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: Rotavirus ( RV ) infection is the primary cause for childhood gastroenteritis worldwide . In Korea , RV infection is most common among children less than 5 y of age . This post-licensure study was conducted to further evaluate the RV vaccine ( RIX4414 ) to provide additional local clinical data to the Korean Food and Drug Association . Healthy infants aged 6–12 weeks were enrolled to receive two doses of either RIX4414 or placebo as per 0 , 1–2 mo schedule . Blood sample s were collected before dose-1 and one month post-dose-2 of RIX4414/placebo to assess serum anti-RV IgA antibody concentrations using ELISA . Gastroenteritis stool sample s were tested for the presence of RV using ELISA . RV positive sample s were subjected to further analysis for G and P typing . Among 684 infants enrolled and vaccinated , 432 infants ( RIX4414 = 318 ; placebo = 114 ) were included in the according-to- protocol cohort for immunogenicity . The anti-RV IgA antibody seroconversion rates in the RIX4414 group following one month post-dose-2 were 88.1 % ( 95 % CI : 84.0–91.4 ) and the corresponding geometric mean concentration in the RIX4414 group was 208.5 U/ml ( 95 % CI : 174.2–249.5 ) . Occurrence of solicited and unsolicited adverse events were similar in both , RIX4414 and placebo groups . None of the gastroenteritis stool sample s tested positive for RV and no fatal SAEs were reported in either groups . The two-dose regimen of RIX4414 was observed to be immunogenic with a similar safety profile as compared with the placebo group , when administered to healthy Korean infants Groups of 122 Peruvian adults of low socioeconomic level ( SEL ) and 125 of high SEL received a r and omly allocated 5 x 10(9)- or 5 x 10(8)-CFU dose of CVD 103-HgR live oral cholera vaccine or a placebo . The vaccine was well tolerated . Vibriocidal seroconversions occurred in 78 % of high-SEL and 72 % of low-SEL subjects who ingested the high dose and in 78 and 49 % , respectively , of those who received the low dose Co-administration of oral live-attenuated human rotavirus vaccine RIX4414 ( Rotarix ) and oral polio vaccine ( OPV ) was assessed . Healthy infants were r and omised to receive 2-doses of either : RIX4414 or placebo co-administered with OPV ( 12 and 16 weeks of age ) ; or RIX4414 or placebo given 15 days after OPV . After vaccination , 56.5 - 66.7 % of RIX4414 and 18.6 % of placebo recipients had seroconverted for rotavirus IgA. No significant differences between RIX4414 groups with or without OPV co-administration were observed . No statistically significant differences were observed between groups for polio seroprotection rates . RIX4414 vaccine was immunogenic when co-administered with OPV and did not interfere with OPV seroprotection rates 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 . The correlation of antibody responses ( serum rotavirus IgA and neutralizing antibody to serotype G1-G4 human rotaviruses and rhesus rotavirus [ RRV ] ) in a reassortant rotavirus vaccine trial with protection against rotavirus infection or disease was investigated . Most subjects administered 4 x 10(5 ) pfu of either the serotype G1 monovalent or serotype G1-G4 tetravalent vaccine seroconverted for at least one of the six antibodies ( 85 % and 91 % , respectively ) . However , fewer than one-third seroconverted to any prototype G1-G4 human rotavirus . Analyses of covariance indicated that higher prevaccination neutralizing antibody titers negatively affected postvaccination titers . Significant relationships were found between several postvaccination rotavirus antibody titers and protection , and serotype-specific correlates of protection were identified between anti-Wa titers and G1 illnesses ( P = .03 ) and between anti-RRV titers and G3 illnesses ( P < .001 ) . Overall , however , serotype-specific immunity was no more significant than heterotypic immunity , and no specific titer of any antibody analyzed was a reliable indicator of protection A phase III , r and omized , double-blind study evaluated the efficacy , reactogenicity , safety and immunogenicity of a human rotavirus vaccine , RIX4414 in Japanese infants aged 6 - 14 weeks when administered as two doses ( 0 , 1-month schedule ) . Efficacy against any and severe rotavirus gastroenteritis leading to medical intervention caused by circulating wild-type rotavirus from two weeks post-Dose 2 until two years of age was 79.3 % ( 95 % CI : 60.5 - 89.8 % ) and 91.6 % ( 95 % CI : 62.4 - 99.1 % ) , respectively . Solicited , unsolicited symptoms and serious adverse events were reported at a similar frequency in both groups . Serum anti-rotavirus antibody seroconversion rate one-month post-Dose 2 was 85.3 % ( 95 % CI : 68.9 - 95 % ) in RIXX4414 group . RIX4414 was efficacious , well-tolerated and immunogenic in Japanese infants and introduction of vaccination could help in reducing the disease burden Rotavirus gastroenteritis is a major cause of