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: INTRODUCTION Children in Singapore receive vaccination against  hepatitis B virus ( HBV ) at 0 , 1 and 5 or 6 months of age , and vaccination against pertussis , diphtheria , tetanus , and polio at 3 , 4 and 5 months of age . Parents often choose to vaccinate with the combined acellular-pertussis-inactivated polio-Hib vaccine ( DTPa-IPV/Hib ) . We investigated whether a combined hexavalent vaccine , DTPa-HBV-IPV/Hib , could replace the separate administration of DTPa-IPV/Hib and HBV for the final vaccination at 5 months of age ( Trial DTPa-HBV-IPV-075 ) . MATERIAL S AND METHODS In an open study , 150 children were r and omised to complete their vaccination schedule with DTPa-IPV/Hib + HBV or DTPa-HBV-IPV/Hib . RESULTS One month after the final vaccination , there was no difference between groups in seroprotection rates or antibody concentrations against HBV . Seroprotection rates against diphtheria , tetanus , Hib and polio , as well as vaccine response rates to pertussis antigens were also similar between groups . Local and general symptoms occurred at a similar rate after the third dose of either vaccine . CONCLUSION The immunogenicity and reactogenicity of the hexavalent vaccine DTPa-HBV-IPV/Hib ( Infanrix hexa , GSK ) group is comparable to that of separately administered DTPa-IPV/Hib and HBV vaccines . Combined hexavalent vaccine , DTPa-HBV-IPV/Hib , could replace the separate administration of DTPa-IPV/Hib and HBV for vaccination at 5 months of age , thereby reducing the number of injections required Background and Aims : Assessment of a new , fully liquid , investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine ( Hexaxim , Sanofi Pasteur ) , containing the same active ingredients as Pentaxim ( DTaP-IPV//PRT-T ) and 10 & mgr;g Hansenula polymorpha-derived recombinant hepatitis B ( Hep B ) surface antigen , Sanofi Pasteur , in Argentinean infants . Methods : Infants born to Hep B surface antigen seronegative mothers were r and omized to receive the DTaP-IPV-Hep B-PRP-T vaccine or Pentaxim and Engerix B Pediatrico ( Hep B monovalent ) vaccines at 2 , 4 , 6 months of age . Antibody titers were measured before and 1 month after 3-month primary vaccination . Noninferiority analyses were performed on seroprotection/seroconversion rates . Safety was evaluated descriptively up to 1 month after primary vaccination . Results : A total of 624 participants were enrolled , 312 participants were r and omized to each group , and 604 participants completed the trial . The DTaP-IPV-Hep B-PRP-T vaccine was demonstrated as noninferior to the Pentaxim and Hep B monovalent vaccines with seroprotection/seroconversion rates 1 month postdose 3 for each valence . The anti-Hep B geometric mean titer 1-month postdose 3 for the investigational DTaP-IPV-Hep B-PRP-T primary series was similar to the monovalent Hep B control . The overall incidence of adverse events was similar among the 2 groups . Conclusions : The new , fully liquid , investigational DTaP-IPV-Hep B-PRP-T vaccine ( Hexaxim ) is highly immunogenic and safe when compared with licensed comparators , warranting further development Antibody avidity to Haemophilus influenzae type b ( Hib ) polysaccharide ( PS ) was assessed in infants vaccinated with diphtheria-tetanus-acellular pertussis ( DTaP ) combined with Hib-PS conjugated to tetanus toxoid ( PRP-T ) and hepatitis B ( HB ) ( DTaP-PRP-T-HB )  and after  a PRP-conjugate ( CRM197-OS ) booster 3 - 7 months later . Avidity differed between infants with anti-Hib-PS IgG antibody < 1 or > 1 microg/mL post primary series ( avidity index [ AI ] , 42 % , 95 % confidence interval [ CI ] , 35%-49 % , and 68 % and 63%-72 % , respectively ; P<.0001 ) . For infants with < 1 microgram/mL anti-Hib-PS IgG antibody , mean AI rose by the time of preboost immunization to 61 % ( 95 % CI , 57%-65 % ) , even though total IgG antibody levels fell . Spontaneous Hib-PS antibody rises after primary series DTaP-PRP-T-HB vaccination were followed by high postboost anti-Hib-PS IgG antibody levels and avidity . The DTaP-PRP-T-HB combination vaccine studied elicits high avidity antibody , and affinity maturation appears to occur in the absence of further antigen exposure even in those with very low anti-Hib-PS antibody Abstract Objectives : The aim of this open , r and omised , multicentre trial was to evaluate the immunogenicity and reactogenicity of the tetravalent diphtheria-tetanus-acellular pertussis-hepatitis B ( DTaP-HBV ) vaccine when given either as a mixed or as a separate concomitant injection with the Haemophilus influenzae