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: This study was undertaken to assess the co-administration of an experimental measles-mumps-rubella-varicella vaccine ( MMRV , GlaxoSmithKline Biologicals ) with a combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b conjugate ( DTPa-HBV-IPV/Hib ) vaccine in healthy children . Healthy children aged 12–23 months ( N = 451 ) were r and omised to one of three parallel groups to receive one dose of MMRV vaccine co-administered with a booster dose of DTPa-HBV-IPV/Hib vaccine ( co-administration group ) , or one dose of MMRV vaccine alone ( MMRV group ) , or a booster dose of DTPa-HBV-IPV/Hib vaccine alone ( DTPa-HBV-IPV/Hib group ) . No differences in seroconversion rates for measles ( > 95 % ) , mumps ( > 80 % ) , rubella ( > 99 % ) and varicella ( > 98 % ) were seen between the co-administration group and the MMRV group . No differences in geometric mean titres ( GMTs ) were observed between the two groups with the exception of anti-measles titres , which were observed to be higher in the MMRV group than in the co-administration group ( 4,419.2 vs. 3,441.8 mIU/ml respectively ) . Immune response to the booster dose of DTPa-HBV-IPV/Hib vaccine was observed to be similar in the co-administration group and the DTPa-HBV-IPV/Hib group . Co-administration of the MMRV vaccine with a booster dose of DTPa-HBV-IPV/Hib vaccine was well-tolerated and did not exacerbate the reactogenicity profile of either vaccine . In summary , GlaxoSmithKline Biologicals ’ experimental MMRV vaccine was immunogenic and well-tolerated when administered with a booster dose of DTPa-HBV-IPV/Hib vaccine during the second year of life . The ability to co-administer the MMRV vaccine at the same time as other routine childhood immunisation vaccines could increase compliance with varicella vaccination in countries where this vaccine is already recommended and may facilitate implementation of varicella vaccination elsewhere Aim : This study evaluated the immunogenicity and safety of tetravalent measles-mumps-rubella-varicella ( MMRV ) vaccine produced with measles and rubella monovalent bulks derived from a newly established working seed virus stock ( MMRVnew WS ) compared with the combined MMRV vaccine derived from the current seed virus stock , in Taiwanese and Singaporean children ( NCT00892775 ) . Methods : Healthy children aged 11–22 mo were r and omized to receive two doses of either the MMRV new WS vaccine or the MMRV vaccine .  Antibody titers against measles , mumps and rubella were measured using ELISA and against varicella using an immunofluorescence assay . The primary objective was to demonstrate non-inferiority of MMRVnew WS to MMRV in terms of post-dose-1 seroconversion rates , defined as a group difference with a lower limit of the 95 % confidence interval greater than -10 % for each antigen . Parents/guardians recorded symptoms in diary cards for 43 d after each vaccine dose . Results : Non-inferiority of MMRV new WS to MMRV was achieved for all vaccine antigens . The lower limits of the 95 % confidence intervals for group differences ( MMRVnew WS group vs. MMRV ) for measles ( 99.4 % vs 100 % ) , mumps ( 89.7 % vs 90.4 % ) , rubella ( 99.7 % vs 100 % ) and varicella ( 97.6 % vs 92.9 % ) seroconversion rates were greater than -10 % . Mild symptoms including a peak in fever between days 5 and 12 , post-dose-1 , was observed in both groups . Conclusion : The immune responses elicited by the MMRV new WS vaccine were non-inferior to that elicited by the MMRV vaccine for all antigens . Both vaccines exhibited an acceptable safety profile in Taiwanese and Singaporean children In countries where routine varicella vaccination is implemented , it is usually given at the same age as that recommended for measles-mumps-rubella ( MMR ) vaccination . A combined multivalent measles-mumps-rubella-varicella ( MMRV ) vaccine would offer the convenience of a single injection and facilitate implementation of varicella vaccination into routine childhood immunisation schedules . We evaluated the immunogenicity and reactogenicity of a tetravalent MMRV c and i date vaccine compared to an extemporaneous mix of a measles-mumps-rubella vaccine and varicella vaccine ( MMR/V ) , and to a measles-mumps-rubella ( MMR ) vaccine alone . A multicentre study was conducted in which a total of 240 healthy children aged 12 months ( 80 per group ) were r and omised to receive MMRV , MMR/V , or MMR alone . Active surveillance for adverse events was undertaken for 43 days post-vaccination . Blood sample s were taken prior to vaccination and at 60 days post-vaccination . There were no