morbidity and mortality among African infants and young children . A phase III , placebo-controlled , multi-centre clinical trial of a live , oral G1P[8 ] human rotavirus vaccine ( RIX4414 ) undertaken in Malawi and South Africa significantly reduced the incidence of severe rotavirus gastroenteritis in the first year of life . We now report on vaccine efficacy in the Malawi cohort of children who were followed into the second year of life . A total of 1773 healthy infants were enrolled in Blantyre , Malawi into three groups . Two groups received three doses of RIX4414 or placebo at age 6 , 10 , and 14 weeks and the third group received placebo at 6 weeks and RIX4414 at age 10 and 14 weeks . Subjects were followed by weekly home visits for episodes of gastroenteritis until 1 year of age , and were then re-consented for further follow-up to 18 - 24 months of age . Severity of gastroenteritis episodes was grade d according to the Vesikari scoring system . Seroconversion for anti-rotavirus IgA was determined on a subset of children by using ELISA on pre- and post-vaccine blood sample s. Rotavirus VP7 ( G ) and VP4 ( P ) genotypes were determined by RT-PCR . A total of 70/1030 ( 6.8 % , 95 % CI 5.3 - 8.5 ) subjects in the pooled ( 2 dose plus 3 dose ) RIX4414 group compared with 53/483 ( 11.0 % , 8.3 - 14.1 ) subjects in the placebo group developed severe rotavirus gastroenteritis in the entire follow-up period ( vaccine efficacy 38.1 % ( 9.8 - 57.3 ) ) . The point estimate of efficacy in the second year of life ( 17.6 % ; -59.2 to 56.0 ) was lower than in the first year of life ( 49.4 % ; 19.2 - 68.3 ) . There were non-significant trends towards a higher efficacy in the second year of life among children who received the three-dose schedule compared with the two-dose schedule , and a higher anti-rotavirus IgA seroresponse rate in the three-dose RIX4414 group . Rotavirus strains detected included genotype G12 ( 31 % ) ; G9 ( 23 % ) ; and G8 ( 18 % ) ; only 18 % of strains belonged to the G1P[8 ] genotype . While the optimal dosing schedule of RIX4414 in African infants requires further investigation , vaccination with RIX4414 significantly reduced the incidence of severe gastroenteritis caused by diverse rotavirus strains in an impoverished African population with high rotavirus disease burden in the first two years of life In a four cell trial , a single 10(4 ) plaque-forming unit dose of rhesus rotavirus ( RRV ) vaccine ( serotype G3 ) , a human rotavirus-rhesus rotavirus reassortant vaccine with serotype G1 specificity , a similar vaccine with serotype G2 specificity , or a placebo was administered with buffer orally at 2 months of age to 800 Peruvian infants . Only the RRV vaccine was associated with a febrile response ( < 38 degrees C ) that occurred in 9 % of the infants on day 4 after vaccination . Diarrhea or other side-effects were not associated with administration of vaccine . Vaccine strains were shed by only 12 - 18 % of the infants as determined by examination of a single stool specimen obtained on days 4 or 5 after vaccination . Fifty per cent of vaccines developed an IgA ELISA seroresponse ; however , a serotype-specific seroresponse by plaque reduction neutralization was demonstrated in < 20 % of the participants against each of the three c and i date vaccine strains . Vaccine efficacy was evaluated by twice-weekly home surveillance for diarrheal diseases during 24 months post-immunization . Rotavirus diarrheal episodes were identified by ELISA . Only the RRV vaccine had a significant protective efficacy ( 29 % , p = 0.03 , chi-square test ) against rotavirus diarrhea . Analysis of vaccine efficacy against rotavirus episodes of any severity in which no other enteropathogen was isolated showed a trend towards higher vaccine efficacy . In addition , a similar trend was observed in rotavirus-only episodes in which there was some degree of dehydration or when health services were utilized . Serotype G1 or G2 rotavirus strains were most prevalent during surveillance . Neither serotype G1 or serotype G2 vaccines were protective against serotype 1 or 2 rotavirus diarrhea , respectively . The serotype G2 vaccine was 84 % protective against serotype 1 and 2 dehydrating rotavirus diarrhea in the small numbers of individuals evaluated . We conclude that one dose of 10(4 ) p.f.u . of the RRV , serotype G1 , or serotype G2 rotavirus vaccine failed to induce either an adequate serotype-specific seroresponse or serotype-specific protection in children immunized at 2 months of age . Only the RRV vaccine induced a low level of protection against rotavirus diarrhea mainly of serotype G1 specificity . Future studies need to explore whether higher vaccine dose and /or more than one dose would increase the immunogenicity and efficacy of the rotavirus vaccine , especially in developing countries with a high level of baseline rotavirus antibodies BACKGROUND We evaluated the immunogenicity of the pentavalent rotavirus 