type b ( Hib ) vaccine  at 3 , 5 and 11 months of age . Methods : Antibody against diphtheria , tetanus , pertussis ( ELISA ) , hepatitis B ( radioimmunoassay ) and Hib polyribosylribitol phosphate ( PRP ) [ radiolabeled antigen binding assay ] was determined . Solicited local and systemic adverse events were evaluated on the day of each vaccination and for three subsequent days . Follow-up of unsolicited and serious adverse events was conducted for 30 days following each vaccination . Results : A total of 360 subjects were enrolled in the study . After completion of the three-dose vaccination course , seroprotective antibody concentrations against diphtheria , tetanus and hepatitis B , together with a pertussis vaccine response , were seen in almost all subjects with immunogenicity results ( n = 336 ) . All subjects had post-vaccination Hib anti-PRP antibody concentrations of at least 0.15 μg/mL , and 97.0 % and 99.4 % , respectively , of the subjects receiving a single or separate injections had Hib anti-PRP antibody concentrations ≥1.0 μg/mL. Addition of the Hib vaccine to the tetravalent DTaP-HBV vaccine did not increase the incidence of local or systemic reactions . Conclusions : Combination of DTaP-HBV and Hib vaccines in a single injection is safe , immunogenic and well tolerated , and thus has the potential to simplify the childhood immunisation schedule in Italy OBJECTIVES To evaluate the immunogenicity and reactogenicity of a pentavalent vaccine prepared by extemporaneously mixing diphtheria-tetanus pertussis-hepatitis B vaccine ( DTP-HBV ) and lyophilised Haemophilus influenzae type B (Hib)-tetanus conjugate vaccines in the same syringe , compared with the same vaccines given as separate , concomitant administrations . DESIGN Open , r and omised comparative study . SETTING Durban , South Africa . SUBJECTS A total of 120 healthy male and female infants were enrolled in the trial and r and omised into two groups ; group 1 received the combined administration ( DTP-HBV-Hib ) , and group 2 received separate administrations of DTP-HBV and Hib vaccines . Vaccines were given as a three-dose primary vaccination course at 2 , 4 and 6 months [ corrected ] of age . OUTCOME MEASURES Antibody levels were measured using st and ard techniques and local and general solicited symptoms were recorded using diary cards . RESULTS All subjects had seroprotective titres against diphtheria and tetanus ; and antipolyribose-ribitol phosphate ( PRP ) titres > or = 0.15 microgram/ml 1 month after the final dose . A vaccine response ( defined as post-vaccination titres > or = 15 ELISA (EL).U/ml in initially seronegative subjects ; and as post-vaccination titres > or = pre-vaccination titres in initially seropositive subjects ) against the pertussis component was seen in 83 % and 85 % of subjects in the groups receiving combined and separate administration . No differences were seen in any of the geometric mean titres ( GMTs ) between the two administrations either 2 months after the second dose or 1 month after the final dose . There was no observed increase in reactogenicity in the group receiving the mixed administration . CONCLUSIONS The results demonstrate that combined DTP-HBV-Hib vaccine is well tolerated and immunogenic OBJECTIVES In this open-label , non-r and omized phase II study , the safety and immunogenicity of a fully liquid diphtheria-tetanus-whole cell pertussis-hepatitis B-Haemophilus influenzae type b ( DTPw-HepB-Hib ) combination vaccine ( Quinvaxem ( ® ) ) were assessed in infants who had or had not received a birth dose of hepatitis B ( HepB ) vaccine . STUDY DESIGN Two groups of infants , ' HepB at birth ' ( n=110 ) and ' no HepB at birth ' ( n=108 ) , were enrolled and received a primary vaccination course using a 2 - 4 - 6 months schedule . RESULTS Seroprotection/seroconversion rates of > 95 % were achieved against all antigens included in the combination vaccine for both study groups . Although significantly higher anti-hepatitis B virus ( p<0.001 ) and anti-tetanus ( p=0.031 ) antibody titers were achieved in group ' HepB at birth ' when compared with group ' no HepB at birth ' , the proportion of ' no HepB at birth ' subjects achieving protective titers was non-inferior to the proportion of subjects in group ' HepB at birth ' . The birth dose of HepB vaccine did not seem to influence the safety pattern of the DTPw-HepB-Hib combination vaccine . CONCLUSIONS The present study demonstrated that the fully liquid DTPw-HepB-Hib vaccine  was safe and immunogenic when administered using a 2 - 4 - 6 months immunization schedule , regardless of whether or