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 : The recommended vaccination schedule for the pneumococcal conjugate vaccine ( PCV ) includes 4 immunizations , according to the national programs in the United States and some European countries . Other countries use a national schedule for routine vaccinations in early childhood that includes only 3 doses . Aims : The goals were to assess the immunogenicity and tolerability of PCV with a vaccination schedule that included 3 doses during the first 1 year of life ( a 2 + 1 dose schedule ) and to determine the immune responses to concomitantly administered Haemophilus influenzae type b ( Hib ) vaccine . Methods : A total of 101 healthy Swedish infants were enrolled in an open , nonr and omized , multicenter study . PCV was administered concomitantly with ( at separate sites ) a diphtheria-tetanus toxoids-acellular pertussis vaccine , inactivated polio vaccine and Hib conjugate vaccine combination at 3 , 5 and 12 months of age . IgG antibody concentrations for the 7 serotypes included in the PCV and the Hib capsular polysaccharide in serum sample s taken at 3 , 6 , 12 and 13 months were determined with enzyme immunoassays . Local and systemic reactions were monitored for 3 days after each immunization , and serious adverse reactions were monitored for the whole study period . Results : Two doses of PCV induced satisfactory antibody responses , with the exception of serotypes 6B and 23F . The third dose evoked strong responses for all serotypes , which suggests good immunologic priming with the primary series of 2 doses . The mean anti-Hib antibody concentrations were similar to those noted in earlier studies among Swedish children . The PCV was well tolerated . Conclusion : The pneumococcal antibody concentrations at 13 months were comparable with those noted previously with the 4-dose schedule . The results suggest that the implementation of a 2 + 1 dose schedule for PCV should be considered The safety , immunogenicity , and impact on carriage of a nonvalent pneumococcal vaccine given at ages 6 , 10 , and 14 weeks were examined in a double-blind , r and omized , placebo-controlled trial in 500 infants in Soweto , South Africa . No serious local or systemic side effects were recorded . Significant antibody responses to all pneumococcal serotypes were observed 4 weeks after the third dose . Haemophilus influenzae type b polyribosylribitol phosphate ( geometric mean titer , 11.62 microg/mL ) and diphtheria ( 1.39 IU/mL ) antibodies were significantly higher in children receiving pneumococcal conjugate , compared with placebo recipients ( 4.58 microgram/mL and 0.98 IU/mL , respectively ) . Nasopharyngeal carriage of vaccine serotypes decreased in vaccinees at age 9 months ( 18 % vs. 36 % ) , whereas carriage of nonvaccine serotypes increased ( 36 % vs. 25 % ) . Carriage of penicillin-resistant pneumococci ( 21 % vs. 41 % ) and cotrimoxazole-resistant pneumococci ( 23 % vs. 35 % ) were significantly reduced 9 months after vaccination , compared with controls Background . Development of protein-conjugated pneumococcal vaccines for infants has led to formulations that are immunogenic in the age group at highest risk for pneumococcal diseases . This study focuses on the search for an optimal formulation . Methods . In a r and omized trial Icel and ic infants ( n = 160 ) were immunized at age 3 , 4 and 6 months with one of two octavalent pneumococcal conjugate vaccines ( serotypes 3 , 4 , 6B , 9V , 14 , 18C , 19F and 23F conjugated to diphtheria toxoid ( PncD ) or tetanus protein ( PncT ) followed with a booster of either the same conjugate or 23-valent polysaccharide vaccine at 13 months . Safety data were collected after each vaccination , and IgG responses ( enzyme-linked immunosorbent assay ) were measured at 3 , 4 , 6 , 7 , 13 and 14 months . Results . Both conjugates were safe and caused fewer local reactions than the routine vaccines ( P < 0.0001 ) . At 7 months both groups had significant IgG response to all serotypes . The geometric mean concentration range was 0.35 to 4.09 and 0.65 to 3.38 & mgr;g/ml for PncD and PncT , respectively , with 88.2 to 100 % and 92.4 to 100 % of subjects reaching ≥0.15 & mgr;g/ml . The PncD gave better primary responses to serotypes 3 , 9V and 18C , whereas PncT gave better response to serotype 4 . Similar responses were induced to the other serotypes . Good booster IgG responses were obtained in all vaccine groups ; 97.5 to 100 % of subjects reached ≥1 & mgr;g/ml . Conclusions . Both octavalent pneumococcal conjugates were safe and immunogenic in infants . Based on the results from this and similar trials , a mixed diphtheria and tetanus pneumococcal conjugate vaccine was