Immunogenicity and safety of a novel quadrivalent meningococcal conjugate vaccine (MenACWY-CRM) in healthy Korean adolescents and adults
Objectives: This phase III placebo-controlled study evaluated the immunogenicity and safety of MenACWY-CRM vaccination in healthy Korean adolescents and adults. Methods: Serum bactericidal activity with human complement (hSBA) was measured before and 1 month after vaccination against all four mening...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Hoan Jong Lee [verfasserIn] Moon-Hyun Chung [verfasserIn] Woo Joo Kim [verfasserIn] Young Jin Hong [verfasserIn] Kyong Min Choi [verfasserIn] Jina Lee [verfasserIn] Chi Eun Oh [verfasserIn] Jo Anne Welsch [verfasserIn] Kyung-Hyo Kim [verfasserIn] Ki Bae Hong [verfasserIn] Alemnew F. Dagnew [verfasserIn] Hans Bock [verfasserIn] Peter M. Dull [verfasserIn] Tatjana Odrljin [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2014 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
In: International Journal of Infectious Diseases - Elsevier, 2015, 28(2014), C, Seite 204-210 |
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| Übergeordnetes Werk: |
volume:28 ; year:2014 ; number:C ; pages:204-210 |
| Links: |
Link aufrufen |
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| DOI / URN: |
10.1016/j.ijid.2014.06.008 |
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| Katalog-ID: |
DOAJ022997326 |
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| 245 | 1 | 0 | |a Immunogenicity and safety of a novel quadrivalent meningococcal conjugate vaccine (MenACWY-CRM) in healthy Korean adolescents and adults |
| 264 | 1 | |c 2014 | |
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| 520 | |a Objectives: This phase III placebo-controlled study evaluated the immunogenicity and safety of MenACWY-CRM vaccination in healthy Korean adolescents and adults. Methods: Serum bactericidal activity with human complement (hSBA) was measured before and 1 month after vaccination against all four meningococcal serogroups. The IgG concentration specific for serogroup W capsular polysaccharide was measured in a subset of subjects in a post-hoc analysis. Adverse reactions were monitored throughout the study. Results: Four hundred and fifty subjects were randomized 2:1 to receive MenACWY-CRM (N = 297) or a saline placebo (N = 153). MenACWY-CRM induced a good immune response against all four serogroups, with seroprotection rates (hSBA titers ≥8) of 79%, 99%, 98%, and 94% for serogroups A, C, W, and Y, respectively. Seroresponse rates were high for serogroups A, C, and Y, i.e. 76%, 86%, and 69%, respectively; the rate for serogroup W was 28%. MenACWY-CRM vaccine induced serum bactericidal antibodies against all four serogroups in a majority of subjects regardless of their baseline hSBA titers. MenACWY-CRM was generally well tolerated with most reactions being transient and mild to moderate in severity. Conclusions: Findings of this first study of a quadrivalent meningococcal polysaccharide conjugate vaccine in Korean adults and adolescents demonstrated that a single dose of MenACWY-CRM was well tolerated and immunogenic, as indicated by the percentages of subjects with hSBA titers ≥8 (79%, 99%, 98%, and 94% of subjects) and geometric mean titers (48, 231, 147, and 107) against serogroups A, C, W, and Y, respectively, at 1 month post-vaccination. | ||
| 650 | 4 | |a Neisseria meningitidis | |
| 650 | 4 | |a Conjugate vaccines | |
| 650 | 4 | |a Quadrivalent meningococcal vaccine | |
| 650 | 4 | |a Korea | |
| 653 | 0 | |a Infectious and parasitic diseases | |
| 700 | 0 | |a Moon-Hyun Chung |e verfasserin |4 aut | |
| 700 | 0 | |a Woo Joo Kim |e verfasserin |4 aut | |
| 700 | 0 | |a Young Jin Hong |e verfasserin |4 aut | |
| 700 | 0 | |a Kyong Min Choi |e verfasserin |4 aut | |
| 700 | 0 | |a Jina Lee |e verfasserin |4 aut | |
| 700 | 0 | |a Chi Eun Oh |e verfasserin |4 aut | |
| 700 | 0 | |a Jo Anne Welsch |e verfasserin |4 aut | |
| 700 | 0 | |a Kyung-Hyo Kim |e verfasserin |4 aut | |
| 700 | 0 | |a Ki Bae Hong |e verfasserin |4 aut | |