not infants had received a dose of HepB vaccine at birth Abstract The lack of an adequate immune response to the major polysaccharide of the Haemophilus influenzae type b ( Hib ) capsule ( polyribosyl ribitol phosphate ) ( PRP ) in very young infants ( < 18 months ) can be overcome by conjugating PRP to a T-cell dependent carrier protein . We studied whether administration of a tetanus-PRP conjugate vaccine reconstituted with a diphtheria-tetanus-acellular pertussis-hepatitis B ( DTPa-HBV ) vaccine as a three dose primary course at 3 , 4 and 5 months of age induced PRP-specific immunological memory , by examining the anti-PRP response to a dose of unconjugated PRP given with the DTPa-HBV booster approximately 1 year later . The unconjugated PRP elicited protective anti-PRP antibody levels ( ≥ 0.15 μg/ml ) in all but 3 of the 369 vaccinees , including 13 infants who failed to demonstrate a measurable immune response after the primary course . In a sub-cohort of 54 subjects all  had anti-PRP levels  ≥ 0.5 μg/ml within 7–14 days of the booster showing a rapid anamnestic type response . Both primary and booster responses were predominantly IgG1 indicating a T-cell dependent response . The DTPa-HBV components elicited protective anti-diphtheria , anti-tetanus and anti-HBs antibody levels in ≥ 98.5 % of vaccinees , and immune responses to each of the acellular pertussis vaccine components in 92.3%–97.3 % of subjects . Conclusion The tetanus-PRP conjugate vaccine not only elicited a good primary humoral response , but also induced immunological memory so that the infants were able to mount a large and rapid immune response to subsequent exposure to plain PRP , indicating that protection against circulating wild-type Hib had been generated . Successful induction of immunological memory occurred even when there was no measurable humoral anti-PRP response to the primary course . Tetanus-PRP conjugate vaccine can be used in combination with DTPa-HBV vaccine , when administered separately or as a single injection in the same syringe , in primary immunisation schedules at 3 , 4 and 5 months of age OBJECTIVES In 1998 the World Health Organization ( WHO ) recommended the inclusion of Haemophilus influenza type B ( Hib ) conjugate vaccines in infant immunization programs , whenever in 
    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: INTRODUCTION Children in Singapore receive vaccination against  hepatitis B virus ( HBV ) at 0 , 1 and 5 or 6 months of age , and vaccination against pertussis , diphtheria , tetanus , and polio at 3 , 4 and 5 months of age . Parents often choose to vaccinate with the combined acellular-pertussis-inactivated polio-Hib vaccine ( DTPa-IPV/Hib ) . We investigated whether a combined hexavalent vaccine , DTPa-HBV-IPV/Hib , could replace the separate administration of DTPa-IPV/Hib and HBV for the final vaccination at 5 months of age ( Trial DTPa-HBV-IPV-075 ) . MATERIAL S AND METHODS In an open study , 150 children were r and omised to complete their vaccination schedule with DTPa-IPV/Hib + HBV or DTPa-HBV-IPV/Hib . RESULTS One month after the final vaccination , there was no difference between groups in seroprotection rates or antibody concentrations against HBV . Seroprotection rates against diphtheria , tetanus , Hib and polio , as well as vaccine response rates to pertussis antigens were also similar between groups . Local and general symptoms occurred at a similar rate after the third dose of either vaccine . CONCLUSION The immunogenicity and reactogenicity of the hexavalent vaccine DTPa-HBV-IPV/Hib ( Infanrix hexa , GSK ) group is comparable to that of separately administered DTPa-IPV/Hib and HBV vaccines . Combined hexavalent vaccine , DTPa-HBV-IPV/Hib , could replace the separate administration of DTPa-IPV/Hib and HBV for vaccination at 5 months of age , thereby reducing the number of injections required Background and Aims : Assessment of a new , fully liquid , investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine ( Hexaxim , Sanofi Pasteur ) , containing the same active ingredients as Pentaxim ( DTaP-IPV//PRT-T ) and 10 & mgr;g Hansenula polymorpha-derived recombinant hepatitis B ( Hep B ) surface antigen , Sanofi Pasteur , in Argentinean infants . Methods : Infants born to Hep B surface antigen seronegative mothers were r and omized to receive the DTaP-IPV-Hep B-PRP-T vaccine or Pentaxim and Engerix B Pediatrico ( Hep B monovalent ) vaccines at 2 , 4 , 6 months of age . Antibody titers were measured before and 1 month after 3-month primary vaccination . Noninferiority analyses were performed on seroprotection/seroconversion