design ed to provide the optimal immune response to each serotype Background : The 7-valent pneumococcal ( 7vPn ) conjugate vaccine is licensed for primary and booster vaccination according to the same immunization schedules as routinely recommended diphtheria-tetanus-pertussis-based childhood vaccines and can be coadministered during the same vaccination visit . Methods : An open , r and omized study evaluated the immunogenicity and safety of a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio virus-Haemophilus influenzae type b ( DTPa-HBV-IPV/Hib ) vaccine and a 7vPn conjugate vaccine when coadministered at 2 , 3 and 4 months and 12–23 months of age , compared with the administration of the hexavalent DTPa-HBV-IPV/Hib vaccine given alone . Serum antibody titers were measured before and 1 month after the primary course and before and 1 month after the booster dose . Solicited local and general adverse events were recorded for 4 days and unsolicited adverse events were recorded for 30 days after each vaccine dose . Results : A total of 345 subjects were enrolled for primary vaccination with the hexavalent vaccine  ( 170 without and 175 with the  7vPn vaccine coadministered ) and 266 returned for booster vaccination ( 122 without and 144 with coadministration of the 7vPn vaccine ) . After primary vaccination , antibody responses against the common antigens were similar in both groups , with seroprotection rates of 93.6–100 % and with similar antibody decay before booster vaccination . The fourth dose induced a vigorous booster response , with seroprotection/vaccine response rates of 96.8–100 % . Response to the 7vPn primary and booster vaccination was within previously reported ranges . Differences in reactogenicity result ed from higher incidences of symptoms after concomitant vaccination . Rectal temperature > 39.5 ° C was observed after 1.2 % of the coadministered vaccine doses during primary vaccination and after 2.8 % of the booster vaccine doses . Conclusion : Coadministration of the DTPa-HBV-IPV/Hib and 7vPn vaccines at separate injection sites during the same vaccination visit was effective and safe BACKGROUND Pneumonia is estimated to cause 2 million deaths every year in children . Streptococcus pneumoniae is the most important cause of severe pneumonia . We aim ed to assess the efficacy of a nine-valent pneumococcal conjugate vaccine in children . METHODS We undertook a r and omised , placebo-controlled , double-blind trial in eastern Gambia . Children age 6 - 51 weeks were r and omly allocated three doses of either pneumococcal conjugate vaccine ( n=8718 ) or placebo ( 8719 ) , with intervals of at least 25 days between doses . Our primary outcome was first episode of radiological pneumonia . Secondary endpoints were clinical or severe clinical pneumonia , invasive pneumococcal disease , and all-cause admissions . Analyses were per protocol and intention to treat . FINDINGS 529 children assigned vaccine and 568 allocated  placebo were not included in the per- protocol analysis . Results of per- protocol and intention-to-treat analyses were similar . By per- protocol analysis , 333 of 8189 children given vaccine had an episode of radiological pneumonia compared with 513 of 8151 who received placebo . Pneumococcal vaccine efficacy was 37 % ( 95 % CI 27 - 45 ) against first episode of radiological pneumonia . First episodes of clinical pneumonia were reduced overall by 7 % ( 95 % CI 1 - 12 ) . Efficacy of the conjugate vaccine was 77 % ( 51 - 90 ) against invasive pneumococcal disease caused by vaccine serotypes , 50 % ( 21 - 69 ) against disease caused by all serotypes , and 15 % ( 7 - 21 ) against all-cause admissions . We also found an efficacy of 16 % ( 3 - 28 ) against mortality . 110 serious adverse events arose in children given the pneumococcal vaccine compared with 131 in those who received placebo . INTERPRETATION In this rural African setting , pneumococcal conjugate vaccine has high efficacy against radiological pneumonia and invasive pneumococcal disease , and can substantially reduce admissions and improve child survival . Pneumococcal conjugate vaccines should be made available to African infants Background An 11-valent pneumococcal conjugate vaccine could provide significantly larger reduction in pneumococcal disease burden than the currently available 7-valent vaccine formulation in many countries . Methods In total , 50 infants were enrolled to this open , uncontrolled study , which evaluated the safety and immunogenicity of an aluminium adjuvanted 11-valent mixed-carrier diphtheria toxoid or tetanus protein-conjugated vaccine ( 11-PncTD ) when administered in three doses at 6 , 10 and 14 weeks of age simultaneously with DTwP//PRP-T