significant differences between groups in rates of pain , redness , or swelling at the site of vaccination . There was no significant difference in the rate of any fever ( axillary temperature > or=37.5 degrees C ) and grade 3 fever ( axillary temperature > 39.0 degrees C ) between the groups receiving MMRV and MMR during the 43-day follow-up period . Although , a significant increase was found for fever of any cause with onset between days 0 and 14 for MMRV compared to the MMR group , there was no significant difference in grade 3 fever rates during the same period . With respect to immunogenicity , MMRV and MMR/V demonstrated similar seroconversion rates to each component compared to MMR alone , with at least 91.9 % of subjects in all groups seroconverting to each vaccine component 60 days after vaccination . Decreased GMTs for varicella antibody at day 60 indicated that there may have been inhibition of this response compared to MMR/V. This tetravalent MMRV c and i date vaccine showed promising results , although further examination of the possible increase in minor fever and decreased varicella immunogenicity should be assessed in future studies OBJECTIVE : We assessed the immunogenicity and safety of a combination measles , mump , rubella , and varicella vaccine ( MMRV ) ( ProQuad [ Merck & Co , Inc , West Point , PA ] ) administered to healthy children concomitantly with a pneumococcal 7-valent conjugate vaccine ( PCV-7 ) ( Prevnar [ Pfizer , Philadelphia , PA ] ) . PATIENTS AND METHODS : Healthy 12- to 15-month-old children who lacked vaccination and clinical histories for measles , mumps , rubella , varicella , and zoster but had written documentation of receipt of a 3-dose primary series of PCV-7  were r and omly assigned in a 2:1:1 ratio to receive either the MMRV and PCV-7 ( group 1 ) , PCV-7 followed 6 weeks later by MMRV ( group 2 ) , or MMRV followed 6 weeks later by PCV-7 ( group 3 ) . The primary safety analysis was 56 days ( 28 days after each visit ) . Immunogenicity was evaluated 6 weeks after each vaccination . RESULTS : A total of 1027 children were enrolled ( group 1 : 510 ; group 2 : 258 ; group 3 : 259 ) . For all 3 groups , the antibody response rate was ≥96.8 % for measles , mumps , and rubella , ≥88.0 % for varicella-zoster virus , and ≥98.3 % for all of the 7 Streptococcus pneumoniae serotypes . The immune responses to all antigens present in MMRV and PCV-7 were similar whether administered concomitantly or sequentially . The incidence of local and systemic adverse experiences ( AEs ) was comparable between group 1 and groups 2 and 3 combined . No vaccine-related serious AEs were reported . CONCLUSIONS : Concomitant administration of the MMRV and PCV-7 is highly immunogenic and generally well tolerated . Similar immune responses between the groups support concomitant administration of the MMRV and PCV-7 to healthy children 12 to 15 months of age Background : A study was conducted to assess administration of a combination measles , mumps , rubella and varicella vaccine ( MMRV ) with other childhood vaccines . Methods : In this open , multicenter trial , 1915 healthy children ages 12–15 months were r and omized into 3 groups : group 1 , MMRV , combined Haemophilus influenzae type b conjugate-hepatitis B vaccines ( Hib/HepB ) and combined diphtheria-tetanus-acellular pertussis vaccines ( DTaP ) concomitantly ; group 2 , MMRV followed by Hib/HepB and DTaP 42 days later ; group 3 , MMR and varicella vaccine followed by Hib/HepB and DTaP 42 days later . Results : Antibody responses to measles , mumps , rubella , varicella , Hib , HepB , diphtheria and tetanus were similar between groups 1 and 2 ( all > 95 % , except varicella , 89.7 % in group 1 and 90.9 % in group 2 ) . Pertussis toxin and filamentous hemagglutinin responses were significantly lower in group 1 than in group 2 ( group 1 , 74.1 and 67.1 % ; group 2 , 90.4 and 86.8 % , respectively ) . An exploratory analysis suggested that the difference in and pertussis toxin and filamentous hemagglutinin responses was likely the result of study design rather than interference among vaccine components because the groups differed in age of receipt of DTaP ( group 1 , ∼12 months ; group 2 , ∼13.5 months ) . When the groups were matched for age , sample size was sufficient for comparison only in children ≥13.5 months old . Pertussis toxin and filamentous hemagglutinin responses were similar in these children . The safety profiles for each vaccination regimen were comparable . Conclusions : The immunogenicity data support concomitant administration of MMRV with Hib/HepB. Limited data from an exploratory analysis indicate