rates . Safety was evaluated descriptively up to 1 month after primary vaccination . Results : A total of 624 participants were enrolled , 312 participants were r and omized to each group , and 604 participants completed the trial . The DTaP-IPV-Hep B-PRP-T vaccine was demonstrated as noninferior to the Pentaxim and Hep B monovalent vaccines with seroprotection/seroconversion rates 1 month postdose 3 for each valence . The anti-Hep B geometric mean titer 1-month postdose 3 for the investigational DTaP-IPV-Hep B-PRP-T primary series was similar to the monovalent Hep B control . The overall incidence of adverse events was similar among the 2 groups . Conclusions : The new , fully liquid , investigational DTaP-IPV-Hep B-PRP-T vaccine ( Hexaxim ) is highly immunogenic and safe when compared with licensed comparators , warranting further development Antibody avidity to Haemophilus influenzae type b ( Hib ) polysaccharide ( PS ) was assessed in infants vaccinated with diphtheria-tetanus-acellular pertussis ( DTaP ) combined with Hib-PS conjugated to tetanus toxoid ( PRP-T ) and hepatitis B ( HB ) ( DTaP-PRP-T-HB )  and after  a PRP-conjugate ( CRM197-OS ) booster 3 - 7 months later . Avidity differed between infants with anti-Hib-PS IgG antibody < 1 or > 1 microg/mL post primary series ( avidity index [ AI ] , 42 % , 95 % confidence interval [ CI ] , 35%-49 % , and 68 % and 63%-72 % , respectively ; P<.0001 ) . For infants with < 1 microgram/mL anti-Hib-PS IgG antibody , mean AI rose by the time of preboost immunization to 61 % ( 95 % CI , 57%-65 % ) , even though total IgG antibody levels fell . Spontaneous Hib-PS antibody rises after primary series DTaP-PRP-T-HB vaccination were followed by high postboost anti-Hib-PS IgG antibody levels and avidity . The DTaP-PRP-T-HB combination vaccine studied elicits high avidity antibody , and affinity maturation appears to occur in the absence of further antigen exposure even in those with very low anti-Hib-PS antibody Abstract Objectives : The aim of this open , r and omised , multicentre trial was to evaluate the immunogenicity and reactogenicity of the tetravalent diphtheria-tetanus-acellular pertussis-hepatitis B ( DTaP-HBV ) vaccine when given either as a mixed or as a separate concomitant injection with the Haemophilus influenzae type b ( Hib ) vaccine  at 3 , 5 and 11 months of age . Methods : Antibody against diphtheria , tetanus , pertussis ( ELISA ) , hepatitis B ( radioimmunoassay ) and Hib polyribosylribitol phosphate ( PRP ) [ radiolabeled antigen binding assay ] was determined . Solicited local and systemic adverse events were evaluated on the day of each vaccination and for three subsequent days . Follow-up of unsolicited and serious adverse events was conducted for 30 days following each vaccination . Results : A total of 360 subjects were enrolled in the study . After completion of the three-dose vaccination course , seroprotective antibody concentrations against diphtheria , tetanus and hepatitis B , together with a pertussis vaccine response , were seen in almost all subjects with immunogenicity results ( n = 336 ) . All subjects had post-vaccination Hib anti-PRP antibody concentrations of at least 0.15 μg/mL , and 97.0 % and 99.4 % , respectively , of the subjects receiving a single or separate injections had Hib anti-PRP antibody concentrations ≥1.0 μg/mL. Addition of the Hib vaccine to the tetravalent DTaP-HBV vaccine did not increase the incidence of local or systemic reactions . Conclusions : Combination of DTaP-HBV and Hib vaccines in a single injection is safe , immunogenic and well tolerated , and thus has the potential to simplify the childhood immunisation schedule in Italy OBJECTIVES To evaluate the immunogenicity and reactogenicity of a pentavalent vaccine prepared by extemporaneously mixing diphtheria-tetanus pertussis-hepatitis B vaccine ( DTP-HBV ) and lyophilised Haemophilus influenzae type B (Hib)-tetanus conjugate vaccines in the same syringe , compared with the same vaccines given as separate , concomitant administrations . DESIGN Open , r and omised comparative study . SETTING Durban , South Africa . SUBJECTS A total of 120 healthy male and female infants were enrolled in the trial and r and omised into two groups ; group 1 received the combined administration ( DTP-HBV-Hib ) , and group 2 received separate administrations of DTP-HBV and Hib vaccines . Vaccines were given as a three-dose primary vaccination course at 2 , 4 and 6 months [ corrected ] of age . OUTCOME MEASURES Antibody levels were measured using st and ard techniques and local and general solicited symptoms were