| 700 | 0 | |a Alemnew F. Dagnew |e verfasserin |4 aut | |
| 700 | 0 | |a Hans Bock |e verfasserin |4 aut | |
| 700 | 0 | |a Peter M. Dull |e verfasserin |4 aut | |
| 700 | 0 | |a Tatjana Odrljin |e verfasserin |4 aut | |
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10.1016/j.ijid.2014.06.008 doi (DE-627)DOAJ022997326 (DE-599)DOAJ284fe328e1174932806b04908c6350dc DE-627 ger DE-627 rakwb eng RC109-216 Hoan Jong Lee verfasserin aut Immunogenicity and safety of a novel quadrivalent meningococcal conjugate vaccine (MenACWY-CRM) in healthy Korean adolescents and adults 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objectives: This phase III placebo-controlled study evaluated the immunogenicity and safety of MenACWY-CRM vaccination in healthy Korean adolescents and adults. Methods: Serum bactericidal activity with human complement (hSBA) was measured before and 1 month after vaccination against all four meningococcal serogroups. The IgG concentration specific for serogroup W capsular polysaccharide was measured in a subset of subjects in a post-hoc analysis. Adverse reactions were monitored throughout the study. Results: Four hundred and fifty subjects were randomized 2:1 to receive MenACWY-CRM (N = 297) or a saline placebo (N = 153). MenACWY-CRM induced a good immune response against all four serogroups, with seroprotection rates (hSBA titers ≥8) of 79%, 99%, 98%, and 94% for serogroups A, C, W, and Y, respectively. Seroresponse rates were high for serogroups A, C, and Y, i.e. 76%, 86%, and 69%, respectively; the rate for serogroup W was 28%. MenACWY-CRM vaccine induced serum bactericidal antibodies against all four serogroups in a majority of subjects regardless of their baseline hSBA titers. MenACWY-CRM was generally well tolerated with most reactions being transient and mild to moderate in severity. Conclusions: Findings of this first study of a quadrivalent meningococcal polysaccharide conjugate vaccine in Korean adults and adolescents demonstrated that a single dose of MenACWY-CRM was well tolerated and immunogenic, as indicated by the percentages of subjects with hSBA titers ≥8 (79%, 99%, 98%, and 94% of subjects) and geometric mean titers (48, 231, 147, and 107) against serogroups A, C, W, and Y, respectively, at 1 month post-vaccination. Neisseria meningitidis Conjugate vaccines Quadrivalent meningococcal vaccine Korea Infectious and parasitic diseases Moon-Hyun Chung verfasserin aut Woo Joo Kim verfasserin aut Young Jin Hong verfasserin aut Kyong Min Choi verfasserin aut Jina Lee verfasserin aut Chi Eun Oh verfasserin aut Jo Anne Welsch verfasserin aut Kyung-Hyo Kim verfasserin aut Ki Bae Hong verfasserin aut Alemnew F. Dagnew verfasserin aut Hans Bock verfasserin aut Peter M. Dull verfasserin aut Tatjana Odrljin verfasserin aut In International Journal of Infectious Diseases Elsevier, 2015 28(2014), C, Seite 204-210 (DE-627)341907669 (DE-600)2070533-5 18783511 nnns volume:28 year:2014 number:C pages:204-210 https://doi.org/10.1016/j.ijid.2014.06.008 kostenfrei https://doaj.org/article/284fe328e1174932806b04908c6350dc kostenfrei http://www.sciencedirect.com/science/article/pii/S1201971214015689 kostenfrei https://doaj.org/toc/1201-9712 Journal toc kostenfrei https://doaj.org/toc/1878-3511 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 28 2014 C 204-210 |
| spelling |
10.1016/j.ijid.2014.06.008 doi (DE-627)DOAJ022997326 (DE-599)DOAJ284fe328e1174932806b04908c6350dc DE-627 ger DE-627 rakwb eng RC109-216 Hoan Jong Lee verfasserin aut Immunogenicity and safety of a novel quadrivalent meningococcal conjugate vaccine (MenACWY-CRM) in healthy Korean adolescents and adults 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objectives: This phase III placebo-controlled study evaluated the immunogenicity and safety of MenACWY-CRM vaccination in healthy Korean adolescents and adults. Methods: Serum bactericidal activity with human complement (hSBA) was measured before and 1 month after vaccination against all four meningococcal serogroups. The IgG concentration