that MMRV can be administered concomitantly with DTaP. Concomitant administration of MMRV , Hib/HepB and DTaP  is well-tolerated The objective was to study the incidence of febrile seizures prospect ively determined through age 4 years . A st and ardized r and omized cluster sample of nulliparous pregnant women from a geographically defined area were prospect ively followed from the beginning of pregnancy through the child 's age 4 . Data on children eligible for the study ( n = 1287 ) , including febrile seizures , sociodemographic data , developmental milestones , and chronic diseases , were prospect ively collected from families and health care staff . Data were available for 1033 children . Through age 4 , the average annual incidence of febrile seizures was 14 per 1000 person-years ( 15 for girls and 13.5 for boys ) . The incidence rate through age 4 was 6.9 % ( 7.3 % for girls and 6.5 % for boys ) . The incidence rate of febrile seizures in Finnish children is comparable to that reported previously . The higher figure , based on prospect i ve rather than retrospective data , may give a more accurate picture of the clinical importance of febrile seizures Background : ProQuad , a vaccine containing antigens from M-M-RVAXPRO ( measles , mumps and rubella vaccine ) and VARIVAX ( varicella vaccine ) , is indicated for simultaneous vaccination against measles , mumps , rubella and varicella ( MMRV ) in individuals from 12 months of age . To eliminate blood-derived products of human origin from the manufacturing process of the MMRV vaccine , recombinant human albumin was selected as a replacement for human serum albumin . Methods : This open-label , multicenter clinical trial ( clinical trials.gov identifier NCT00560755 ) was design ed to describe the safety profile of a 2-dose schedule of the MMRV vaccine at a 1-month interval in healthy children aged 12–22 months . Results : In total , 3388 children received at least 1 dose of the MMRV vaccine . Overall , 3376 ( 99.65 % ) children were included in the post-dose 1 safety analysis and 3342 ( 98.64 % ) in the post-dose 2 safety analysis . After doses 1 and 2 , the frequencies of children experiencing solicited injection-site reactions ( post-dose 1 : erythema 14.31 % ; swelling 5.57 % and pain 10.31 % ; post-dose 2 : erythema 30.46 % ; 
    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: This study was undertaken to assess the co-administration of an experimental measles-mumps-rubella-varicella vaccine ( MMRV , GlaxoSmithKline Biologicals ) with a combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b conjugate ( DTPa-HBV-IPV/Hib ) vaccine in healthy children . Healthy children aged 12–23 months ( N = 451 ) were r and omised to one of three parallel groups to receive one dose of MMRV vaccine co-administered with a booster dose of DTPa-HBV-IPV/Hib vaccine ( co-administration group ) , or one dose of MMRV vaccine alone ( MMRV group ) , or a booster dose of DTPa-HBV-IPV/Hib vaccine alone ( DTPa-HBV-IPV/Hib group ) . No differences in seroconversion rates for measles ( > 95 % ) , mumps ( > 80 % ) , rubella ( > 99 % ) and varicella ( > 98 % ) were seen between the co-administration group and the MMRV group . No differences in geometric mean titres ( GMTs ) were observed between the two groups with the exception of anti-measles titres , which were observed to be higher in the MMRV group than in the co-administration group ( 4,419.2 vs. 3,441.8 mIU/ml respectively ) . Immune response to the booster dose of DTPa-HBV-IPV/Hib vaccine was observed to be similar in the co-administration group and the DTPa-HBV-IPV/Hib group . Co-administration of the MMRV vaccine with a booster dose of DTPa-HBV-IPV/Hib vaccine was well-tolerated and did not exacerbate the reactogenicity profile of either vaccine . In summary , GlaxoSmithKline Biologicals ’ experimental MMRV vaccine was immunogenic and well-tolerated when administered with a booster dose of DTPa-HBV-IPV/Hib vaccine during the second year of life . The ability to co-administer the MMRV vaccine at the same time as other routine childhood immunisation vaccines could increase compliance with varicella vaccination in countries where this vaccine is already recommended and may facilitate implementation of varicella vaccination elsewhere Aim : This study evaluated the immunogenicity and safety of tetravalent measles-mumps-rubella-varicella ( MMRV ) vaccine produced with measles and rubella monovalent bulks derived from a newly established working seed virus stock ( MMRVnew WS ) compared with the combined MMRV vaccine derived from the current seed virus stock , in Taiwanese and Singaporean children ( NCT00892775 ) . Methods : Healthy children aged 11–22 mo were r and omized to receive two doses of either the MMRV new WS vaccine or the MMRV vaccine .  