Phase II Study of a Three-dose Primary Vaccination Course of DTPa-IPV/Hib-MenC-TT Followed by a 12-month Hib-MenC-TT Booster in Healthy Infants
To test for immunologic noninferiority of antibody responses to Hib and MenC using a 6-in-1 combination vaccine (DTPa-IPV/Hib-MenC-TT) compared with DTPa-IPV-Hib plus MenC-CRM197, before and after a 12-month Hib-MenC-TT booster. Pragmatic open-label, randomized, multicenter, UK study. "6-in-1&q...
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| Veröffentlicht in: | The Pediatric infectious disease journal 2013-06, Vol.32 (6), p.675-681 |
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| creator | KHATAMI, Ameneh SNAPE, Matthew D CAUBET, Magalie YU, Ly-Mee HEATH, Paul T FAUST, Saul N FINN, Adam POLLARD, Andrew J OHENE-KENA, Brigitte YOUNG, Katrina OESER, Clarissa MICHAELIS, Louise J MACLEOD, Emma SMEE, Heather VAN DER MEEREN, Olivier LEYSSEN, Maarten |
| description | To test for immunologic noninferiority of antibody responses to Hib and MenC using a 6-in-1 combination vaccine (DTPa-IPV/Hib-MenC-TT) compared with DTPa-IPV-Hib plus MenC-CRM197, before and after a 12-month Hib-MenC-TT booster.
Pragmatic open-label, randomized, multicenter, UK study. "6-in-1" group received DTPa-IPV/Hib-MenC-TT at 2, 3 and 4 months; control group received DTPa-IPV-Hib at 2, 3 and 4 months and MenC-CRM197 at 3 and 4 months. Both groups received Hib-MenC-TT at 12 months. Concomitant vaccines: pneumococcal conjugate vaccine at 2, 4 and 13 months, and measles, mumps and rubella vaccine at 13 months.
One hundred forty-two children were randomized to each group. One hundred children in the "6-in-1" group and 112 control group children completed the study according-to-protocol. One month postprimary immunizations: 100% of "6-in-1" group and 93.3% of control children had anti-polyribosylribitol phosphate (PRP) IgG ≥0.15 µg/mL; 96.2% and 100%, respectively, had rSBA-MenC titers ≥1:8. One month after booster all children met these thresholds, with anti-PRP geometric mean concentrations of 66.7 (53.3; 83.5) in "6-in-1" recipients and 26.9 (20.9; 34.6) in control children (4.4 [3.5; 5.4] and 3.0 [2.2-4.2] postprimary immunizations, respectively,). rSBA-MenC geometric mean titers were 3062.9 (2421.2; 3874.6) and 954.0 (761.3; 1195.5), respectively, postbooster and 393.2 (292.5; 528.7) and 3110.5 (2612; 3704.2) postprimary.
Noninferiority of DTPa-IPV/Hib-MenC-TT compared with DTPa-IPV/Hib plus MenC-CRM197 was demonstrated. In the "6-in-1" group, lower postprimary and greater postbooster rSBA-MenC geometric mean titers suggest memory B-cell priming may be favored by this vaccine over plasma cell induction. Furthermore, greater immunogenicity of TT conjugates used in both primary and booster vaccines in this group may be important. |
| doi_str_mv | 10.1097/INF.0b013e31828672a7 |
| format | Article |
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Pragmatic open-label, randomized, multicenter, UK study. "6-in-1" group received DTPa-IPV/Hib-MenC-TT at 2, 3 and 4 months; control group received DTPa-IPV-Hib at 2, 3 and 4 months and MenC-CRM197 at 3 and 4 months. Both groups received Hib-MenC-TT at 12 months. Concomitant vaccines: pneumococcal conjugate vaccine at 2, 4 and 13 months, and measles, mumps and rubella vaccine at 13 months.