specific for serogroup W capsular polysaccharide was measured in a subset of subjects in a post-hoc analysis. Adverse reactions were monitored throughout the study. Results: Four hundred and fifty subjects were randomized 2:1 to receive MenACWY-CRM (N = 297) or a saline placebo (N = 153). MenACWY-CRM induced a good immune response against all four serogroups, with seroprotection rates (hSBA titers ≥8) of 79%, 99%, 98%, and 94% for serogroups A, C, W, and Y, respectively. Seroresponse rates were high for serogroups A, C, and Y, i.e. 76%, 86%, and 69%, respectively; the rate for serogroup W was 28%. MenACWY-CRM vaccine induced serum bactericidal antibodies against all four serogroups in a majority of subjects regardless of their baseline hSBA titers. MenACWY-CRM was generally well tolerated with most reactions being transient and mild to moderate in severity. Conclusions: Findings of this first study of a quadrivalent meningococcal polysaccharide conjugate vaccine in Korean adults and adolescents demonstrated that a single dose of MenACWY-CRM was well tolerated and immunogenic, as indicated by the percentages of subjects with hSBA titers ≥8 (79%, 99%, 98%, and 94% of subjects) and geometric mean titers (48, 231, 147, and 107) against serogroups A, C, W, and Y, respectively, at 1 month post-vaccination. Neisseria meningitidis Conjugate vaccines Quadrivalent meningococcal vaccine Korea Infectious and parasitic diseases Moon-Hyun Chung verfasserin aut Woo Joo Kim verfasserin aut Young Jin Hong verfasserin aut Kyong Min Choi verfasserin aut Jina Lee verfasserin aut Chi Eun Oh verfasserin aut Jo Anne Welsch verfasserin aut Kyung-Hyo Kim verfasserin aut Ki Bae Hong verfasserin aut Alemnew F. Dagnew verfasserin aut Hans Bock verfasserin aut Peter M. Dull verfasserin aut Tatjana Odrljin verfasserin aut In International Journal of Infectious Diseases Elsevier, 2015 28(2014), C, Seite 204-210 (DE-627)341907669 (DE-600)2070533-5 18783511 nnns volume:28 year:2014 number:C pages:204-210 https://doi.org/10.1016/j.ijid.2014.06.008 kostenfrei https://doaj.org/article/284fe328e1174932806b04908c6350dc kostenfrei http://www.sciencedirect.com/science/article/pii/S1201971214015689 kostenfrei https://doaj.org/toc/1201-9712 Journal toc kostenfrei https://doaj.org/toc/1878-3511 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 28 2014 C 204-210 |
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10.1016/j.ijid.2014.06.008 doi (DE-627)DOAJ022997326 (DE-599)DOAJ284fe328e1174932806b04908c6350dc DE-627 ger DE-627 rakwb eng RC109-216 Hoan Jong Lee verfasserin aut Immunogenicity and safety of a novel quadrivalent meningococcal conjugate vaccine (MenACWY-CRM) in healthy Korean adolescents and adults 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objectives: This phase III placebo-controlled study evaluated the immunogenicity and safety of MenACWY-CRM vaccination in healthy Korean adolescents and adults. Methods: Serum bactericidal activity with human complement (hSBA) was measured before and 1 month after vaccination against all four meningococcal serogroups. The IgG concentration specific for serogroup W capsular polysaccharide was measured in a subset of subjects in a post-hoc analysis. Adverse reactions were monitored throughout the study. Results: Four hundred and fifty subjects were randomized 2:1 to receive MenACWY-CRM (N = 297) or a saline placebo (N = 153). MenACWY-CRM induced a good immune response against all four serogroups, with seroprotection rates (hSBA titers ≥8) of 79%, 99%, 98%, and 94% for serogroups A, C, W, and Y, respectively. Seroresponse rates were high for serogroups A, C, and Y, i.e. 76%, 86%, and 69%, respectively; the rate for serogroup W was 28%. MenACWY-CRM vaccine induced serum bactericidal antibodies against all four serogroups in a majority of subjects regardless of their baseline hSBA titers. MenACWY-CRM was generally well tolerated with most reactions being transient and mild to moderate in severity. Conclusions: Findings of this first study of a quadrivalent meningococcal