGE by G9 strain . CONCLUSIONS RIX4414 was highly immunogenic with a low reactogenicity profile and did not interfere with seroresponse to diphtheria , tetanus , pertussis , hepatitis B and Hib antigens . Two doses of RIX4414 provided significant protection against severe GE caused by RV BACKGROUND The safety and efficacy of an attenuated G1P[8 ] human rotavirus ( HRV ) vaccine were tested in a r and omized , double-blind , phase 3 trial . METHODS We studied 63,225 healthy infants from 11 Latin American countries and Finl and who received two oral doses of either the HRV vaccine ( 31,673 infants ) or placebo ( 31,552 infants ) at approximately two months and four months of age . Severe gastroenteritis episodes were identified by active surveillance . The severity of disease was grade d with the use of the 20-point Vesikari scale . Vaccine efficacy was evaluated in a subgroup of 20,169 infants ( 10,159 vaccinees and 10,010 placebo recipients ) . RESULTS The efficacy of the vaccine against severe rotavirus gastroenteritis and against rotavirus-associated hospitalization was 85 percent ( P<0.001 for the comparison with placebo ) and reached 100 percent against more severe rotavirus gastroenteritis . Hospitalization for diarrhea of any cause was reduced by 42 percent ( 95 percent confidence interval , 29 to 53 percent ; P<0.001 ) . During the 31-day window after each dose , six vaccine recipients and seven placebo recipients had definite intussusception ( difference in risk , -0.32 per 10,000 infants ; 95 percent confidence interval , -2.91 to 2.18 ; P=0.78 ) . CONCLUSIONS Two oral doses of the live attenuated G1P[8 ] HRV vaccine were highly efficacious in protecting infants against severe rotavirus gastroenteritis , significantly reduced the rate of severe gastroenteritis from any cause , and were not associated with an increased risk of intussusception . ( Clinical Trials.gov numbers , NCT00139347 and NCT00263666 . Background : A live attenuated monovalent rotavirus vaccine RIX4414 was developed with a human strain of G1P1A P[8 ] specificity to reduce the rotavirus burden in children . Methods : A double blind , r and omized , placebo-controlled study evaluated the efficacy , immunogenicity , safety and reactogenicity of 2 oral doses of RIX4414 ( 104.7 , 105.2 or 105.8 focus-forming units ) at 2 and 4 months coadministered with routine vaccinations and oral poliovirus vaccine given for study purpose s at least 14 days apart . The 2155 infants ( 1618 vaccine/537 placebo ) enrolled in Brazil , Mexico and Venezuela were followed until 1 year of age . Results : Antirotavirus IgA seroconversion rates 2 months after dose 2 ranged between 61 % ( 10 4.7 ffu group ) and 65 % ( 105.8 ffu group ) , and most of the infants had seroprotective levels of antibodies to coadministered routine vaccinations . The reactogenicity profile of RIX4414 was similar to that of the placebo , and no vaccination-related serious adverse events were reported . Protective efficacy against severe and any rotavirus gastroenteritis from 15 days post-dose 2 was highest in the 105.8 ffu group [ 86 % ; 95 % confidence interval ( 95 % CI ) , 63–96 % and 70 % ( 95 % CI 46–84 % ) , P < 0.001 , 2-sided Fisher 's exact test ] . The efficacy against hospitalization was 79 % ( 95 % CI 48–92 % ) for pooled vaccine groups . Multiple rotavirus serotypes [ G1 ( 50 % ) , G9 ( 40 % ) , G2 , G3 and G4 ] were identified from gastroenteritis stools ( enzyme-linked immunosorbent assay and reverse transcription-polymerase chain reaction ) during the study period . For severe gastroenteritis caused by G9 serotypes , the protection reached 77 % ( 95 % CI  
    Output:
    