One hundred forty-two children were randomized to each group. One hundred children in the "6-in-1" group and 112 control group children completed the study according-to-protocol. One month postprimary immunizations: 100% of "6-in-1" group and 93.3% of control children had anti-polyribosylribitol phosphate (PRP) IgG ≥0.15 µg/mL; 96.2% and 100%, respectively, had rSBA-MenC titers ≥1:8. One month after booster all children met these thresholds, with anti-PRP geometric mean concentrations of 66.7 (53.3; 83.5) in "6-in-1" recipients and 26.9 (20.9; 34.6) in control children (4.4 [3.5; 5.4] and 3.0 [2.2-4.2] postprimary immunizations, respectively,). rSBA-MenC geometric mean titers were 3062.9 (2421.2; 3874.6) and 954.0 (761.3; 1195.5), respectively, postbooster and 393.2 (292.5; 528.7) and 3110.5 (2612; 3704.2) postprimary.
Noninferiority of DTPa-IPV/Hib-MenC-TT compared with DTPa-IPV/Hib plus MenC-CRM197 was demonstrated. In the "6-in-1" group, lower postprimary and greater postbooster rSBA-MenC geometric mean titers suggest memory B-cell priming may be favored by this vaccine over plasma cell induction. Furthermore, greater immunogenicity of TT conjugates used in both primary and booster vaccines in this group may be important.</description><identifier>ISSN: 0891-3668</identifier><identifier>EISSN: 1532-0987</identifier><identifier>DOI: 10.1097/INF.0b013e31828672a7</identifier><identifier>PMID: 23348809</identifier><identifier>CODEN: PIDJEV</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott Williams & Wilkins</publisher><subject>Antibodies, Bacterial - blood ; Bacterial diseases ; Bacterial diseases of the nervous system. Bacterial myositis ; Biological and medical sciences ; Diphtheria-Tetanus-Pertussis Vaccine - administration & dosage ; Diphtheria-Tetanus-Pertussis Vaccine - immunology ; Female ; Haemophilus Vaccines - administration & dosage ; Haemophilus Vaccines - immunology ; Human bacterial diseases ; Humans ; Immunoglobulin G - blood ; Immunologic Memory ; Infant ; Infectious diseases ; Male ; Medical sciences ; Meningococcal Vaccines - administration & dosage ; Meningococcal Vaccines - immunology ; Poliovirus Vaccine, Inactivated - administration & dosage ; Poliovirus Vaccine, Inactivated - immunology ; United Kingdom ; Vaccination - methods ; Vaccines, Combined - administration & dosage ; Vaccines, Combined - immunology</subject><ispartof>The Pediatric infectious disease journal, 2013-06, Vol.32 (6), p.675-681</ispartof><rights>2014 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c383t-617db187ec5714dcf9c9bdc4289086715291fdc41846eb3489bc954ee570b8803</citedby><cites>FETCH-LOGICAL-c383t-617db187ec5714dcf9c9bdc4289086715291fdc41846eb3489bc954ee570b8803</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27401351$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23348809$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>KHATAMI, Ameneh</creatorcontrib><creatorcontrib>SNAPE, Matthew D</creatorcontrib><creatorcontrib>CAUBET, Magalie</creatorcontrib><creatorcontrib>YU, Ly-Mee</creatorcontrib><creatorcontrib>HEATH, Paul T</creatorcontrib><creatorcontrib>FAUST, Saul N</creatorcontrib><creatorcontrib>FINN, Adam</creatorcontrib><creatorcontrib>POLLARD, Andrew J</creatorcontrib><creatorcontrib>OHENE-KENA, Brigitte</creatorcontrib><creatorcontrib>YOUNG, Katrina</creatorcontrib><creatorcontrib>OESER, Clarissa</creatorcontrib><creatorcontrib>MICHAELIS, Louise J</creatorcontrib><creatorcontrib>MACLEOD, Emma</creatorcontrib><creatorcontrib>SMEE, Heather</creatorcontrib><creatorcontrib>VAN DER MEEREN, Olivier</creatorcontrib><creatorcontrib>LEYSSEN, Maarten</creatorcontrib><title>Phase II Study of a Three-dose Primary Vaccination Course of DTPa-IPV/Hib-MenC-TT Followed by a 12-month Hib-MenC-TT Booster in Healthy Infants</title><title>The Pediatric infectious disease journal</title><addtitle>Pediatr Infect Dis J</addtitle><description>To test for immunologic noninferiority of antibody responses to Hib and MenC using a 6-in-1 combination vaccine (DTPa-IPV/Hib-MenC-TT) compared with DTPa-IPV-Hib plus MenC-CRM197, before and after a 12-month Hib-MenC-TT booster.