recorded using diary cards . RESULTS All subjects had seroprotective titres against diphtheria and tetanus ; and antipolyribose-ribitol phosphate ( PRP ) titres > or = 0.15 microgram/ml 1 month after the final dose . A vaccine response ( defined as post-vaccination titres > or = 15 ELISA (EL).U/ml in initially seronegative subjects ; and as post-vaccination titres > or = pre-vaccination titres in initially seropositive subjects ) against the pertussis component was seen in 83 % and 85 % of subjects in the groups receiving combined and separate administration . No differences were seen in any of the geometric mean titres ( GMTs ) between the two administrations either 2 months after the second dose or 1 month after the final dose . There was no observed increase in reactogenicity in the group receiving the mixed administration . CONCLUSIONS The results demonstrate that combined DTP-HBV-Hib vaccine is well tolerated and immunogenic OBJECTIVES In this open-label , non-r and omized phase II study , the safety and immunogenicity of a fully liquid diphtheria-tetanus-whole cell pertussis-hepatitis B-Haemophilus influenzae type b ( DTPw-HepB-Hib ) combination vaccine ( Quinvaxem ( ® ) ) were assessed in infants who had or had not received a birth dose of hepatitis B ( HepB ) vaccine . STUDY DESIGN Two groups of infants , ' HepB at birth ' ( n=110 ) and ' no HepB at birth ' ( n=108 ) , were enrolled and received a primary vaccination course using a 2 - 4 - 6 months schedule . RESULTS Seroprotection/seroconversion rates of > 95 % were achieved against all antigens included in the combination vaccine for both study groups . Although significantly higher anti-hepatitis B virus ( p<0.001 ) and anti-tetanus ( p=0.031 ) antibody titers were achieved in group ' HepB at birth ' when compared with group ' no HepB at birth ' , the proportion of ' no HepB at birth ' subjects achieving protective titers was non-inferior to the proportion of subjects in group ' HepB at birth ' . The birth dose of HepB vaccine did not seem to influence the safety pattern of the DTPw-HepB-Hib combination vaccine . CONCLUSIONS The present study demonstrated that the fully liquid DTPw-HepB-Hib vaccine  was safe and immunogenic when administered using a 2 - 4 - 6 months immunization schedule , regardless of whether or not infants had received a dose of HepB vaccine at birth Abstract The lack of an adequate immune response to the major polysaccharide of the Haemophilus influenzae type b ( Hib ) capsule ( polyribosyl ribitol phosphate ) ( PRP ) in very young infants ( < 18 months ) can be overcome by conjugating PRP to a T-cell dependent carrier protein . We studied whether administration of a tetanus-PRP conjugate vaccine reconstituted with a diphtheria-tetanus-acellular pertussis-hepatitis B ( DTPa-HBV ) vaccine as a three dose primary course at 3 , 4 and 5 months of age induced PRP-specific immunological memory , by examining the anti-PRP response to a dose of unconjugated PRP given with the DTPa-HBV booster approximately 1 year later . The unconjugated PRP elicited protective anti-PRP antibody levels ( ≥ 0.15 μg/ml ) in all but 3 of the 369 vaccinees , including 13 infants who failed to demonstrate a measurable immune response after the primary course . In a sub-cohort of 54 subjects all  had anti-PRP levels  ≥ 0.5 μg/ml within 7–14 days of the booster showing a rapid anamnestic type response . Both primary and booster responses were predominantly IgG1 indicating a T-cell dependent response . The DTPa-HBV components elicited protective anti-diphtheria , anti-tetanus and anti-HBs antibody levels in ≥ 98.5 % of vaccinees , and immune responses to each of the acellular pertussis vaccine components in 92.3%–97.3 % of subjects . Conclusion The tetanus-PRP conjugate vaccine not only elicited a good primary humoral response , but also induced immunological memory so that the infants were able to mount a large and rapid immune response to subsequent exposure to plain PRP , indicating that protection against circulating wild-type Hib had been generated . Successful induction of immunological memory occurred even when there was no measurable humoral anti-PRP response to the primary course . Tetanus-PRP conjugate vaccine can be used in combination with DTPa-HBV vaccine , when administered separately or as a single injection in the same syringe , in primary immunisation schedules at 3 , 4 and 5 months of age OBJECTIVES In 1998 the World Health Organization ( WHO ) recommended the inclusion of Haemophilus influenza type B ( Hib ) conjugate vaccines in infant immunization programs , whenever in 
    Output:
    