    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: Rotavirus ( RV ) infection is the primary cause for childhood gastroenteritis worldwide . In Korea , RV infection is most common among children less than 5 y of age . This post-licensure study was conducted to further evaluate the RV vaccine ( RIX4414 ) to provide additional local clinical data to the Korean Food and Drug Association . Healthy infants aged 6–12 weeks were enrolled to receive two doses of either RIX4414 or placebo as per 0 , 1–2 mo schedule . Blood sample s were collected before dose-1 and one month post-dose-2 of RIX4414/placebo to assess serum anti-RV IgA antibody concentrations using ELISA . Gastroenteritis stool sample s were tested for the presence of RV using ELISA . RV positive sample s were subjected to further analysis for G and P typing . Among 684 infants enrolled and vaccinated , 432 infants ( RIX4414 = 318 ; placebo = 114 ) were included in the according-to- protocol cohort for immunogenicity . The anti-RV IgA antibody seroconversion rates in the RIX4414 group following one month post-dose-2 were 88.1 % ( 95 % CI : 84.0–91.4 ) and the corresponding geometric mean concentration in the RIX4414 group was 208.5 U/ml ( 95 % CI : 174.2–249.5 ) . Occurrence of solicited and unsolicited adverse events were similar in both , RIX4414 and placebo groups . None of the gastroenteritis stool sample s tested positive for RV and no fatal SAEs were reported in either groups . The two-dose regimen of RIX4414 was observed to be immunogenic with a similar safety profile as compared with the placebo group , when administered to healthy Korean infants Groups of 122 Peruvian adults of low socioeconomic level ( SEL ) and 125 of high SEL received a r and omly allocated 5 x 10(9)- or 5 x 10(8)-CFU dose of CVD 103-HgR live oral cholera vaccine or a placebo . The vaccine was well tolerated . Vibriocidal seroconversions occurred in 78 % of high-SEL and 72 % of low-SEL subjects who ingested the high dose and in 78 and 49 % , respectively , of those who received the low dose Co-administration of oral live-attenuated human rotavirus vaccine RIX4414 ( Rotarix ) and oral polio vaccine ( OPV ) was assessed . Healthy infants were r and omised to receive 2-doses of either : RIX4414 or placebo co-administered with OPV ( 12 and 16 weeks of age ) ; or RIX4414 or placebo given 15 days after OPV . After vaccination , 56.5 - 66.7 % of RIX4414 and 18.6 % of placebo recipients had seroconverted for rotavirus IgA. No significant differences between RIX4414 groups with or without OPV co-administration were observed . No statistically significant differences were observed between groups for polio seroprotection rates . RIX4414 vaccine was immunogenic when co-administered with OPV and did not interfere with OPV seroprotection rates 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 . The correlation of antibody responses ( serum rotavirus IgA and neutralizing antibody to serotype G1-G4 human rotaviruses and rhesus rotavirus [ RRV ] ) in a reassortant rotavirus vaccine trial with protection against rotavirus infection or disease was investigated . Most subjects administered 4 x 10(5 ) pfu of either the serotype G1 monovalent or serotype G1-G4 tetravalent vaccine seroconverted for at least one of the six antibodies ( 85 % and 91 % , respectively ) . However , fewer than one-third seroconverted to any prototype G1-G4 human rotavirus . Analyses of covariance indicated that higher prevaccination neutralizing antibody titers negatively affected postvaccination titers . Significant relationships were found between several postvaccination rotavirus antibody titers and protection , and serotype-specific correlates of protection were identified between anti-Wa titers and G1 illnesses ( P = .03 ) and between anti-RRV titers and G3 illnesses ( P < .001 ) . Overall , however , serotype-specific immunity was no more significant than heterotypic immunity , and no specific titer of any antibody analyzed was a reliable indicator of protection A phase III , r and omized , double-blind study evaluated the efficacy , reactogenicity , safety and immunogenicity of a human rotavirus vaccine , RIX4414 in Japanese infants aged 6 - 14 weeks when administered as two doses ( 0 , 1-month schedule ) . Efficacy against any and severe rotavirus gastroenteritis leading to medical intervention caused by circulating wild-type rotavirus from two weeks post-Dose 2 until two years of age was 79.3 % ( 95 % CI : 60.5 - 89.8 % ) and 91.6 % ( 95 % CI : 62.4 - 99.1 % ) , respectively . Solicited , unsolicited symptoms and serious adverse events were reported at a similar frequency in both groups . Serum anti-rotavirus antibody seroconversion rate one-month post-Dose 2 was 85.3 % ( 95 % CI : 68.9 - 95 % ) in RIXX4414 group . RIX4414 was efficacious , well-tolerated and immunogenic in Japanese infants and introduction of vaccination could help in reducing the disease burden Rotavirus gastroenteritis is a major cause of morbidity