Pragmatic open-label, randomized, multicenter, UK study. "6-in-1" group received DTPa-IPV/Hib-MenC-TT at 2, 3 and 4 months; control group received DTPa-IPV-Hib at 2, 3 and 4 months and MenC-CRM197 at 3 and 4 months. Both groups received Hib-MenC-TT at 12 months. Concomitant vaccines: pneumococcal conjugate vaccine at 2, 4 and 13 months, and measles, mumps and rubella vaccine at 13 months.
One hundred forty-two children were randomized to each group. One hundred children in the "6-in-1" group and 112 control group children completed the study according-to-protocol. One month postprimary immunizations: 100% of "6-in-1" group and 93.3% of control children had anti-polyribosylribitol phosphate (PRP) IgG ≥0.15 µg/mL; 96.2% and 100%, respectively, had rSBA-MenC titers ≥1:8. One month after booster all children met these thresholds, with anti-PRP geometric mean concentrations of 66.7 (53.3; 83.5) in "6-in-1" recipients and 26.9 (20.9; 34.6) in control children (4.4 [3.5; 5.4] and 3.0 [2.2-4.2] postprimary immunizations, respectively,). rSBA-MenC geometric mean titers were 3062.9 (2421.2; 3874.6) and 954.0 (761.3; 1195.5), respectively, postbooster and 393.2 (292.5; 528.7) and 3110.5 (2612; 3704.2) postprimary.
Noninferiority of DTPa-IPV/Hib-MenC-TT compared with DTPa-IPV/Hib plus MenC-CRM197 was demonstrated. In the "6-in-1" group, lower postprimary and greater postbooster rSBA-MenC geometric mean titers suggest memory B-cell priming may be favored by this vaccine over plasma cell induction. Furthermore, greater immunogenicity of TT conjugates used in both primary and booster vaccines in this group may be important.</description><subject>Antibodies, Bacterial - blood</subject><subject>Bacterial diseases</subject><subject>Bacterial diseases of the nervous system. Bacterial myositis</subject><subject>Biological and medical sciences</subject><subject>Diphtheria-Tetanus-Pertussis Vaccine - administration & dosage</subject><subject>Diphtheria-Tetanus-Pertussis Vaccine - immunology</subject><subject>Female</subject><subject>Haemophilus Vaccines - administration & dosage</subject><subject>Haemophilus Vaccines - immunology</subject><subject>Human bacterial diseases</subject><subject>Humans</subject><subject>Immunoglobulin G - blood</subject><subject>Immunologic Memory</subject><subject>Infant</subject><subject>Infectious diseases</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Meningococcal Vaccines - administration & dosage</subject><subject>Meningococcal Vaccines - immunology</subject><subject>Poliovirus Vaccine, Inactivated - administration & dosage</subject><subject>Poliovirus Vaccine, Inactivated - immunology</subject><subject>United Kingdom</subject><subject>Vaccination - methods</subject><subject>Vaccines, Combined - administration & dosage</subject><subject>Vaccines, Combined - immunology</subject><issn>0891-3668</issn><issn>1532-0987</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkcFu1DAQhi0Eosu2b1AhX5C4uLVjJ7aPsHTZSAVWatprZDsTbVDWLnaiap-CV8Zot4A4jUbzzT-a_0foktErRrW8rr-ur6iljANnqlCVLIx8gRas5AWhWsmXaEGVZoRXlTpDb1L6TinlgtHX6KzgXChF9QL93O5MAlzX-G6auwMOPTa42UUA0oU82MZhb-IBPxjnBm-mIXi8CnPMo4x-araG1NuH681gyRfwK9I0eB3GMTxBh-0ha7GC7IOfdvhf5GMIaYKIB483YMZpd8C1742f0jl61ZsxwcWpLtH9-qZZbcjtt8_16sMtcVzxiVRMdpYpCa6UTHSu107bzolCaZqtYGWhWZ97pkQFNj-rrdOlACgltflzvkTvj7qPMfyYIU3tfkgOxtF4CHNqmeBUlaLI_i6ROKIuhpQi9O3j0ZSW0fZ3FG2Oov0_irz29nRhtnvo_iw9e5-BdyfAJGfGPhrvhvSXkyIrloz_AskGj4Q</recordid><startdate>20130601</startdate><enddate>20130601</enddate><creator>KHATAMI, Ameneh</creator><creator>SNAPE, Matthew D</creator><creator>CAUBET, Magalie</creator><creator>YU, Ly-Mee</creator><creator>HEATH, Paul T</creator><creator>FAUST, Saul N</creator><creator>FINN, Adam</creator><creator>POLLARD, Andrew J</creator><creator>OHENE-KENA, Brigitte</creator><creator>YOUNG, Katrina</creator><creator>OESER, Clarissa</creator><creator>MICHAELIS, Louise J</creator><creator>MACLEOD, Emma</creator><creator>SMEE, Heather</creator><creator>VAN