Antibody titers against measles , mumps and rubella were measured using ELISA and against varicella using an immunofluorescence assay . The primary objective was to demonstrate non-inferiority of MMRVnew WS to MMRV in terms of post-dose-1 seroconversion rates , defined as a group difference with a lower limit of the 95 % confidence interval greater than -10 % for each antigen . Parents/guardians recorded symptoms in diary cards for 43 d after each vaccine dose . Results : Non-inferiority of MMRV new WS to MMRV was achieved for all vaccine antigens . The lower limits of the 95 % confidence intervals for group differences ( MMRVnew WS group vs. MMRV ) for measles ( 99.4 % vs 100 % ) , mumps ( 89.7 % vs 90.4 % ) , rubella ( 99.7 % vs 100 % ) and varicella ( 97.6 % vs 92.9 % ) seroconversion rates were greater than -10 % . Mild symptoms including a peak in fever between days 5 and 12 , post-dose-1 , was observed in both groups . Conclusion : The immune responses elicited by the MMRV new WS vaccine were non-inferior to that elicited by the MMRV vaccine for all antigens . Both vaccines exhibited an acceptable safety profile in Taiwanese and Singaporean children In countries where routine varicella vaccination is implemented , it is usually given at the same age as that recommended for measles-mumps-rubella ( MMR ) vaccination . A combined multivalent measles-mumps-rubella-varicella ( MMRV ) vaccine would offer the convenience of a single injection and facilitate implementation of varicella vaccination into routine childhood immunisation schedules . We evaluated the immunogenicity and reactogenicity of a tetravalent MMRV c and i date vaccine compared to an extemporaneous mix of a measles-mumps-rubella vaccine and varicella vaccine ( MMR/V ) , and to a measles-mumps-rubella ( MMR ) vaccine alone . A multicentre study was conducted in which a total of 240 healthy children aged 12 months ( 80 per group ) were r and omised to receive MMRV , MMR/V , or MMR alone . Active surveillance for adverse events was undertaken for 43 days post-vaccination . Blood sample s were taken prior to vaccination and at 60 days post-vaccination . There were no significant differences between groups in rates of pain , redness , or swelling at the site of vaccination . There was no significant difference in the rate of any fever ( axillary temperature > or=37.5 degrees C ) and grade 3 fever ( axillary temperature > 39.0 degrees C ) between the groups receiving MMRV and MMR during the 43-day follow-up period . Although , a significant increase was found for fever of any cause with onset between days 0 and 14 for MMRV compared to the MMR group , there was no significant difference in grade 3 fever rates during the same period . With respect to immunogenicity , MMRV and MMR/V demonstrated similar seroconversion rates to each component compared to MMR alone , with at least 91.9 % of subjects in all groups seroconverting to each vaccine component 60 days after vaccination . Decreased GMTs for varicella antibody at day 60 indicated that there may have been inhibition of this response compared to MMR/V. This tetravalent MMRV c and i date vaccine showed promising results , although further examination of the possible increase in minor fever and decreased varicella immunogenicity should be assessed in future studies OBJECTIVE : We assessed the immunogenicity and safety of a combination measles , mump , rubella , and varicella vaccine ( MMRV ) ( ProQuad [ Merck & Co , Inc , West Point , PA ] ) administered to healthy children concomitantly with a pneumococcal 7-valent conjugate vaccine ( PCV-7 ) ( Prevnar [ Pfizer , Philadelphia , PA ] ) . PATIENTS AND METHODS : Healthy 12- to 15-month-old children who lacked vaccination and clinical histories for measles , mumps , rubella , varicella , and zoster but had written documentation of receipt of a 3-dose primary series of PCV-7  were r and omly assigned in a 2:1:1 ratio to receive either the MMRV and PCV-7 ( group 1 ) , PCV-7 followed 6 weeks later by MMRV ( group 2 ) , or MMRV followed 6 weeks later by PCV-7 ( group 3 ) . The primary safety analysis was 56 days ( 28 days after each visit ) . Immunogenicity was evaluated 6 weeks after each vaccination . RESULTS : A total of 1027 children were enrolled ( group 1 : 510 ; group 2 : 258 ; group 3 : 259 ) . For all 3 groups , the antibody response rate was ≥96.8 % for measles , mumps , and rubella , ≥88.0 % for varicella-zoster virus , and ≥98.3 % for all of the 7 Streptococcus