and OPV vaccines in Filipino infants . Results The rates of local reactions between the two injection sites , those associated with the 11-PncTD vaccine and those with the DTwP//PRP-T were almost of equal frequency for all three vaccine doses except for in duration , which was significantly more common in the DTP//PRP-T injection site . Fever was present in 39 % , 22 % and 21 % of infants following each of the three doses . Antibody responses were determined by an enzyme immunoassay method before the first vaccination and after the three doses . The vaccine elicited a significant anti-pneumococcal polysaccharide antibody response against all serotypes included in the vaccine , except for type 14 , for which the pre-vaccination geometric mean antibody concentration ( GMC ) was high ( 1.61 μg/ml ) . The GMCs one month after the vaccination series ranged from 1.1 micrograms/ml for type 6B to 23.4 μg/ml for type 4 . Conclusion The 11-PncTD vaccine is safe , well-tolerated and immunogenic . The effectiveness of the non-adjuvanted formulation of the vaccine in preventing pneumonia is currently being evaluated in the Philippines UNLABELLED This study evaluates the safety and immunogenicity of pneumococcal seven-valent conjugate vaccine ( Prevenar ) in 115 children , aged 2 - 3 years ( 24 - 36 months ) , who have not been previously vaccinated with Prevenar .  RESULTS SAFETY As for local reactions , 40 % of children reported erythema , 32.2 % in duration and 39.1 % tenderness at the injection site . Regarding systemic reactions , fever > or 38 C was recorded in 7 % of patients . Other commonly reported events were decreased appetite ( 24.3 % ) , restlessness ( 20 % ) , and fussiness ( 18.3 % ) . IMMUNOGENICITY After vaccination , more than 98 % of the subjects achieved antibody levels of > or = 0.15 microg/mL for all seven serotypes and more than 95 % achieved antibody levels > or = 0.50 microg/mL for all serotypes . CONCLUSIONS Pneumococcal seven-valent conjugate vaccine ( Prevenar ) was safe , well tolerated and highly immunogenic when administered in previously unvaccinated children aged 14 - 36 months BACKGROUND Streptococcus pneumoniae is a major disease burden in young children and the incidence of antibiotic-resistant pneumococcal strains is increasing . Multivalent pneumococcal saccharide-protein conjugate vaccines have 
    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 : The recommended vaccination schedule for the pneumococcal conjugate vaccine ( PCV ) includes 4 immunizations , according to the national programs in the United States and some European countries . Other countries use a national schedule for routine vaccinations in early childhood that includes only 3 doses . Aims : The goals were to assess the immunogenicity and tolerability of PCV with a vaccination schedule that included 3 doses during the first 1 year of life ( a 2 + 1 dose schedule ) and to determine the immune responses to concomitantly administered Haemophilus influenzae type b ( Hib ) vaccine . Methods : A total of 101 healthy Swedish infants were enrolled in an open , nonr and omized , multicenter study . PCV was administered concomitantly with ( at separate sites ) a diphtheria-tetanus toxoids-acellular pertussis vaccine , inactivated polio vaccine and Hib conjugate vaccine combination at 3 , 5 and 12 months of age . IgG antibody concentrations for the 7 serotypes included in the PCV and the Hib capsular polysaccharide in serum sample s taken at 3 , 6 , 12 and 13 months were determined with enzyme immunoassays . Local and systemic reactions were monitored for 3 days after each immunization , and serious adverse reactions were monitored for the whole study period . Results : Two doses of PCV induced satisfactory antibody responses , with the exception of serotypes 6B and 23F . The third dose evoked strong responses for all serotypes , which suggests good immunologic priming with the primary series of 2 doses . The mean anti-Hib antibody concentrations were similar to those noted in earlier studies among Swedish children . The PCV was well tolerated . Conclusion : The pneumococcal antibody concentrations at 13 months were comparable with those noted previously with the 4-dose schedule . The results suggest that the implementation of a 2 + 1 dose schedule for PCV should be considered The safety , immunogenicity , and impact on carriage of a nonvalent pneumococcal vaccine given at ages 6 , 10 , and 14 weeks were examined in a double-blind , r and omized , placebo-controlled trial in 500 infants in Soweto , South Africa . No serious local or systemic side effects were recorded . Significant antibody responses to all pneumococcal serotypes were observed 4 weeks after the third dose . Haemophilus influenzae type b polyribosylribitol phosphate ( geometric mean titer , 11.62 microg/mL ) and diphtheria ( 1.39 IU/mL ) antibodies were significantly higher in children receiving pneumococcal conjugate , compared with placebo recipients ( 4.58 microgram/mL and 0.98 IU/mL , respectively ) . Nasopharyngeal carriage of vaccine serotypes decreased in vaccinees at age 9 months ( 18 % vs. 36 % ) , whereas carriage of nonvaccine serotypes increased ( 36 % vs. 25 % ) . Carriage of penicillin-resistant pneumococci ( 21 % vs. 41 % ) and cotrimoxazole-resistant pneumococci ( 23 % vs. 35 % ) were significantly reduced 9 months after vaccination , compared with controls Background . Development of protein-conjugated pneumococcal vaccines for infants has led to formulations that are immunogenic in the age group at highest risk for pneumococcal diseases . This study focuses on the search for an optimal formulation . Methods . In a r and omized trial Icel and ic infants ( n = 160 ) were immunized at age 3 , 4 and 6 months with one of two octavalent pneumococcal conjugate vaccines ( serotypes 3 , 4 , 6B , 9V , 14 , 18C , 19F and 23F conjugated to diphtheria toxoid ( PncD ) or tetanus protein ( PncT ) followed with a booster of either the same conjugate or 23-valent polysaccharide vaccine at 13 months . Safety data were collected after each vaccination , and IgG responses ( enzyme-linked immunosorbent assay ) were measured at 3 , 4 , 6 , 7 , 13 and 14 months . Results . Both conjugates were safe and caused fewer local reactions than the routine vaccines ( P < 0.0001 ) . At 7 months both groups had significant IgG response to all serotypes . The geometric mean concentration range was 0.35 to 4.09 and 0.65 to 3.38 & mgr;g/ml for PncD and PncT , respectively , with 88.2 to 100 % and 92.4 to 100 % of subjects reaching ≥0.15 & mgr;g/ml . The PncD gave better primary responses to serotypes 3 , 9V and 18C , whereas PncT gave better response to serotype 4 . Similar responses were induced to the other serotypes . Good booster IgG responses were obtained in all vaccine groups ; 97.5 to 100 % of subjects reached ≥1 & mgr;g/ml . Conclusions . Both octavalent pneumococcal conjugates were safe and immunogenic in infants . Based on the results from this and similar trials , a mixed diphtheria and tetanus pneumococcal conjugate vaccine was design ed to provide the optimal immune response to each serotype Background : The 7-valent pneumococcal ( 7vPn ) conjugate vaccine is licensed for primary and booster vaccination according to the same immunization schedules as routinely recommended diphtheria-tetanus-pertussis-based childhood vaccines and can be coadministered during the same vaccination visit . Methods : An open , r and omized study evaluated the immunogenicity and safety of a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio virus-Haemophilus influenzae type b ( DTPa-HBV-IPV/Hib ) vaccine and a 7vPn conjugate vaccine when coadministered at 2 , 3 and 4 months and 12–23 months of age , compared with the administration of the hexavalent DTPa-HBV-IPV/Hib vaccine given alone . Serum antibody titers were measured before and 1 month after the primary course and before and 1 month after the booster dose . Solicited local and general adverse events were recorded for 4 days and unsolicited adverse events were recorded for 30 days after each vaccine dose . Results : A total of 345 subjects were enrolled for primary vaccination with the hexavalent vaccine  ( 170 without and 175 with the  7vPn vaccine coadministered ) and 266 returned for booster vaccination ( 122 without and 144 with coadministration of the 7vPn vaccine ) . After primary vaccination , antibody responses against the common antigens were similar in both groups , with seroprotection rates of 93.6–100 % and with similar antibody decay before booster vaccination . The fourth dose induced a vigorous booster response , with seroprotection/vaccine response rates of 96.8–100 % . Response to the 7vPn primary and booster vaccination was within previously reported ranges . Differences in reactogenicity result ed from higher incidences of symptoms after concomitant vaccination . Rectal temperature > 39.5 ° C was observed after 1.2 % of the coadministered vaccine doses during primary vaccination and after 2.8 % of the booster vaccine doses . Conclusion : Coadministration of the DTPa-HBV-IPV/Hib and 7vPn vaccines at separate injection sites during the same vaccination visit was effective and safe BACKGROUND Pneumonia is estimated to cause 2 million deaths every year in children . Streptococcus pneumoniae is the most important cause of severe pneumonia . We aim ed to assess the efficacy of a nine-valent pneumococcal conjugate