DER MEEREN, Olivier</creator><creator>LEYSSEN, Maarten</creator><general>Lippincott Williams & Wilkins</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20130601</creationdate><title>Phase II Study of a Three-dose Primary Vaccination Course of DTPa-IPV/Hib-MenC-TT Followed by a 12-month Hib-MenC-TT Booster in Healthy Infants</title><author>KHATAMI, Ameneh ; SNAPE, Matthew D ; CAUBET, Magalie ; YU, Ly-Mee ; HEATH, Paul T ; FAUST, Saul N ; FINN, Adam ; POLLARD, Andrew J ; OHENE-KENA, Brigitte ; YOUNG, Katrina ; OESER, Clarissa ; MICHAELIS, Louise J ; MACLEOD, Emma ; SMEE, Heather ; VAN DER MEEREN, Olivier ; LEYSSEN, Maarten</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c383t-617db187ec5714dcf9c9bdc4289086715291fdc41846eb3489bc954ee570b8803</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Antibodies, Bacterial - blood</topic><topic>Bacterial diseases</topic><topic>Bacterial diseases of the nervous system. Bacterial myositis</topic><topic>Biological and medical sciences</topic><topic>Diphtheria-Tetanus-Pertussis Vaccine - administration & dosage</topic><topic>Diphtheria-Tetanus-Pertussis Vaccine - immunology</topic><topic>Female</topic><topic>Haemophilus Vaccines - administration & dosage</topic><topic>Haemophilus Vaccines - immunology</topic><topic>Human bacterial diseases</topic><topic>Humans</topic><topic>Immunoglobulin G - blood</topic><topic>Immunologic Memory</topic><topic>Infant</topic><topic>Infectious diseases</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Meningococcal Vaccines - administration & dosage</topic><topic>Meningococcal Vaccines - immunology</topic><topic>Poliovirus Vaccine, Inactivated - administration & dosage</topic><topic>Poliovirus Vaccine, Inactivated - immunology</topic><topic>United Kingdom</topic><topic>Vaccination - methods</topic><topic>Vaccines, Combined - administration & dosage</topic><topic>Vaccines, Combined - immunology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>KHATAMI, Ameneh</creatorcontrib><creatorcontrib>SNAPE, Matthew D</creatorcontrib><creatorcontrib>CAUBET, Magalie</creatorcontrib><creatorcontrib>YU, Ly-Mee</creatorcontrib><creatorcontrib>HEATH, Paul T</creatorcontrib><creatorcontrib>FAUST, Saul N</creatorcontrib><creatorcontrib>FINN, Adam</creatorcontrib><creatorcontrib>POLLARD, Andrew J</creatorcontrib><creatorcontrib>OHENE-KENA, Brigitte</creatorcontrib><creatorcontrib>YOUNG, Katrina</creatorcontrib><creatorcontrib>OESER, Clarissa</creatorcontrib><creatorcontrib>MICHAELIS, Louise J</creatorcontrib><creatorcontrib>MACLEOD, Emma</creatorcontrib><creatorcontrib>SMEE, Heather</creatorcontrib><creatorcontrib>VAN DER MEEREN, Olivier</creatorcontrib><creatorcontrib>LEYSSEN, Maarten</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>The Pediatric infectious disease journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>KHATAMI, Ameneh</au><au>SNAPE, Matthew D</au><au>CAUBET, Magalie</au><au>YU, Ly-Mee</au><au>HEATH, Paul T</au><au>FAUST, Saul N</au><au>FINN, Adam</au><au>POLLARD, Andrew J</au><au>OHENE-KENA, Brigitte</au><au>YOUNG, Katrina</au><au>OESER, Clarissa</au><au>MICHAELIS, Louise J</au><au>MACLEOD, Emma</au><au>SMEE, Heather</au><au>VAN DER MEEREN, Olivier</au><au>LEYSSEN, Maarten</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase II Study of a Three-dose Primary Vaccination Course of DTPa-IPV/Hib-MenC-TT Followed by a 12-month Hib-MenC-TT Booster in Healthy Infants</atitle><jtitle>The Pediatric infectious disease journal</jtitle><addtitle>Pediatr Infect Dis J</addtitle><date>2013-06-01</date><risdate>2013</risdate><volume>32</volume><issue>6</issue><spage>675</spage><epage>681</epage><pages>675-681</pages><issn>0891-3668</issn><eissn>1532-0987</eissn><coden>PIDJEV</coden><abstract>To test for immunologic noninferiority of antibody responses to Hib and MenC using a 6-in-1 combination vaccine (DTPa-IPV/Hib-MenC-TT) compared with DTPa-IPV-Hib plus MenC-CRM197, before and after a 12-month Hib-MenC-TT booster.