pneumoniae serotypes . The immune responses to all antigens present in MMRV and PCV-7 were similar whether administered concomitantly or sequentially . The incidence of local and systemic adverse experiences ( AEs ) was comparable between group 1 and groups 2 and 3 combined . No vaccine-related serious AEs were reported . CONCLUSIONS : Concomitant administration of the MMRV and PCV-7 is highly immunogenic and generally well tolerated . Similar immune responses between the groups support concomitant administration of the MMRV and PCV-7 to healthy children 12 to 15 months of age Background : A study was conducted to assess administration of a combination measles , mumps , rubella and varicella vaccine ( MMRV ) with other childhood vaccines . Methods : In this open , multicenter trial , 1915 healthy children ages 12–15 months were r and omized into 3 groups : group 1 , MMRV , combined Haemophilus influenzae type b conjugate-hepatitis B vaccines ( Hib/HepB ) and combined diphtheria-tetanus-acellular pertussis vaccines ( DTaP ) concomitantly ; group 2 , MMRV followed by Hib/HepB and DTaP 42 days later ; group 3 , MMR and varicella vaccine followed by Hib/HepB and DTaP 42 days later . Results : Antibody responses to measles , mumps , rubella , varicella , Hib , HepB , diphtheria and tetanus were similar between groups 1 and 2 ( all > 95 % , except varicella , 89.7 % in group 1 and 90.9 % in group 2 ) . Pertussis toxin and filamentous hemagglutinin responses were significantly lower in group 1 than in group 2 ( group 1 , 74.1 and 67.1 % ; group 2 , 90.4 and 86.8 % , respectively ) . An exploratory analysis suggested that the difference in and pertussis toxin and filamentous hemagglutinin responses was likely the result of study design rather than interference among vaccine components because the groups differed in age of receipt of DTaP ( group 1 , ∼12 months ; group 2 , ∼13.5 months ) . When the groups were matched for age , sample size was sufficient for comparison only in children ≥13.5 months old . Pertussis toxin and filamentous hemagglutinin responses were similar in these children . The safety profiles for each vaccination regimen were comparable . Conclusions : The immunogenicity data support concomitant administration of MMRV with Hib/HepB. Limited data from an exploratory analysis indicate that MMRV can be administered concomitantly with DTaP. Concomitant administration of MMRV , Hib/HepB and DTaP  is well-tolerated The objective was to study the incidence of febrile seizures prospect ively determined through age 4 years . A st and ardized r and omized cluster sample of nulliparous pregnant women from a geographically defined area were prospect ively followed from the beginning of pregnancy through the child 's age 4 . Data on children eligible for the study ( n = 1287 ) , including febrile seizures , sociodemographic data , developmental milestones , and chronic diseases , were prospect ively collected from families and health care staff . Data were available for 1033 children . Through age 4 , the average annual incidence of febrile seizures was 14 per 1000 person-years ( 15 for girls and 13.5 for boys ) . The incidence rate through age 4 was 6.9 % ( 7.3 % for girls and 6.5 % for boys ) . The incidence rate of febrile seizures in Finnish children is comparable to that reported previously . The higher figure , based on prospect i ve rather than retrospective data , may give a more accurate picture of the clinical importance of febrile seizures Background : ProQuad , a vaccine containing antigens from M-M-RVAXPRO ( measles , mumps and rubella vaccine ) and VARIVAX ( varicella vaccine ) , is indicated for simultaneous vaccination against measles , mumps , rubella and varicella ( MMRV ) in individuals from 12 months of age . To eliminate blood-derived products of human origin from the manufacturing process of the MMRV vaccine , recombinant human albumin was selected as a replacement for human serum albumin . Methods : This open-label , multicenter clinical trial ( clinical trials.gov identifier NCT00560755 ) was design ed to describe the safety profile of a 2-dose schedule of the MMRV vaccine at a 1-month interval in healthy children aged 12–22 months . Results : In total , 3388 children received at least 1 dose of the MMRV vaccine . Overall , 3376 ( 99.65 % ) children were included in the post-dose 1 safety analysis and 3342 ( 98.64 % ) in the post-dose 2 safety analysis . After doses 1 and 2 , the frequencies of children experiencing solicited injection-site reactions ( post-dose 1 : erythema 14.31 % ; swelling 5.57 % and pain 10.31 % ; post-dose 2 : erythema 30.46 % ; 
    Output:
    