vaccine in children . METHODS We undertook a r and omised , placebo-controlled , double-blind trial in eastern Gambia . Children age 6 - 51 weeks were r and omly allocated three doses of either pneumococcal conjugate vaccine ( n=8718 ) or placebo ( 8719 ) , with intervals of at least 25 days between doses . Our primary outcome was first episode of radiological pneumonia . Secondary endpoints were clinical or severe clinical pneumonia , invasive pneumococcal disease , and all-cause admissions . Analyses were per protocol and intention to treat . FINDINGS 529 children assigned vaccine and 568 allocated  placebo were not included in the per- protocol analysis . Results of per- protocol and intention-to-treat analyses were similar . By per- protocol analysis , 333 of 8189 children given vaccine had an episode of radiological pneumonia compared with 513 of 8151 who received placebo . Pneumococcal vaccine efficacy was 37 % ( 95 % CI 27 - 45 ) against first episode of radiological pneumonia . First episodes of clinical pneumonia were reduced overall by 7 % ( 95 % CI 1 - 12 ) . Efficacy of the conjugate vaccine was 77 % ( 51 - 90 ) against invasive pneumococcal disease caused by vaccine serotypes , 50 % ( 21 - 69 ) against disease caused by all serotypes , and 15 % ( 7 - 21 ) against all-cause admissions . We also found an efficacy of 16 % ( 3 - 28 ) against mortality . 110 serious adverse events arose in children given the pneumococcal vaccine compared with 131 in those who received placebo . INTERPRETATION In this rural African setting , pneumococcal conjugate vaccine has high efficacy against radiological pneumonia and invasive pneumococcal disease , and can substantially reduce admissions and improve child survival . Pneumococcal conjugate vaccines should be made available to African infants Background An 11-valent pneumococcal conjugate vaccine could provide significantly larger reduction in pneumococcal disease burden than the currently available 7-valent vaccine formulation in many countries . Methods In total , 50 infants were enrolled to this open , uncontrolled study , which evaluated the safety and immunogenicity of an aluminium adjuvanted 11-valent mixed-carrier diphtheria toxoid or tetanus protein-conjugated vaccine ( 11-PncTD ) when administered in three doses at 6 , 10 and 14 weeks of age simultaneously with DTwP//PRP-T and OPV vaccines in Filipino infants . Results The rates of local reactions between the two injection sites , those associated with the 11-PncTD vaccine and those with the DTwP//PRP-T were almost of equal frequency for all three vaccine doses except for in duration , which was significantly more common in the DTP//PRP-T injection site . Fever was present in 39 % , 22 % and 21 % of infants following each of the three doses . Antibody responses were determined by an enzyme immunoassay method before the first vaccination and after the three doses . The vaccine elicited a significant anti-pneumococcal polysaccharide antibody response against all serotypes included in the vaccine , except for type 14 , for which the pre-vaccination geometric mean antibody concentration ( GMC ) was high ( 1.61 μg/ml ) . The GMCs one month after the vaccination series ranged from 1.1 micrograms/ml for type 6B to 23.4 μg/ml for type 4 . Conclusion The 11-PncTD vaccine is safe , well-tolerated and immunogenic . The effectiveness of the non-adjuvanted formulation of the vaccine in preventing pneumonia is currently being evaluated in the Philippines UNLABELLED This study evaluates the safety and immunogenicity of pneumococcal seven-valent conjugate vaccine ( Prevenar ) in 115 children , aged 2 - 3 years ( 24 - 36 months ) , who have not been previously vaccinated with Prevenar .  RESULTS SAFETY As for local reactions , 40 % of children reported erythema , 32.2 % in duration and 39.1 % tenderness at the injection site . Regarding systemic reactions , fever > or 38 C was recorded in 7 % of patients . Other commonly reported events were decreased appetite ( 24.3 % ) , restlessness ( 20 % ) , and fussiness ( 18.3 % ) . IMMUNOGENICITY After vaccination , more than 98 % of the subjects achieved antibody levels of > or = 0.15 microg/mL for all seven serotypes and more than 95 % achieved antibody levels > or = 0.50 microg/mL for all serotypes . CONCLUSIONS Pneumococcal seven-valent conjugate vaccine ( Prevenar ) was safe , well tolerated and highly immunogenic when administered in previously unvaccinated children aged 14 - 36 months BACKGROUND Streptococcus pneumoniae is a major disease burden in young children and the incidence of antibiotic-resistant pneumococcal strains is increasing . Multivalent pneumococcal saccharide-protein conjugate vaccines have 
    Output:
    