Pragmatic open-label, randomized, multicenter, UK study. "6-in-1" group received DTPa-IPV/Hib-MenC-TT at 2, 3 and 4 months; control group received DTPa-IPV-Hib at 2, 3 and 4 months and MenC-CRM197 at 3 and 4 months. Both groups received Hib-MenC-TT at 12 months. Concomitant vaccines: pneumococcal conjugate vaccine at 2, 4 and 13 months, and measles, mumps and rubella vaccine at 13 months.
One hundred forty-two children were randomized to each group. One hundred children in the "6-in-1" group and 112 control group children completed the study according-to-protocol. One month postprimary immunizations: 100% of "6-in-1" group and 93.3% of control children had anti-polyribosylribitol phosphate (PRP) IgG ≥0.15 µg/mL; 96.2% and 100%, respectively, had rSBA-MenC titers ≥1:8. One month after booster all children met these thresholds, with anti-PRP geometric mean concentrations of 66.7 (53.3; 83.5) in "6-in-1" recipients and 26.9 (20.9; 34.6) in control children (4.4 [3.5; 5.4] and 3.0 [2.2-4.2] postprimary immunizations, respectively,). rSBA-MenC geometric mean titers were 3062.9 (2421.2; 3874.6) and 954.0 (761.3; 1195.5), respectively, postbooster and 393.2 (292.5; 528.7) and 3110.5 (2612; 3704.2) postprimary.
Noninferiority of DTPa-IPV/Hib-MenC-TT compared with DTPa-IPV/Hib plus MenC-CRM197 was demonstrated. In the "6-in-1" group, lower postprimary and greater postbooster rSBA-MenC geometric mean titers suggest memory B-cell priming may be favored by this vaccine over plasma cell induction. Furthermore, greater immunogenicity of TT conjugates used in both primary and booster vaccines in this group may be important.</abstract><cop>Hagerstown, MD</cop><pub>Lippincott Williams & Wilkins</pub><pmid>23348809</pmid><doi>10.1097/INF.0b013e31828672a7</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | The Pediatric infectious disease journal, 2013-06, Vol.32 (6), p.675-681 |
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| subjects | Antibodies, Bacterial - blood Bacterial diseases Bacterial diseases of the nervous system. Bacterial myositis Biological and medical sciences Diphtheria-Tetanus-Pertussis Vaccine - administration & dosage Diphtheria-Tetanus-Pertussis Vaccine - immunology Female Haemophilus Vaccines - administration & dosage Haemophilus Vaccines - immunology Human bacterial diseases Humans Immunoglobulin G - blood Immunologic Memory Infant Infectious diseases Male Medical sciences Meningococcal Vaccines - administration & dosage Meningococcal Vaccines - immunology Poliovirus Vaccine, Inactivated - administration & dosage Poliovirus Vaccine, Inactivated - immunology United Kingdom Vaccination - methods Vaccines, Combined - administration & dosage Vaccines, Combined - immunology |
| title | Phase II Study of a Three-dose Primary Vaccination Course of DTPa-IPV/Hib-MenC-TT Followed by a 12-month Hib-MenC-TT Booster in Healthy Infants |
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