and mortality among African infants and young children . A phase III , placebo-controlled , multi-centre clinical trial of a live , oral G1P[8 ] human rotavirus vaccine ( RIX4414 ) undertaken in Malawi and South Africa significantly reduced the incidence of severe rotavirus gastroenteritis in the first year of life . We now report on vaccine efficacy in the Malawi cohort of children who were followed into the second year of life . A total of 1773 healthy infants were enrolled in Blantyre , Malawi into three groups . Two groups received three doses of RIX4414 or placebo at age 6 , 10 , and 14 weeks and the third group received placebo at 6 weeks and RIX4414 at age 10 and 14 weeks . Subjects were followed by weekly home visits for episodes of gastroenteritis until 1 year of age , and were then re-consented for further follow-up to 18 - 24 months of age . Severity of gastroenteritis episodes was grade d according to the Vesikari scoring system . Seroconversion for anti-rotavirus IgA was determined on a subset of children by using ELISA on pre- and post-vaccine blood sample s. Rotavirus VP7 ( G ) and VP4 ( P ) genotypes were determined by RT-PCR . A total of 70/1030 ( 6.8 % , 95 % CI 5.3 - 8.5 ) subjects in the pooled ( 2 dose plus 3 dose ) RIX4414 group compared with 53/483 ( 11.0 % , 8.3 - 14.1 ) subjects in the placebo group developed severe rotavirus gastroenteritis in the entire follow-up period ( vaccine efficacy 38.1 % ( 9.8 - 57.3 ) ) . The point estimate of efficacy in the second year of life ( 17.6 % ; -59.2 to 56.0 ) was lower than in the first year of life ( 49.4 % ; 19.2 - 68.3 ) . There were non-significant trends towards a higher efficacy in the second year of life among children who received the three-dose schedule compared with the two-dose schedule , and a higher anti-rotavirus IgA seroresponse rate in the three-dose RIX4414 group . Rotavirus strains detected included genotype G12 ( 31 % ) ; G9 ( 23 % ) ; and G8 ( 18 % ) ; only 18 % of strains belonged to the G1P[8 ] genotype . While the optimal dosing schedule of RIX4414 in African infants requires further investigation , vaccination with RIX4414 significantly reduced the incidence of severe gastroenteritis caused by diverse rotavirus strains in an impoverished African population with high rotavirus disease burden in the first two years of life In a four cell trial , a single 10(4 ) plaque-forming unit dose of rhesus rotavirus ( RRV ) vaccine ( serotype G3 ) , a human rotavirus-rhesus rotavirus reassortant vaccine with serotype G1 specificity , a similar vaccine with serotype G2 specificity , or a placebo was administered with buffer orally at 2 months of age to 800 Peruvian infants . Only the RRV vaccine was associated with a febrile response ( < 38 degrees C ) that occurred in 9 % of the infants on day 4 after vaccination . Diarrhea or other side-effects were not associated with administration of vaccine . Vaccine strains were shed by only 12 - 18 % of the infants as determined by examination of a single stool specimen obtained on days 4 or 5 after vaccination . Fifty per cent of vaccines developed an IgA ELISA seroresponse ; however , a serotype-specific seroresponse by plaque reduction neutralization was demonstrated in < 20 % of the participants against each of the three c and i date vaccine strains . Vaccine efficacy was evaluated by twice-weekly home surveillance for diarrheal diseases during 24 months post-immunization . Rotavirus diarrheal episodes were identified by ELISA . Only the RRV vaccine had a significant protective efficacy ( 29 % , p = 0.03 , chi-square test ) against rotavirus diarrhea . Analysis of vaccine efficacy against rotavirus episodes of any severity in which no other enteropathogen was isolated showed a trend towards higher vaccine efficacy . In addition , a similar trend was observed in rotavirus-only episodes in which there was some degree of dehydration or when health services were utilized . Serotype G1 or G2 rotavirus strains were most prevalent during surveillance . Neither serotype G1 or serotype G2 vaccines were protective against serotype 1 or 2 rotavirus diarrhea , respectively . The serotype G2 vaccine was 84 % protective against serotype 1 and 2 dehydrating rotavirus diarrhea in the small numbers of individuals evaluated . We conclude that one dose of 10(4 ) p.f.u . of the RRV , serotype G1 , or serotype G2 rotavirus vaccine failed to induce either an adequate serotype-specific seroresponse or serotype-specific protection in children immunized at 2 months of age . Only the RRV vaccine induced a low level of protection against rotavirus diarrhea mainly of serotype G1 specificity . Future studies need to explore whether higher vaccine dose and /or more than one dose would increase the immunogenicity and efficacy of the rotavirus vaccine , especially in developing countries with a high level of baseline rotavirus antibodies BACKGROUND We evaluated the immunogenicity of the pentavalent rotavirus 
    Output:
    