polysaccharide conjugate vaccine in Korean adults and adolescents demonstrated that a single dose of MenACWY-CRM was well tolerated and immunogenic, as indicated by the percentages of subjects with hSBA titers ≥8 (79%, 99%, 98%, and 94% of subjects) and geometric mean titers (48, 231, 147, and 107) against serogroups A, C, W, and Y, respectively, at 1 month post-vaccination. Neisseria meningitidis Conjugate vaccines Quadrivalent meningococcal vaccine Korea Infectious and parasitic diseases Moon-Hyun Chung verfasserin aut Woo Joo Kim verfasserin aut Young Jin Hong verfasserin aut Kyong Min Choi verfasserin aut Jina Lee verfasserin aut Chi Eun Oh verfasserin aut Jo Anne Welsch verfasserin aut Kyung-Hyo Kim verfasserin aut Ki Bae Hong verfasserin aut Alemnew F. Dagnew verfasserin aut Hans Bock verfasserin aut Peter M. Dull verfasserin aut Tatjana Odrljin verfasserin aut In International Journal of Infectious Diseases Elsevier, 2015 28(2014), C, Seite 204-210 (DE-627)341907669 (DE-600)2070533-5 18783511 nnns volume:28 year:2014 number:C pages:204-210 https://doi.org/10.1016/j.ijid.2014.06.008 kostenfrei https://doaj.org/article/284fe328e1174932806b04908c6350dc kostenfrei http://www.sciencedirect.com/science/article/pii/S1201971214015689 kostenfrei https://doaj.org/toc/1201-9712 Journal toc kostenfrei https://doaj.org/toc/1878-3511 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 28 2014 C 204-210 |
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10.1016/j.ijid.2014.06.008 doi (DE-627)DOAJ022997326 (DE-599)DOAJ284fe328e1174932806b04908c6350dc DE-627 ger DE-627 rakwb eng RC109-216 Hoan Jong Lee verfasserin aut Immunogenicity and safety of a novel quadrivalent meningococcal conjugate vaccine (MenACWY-CRM) in healthy Korean adolescents and adults 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objectives: This phase III placebo-controlled study evaluated the immunogenicity and safety of MenACWY-CRM vaccination in healthy Korean adolescents and adults. Methods: Serum bactericidal activity with human complement (hSBA) was measured before and 1 month after vaccination against all four meningococcal serogroups. The IgG concentration specific for serogroup W capsular polysaccharide was measured in a subset of subjects in a post-hoc analysis. Adverse reactions were monitored throughout the study. Results: Four hundred and fifty subjects were randomized 2:1 to receive MenACWY-CRM (N = 297) or a saline placebo (N = 153). MenACWY-CRM induced a good immune response against all four serogroups, with seroprotection rates (hSBA titers ≥8) of 79%, 99%, 98%, and 94% for serogroups A, C, W, and Y, respectively. Seroresponse rates were high for serogroups A, C, and Y, i.e. 76%, 86%, and 69%, respectively; the rate for serogroup W was 28%. MenACWY-CRM vaccine induced serum bactericidal antibodies against all four serogroups in a majority of subjects regardless of their baseline hSBA titers. MenACWY-CRM was generally well tolerated with most reactions being transient and mild to moderate in severity. Conclusions: Findings of this first study of a quadrivalent meningococcal polysaccharide conjugate vaccine in Korean adults and adolescents demonstrated that a single dose of MenACWY-CRM was well tolerated and immunogenic, as indicated by the percentages of subjects with hSBA titers ≥8 (79%, 99%, 98%, and 94% of subjects) and geometric mean titers (48, 231, 147, and 107) against serogroups A, C, W, and Y, respectively, at 1 month post-vaccination. Neisseria meningitidis Conjugate vaccines Quadrivalent meningococcal vaccine Korea Infectious and parasitic diseases Moon-Hyun Chung verfasserin aut Woo Joo Kim verfasserin aut Young Jin Hong verfasserin aut Kyong Min Choi verfasserin aut Jina Lee verfasserin aut Chi Eun Oh verfasserin aut Jo Anne Welsch verfasserin aut Kyung-Hyo Kim verfasserin aut Ki Bae Hong verfasserin aut Alemnew F. Dagnew verfasserin aut Hans Bock verfasserin aut Peter M. Dull verfasserin aut Tatjana Odrljin verfasserin aut In International Journal of Infectious Diseases Elsevier, 2015 28(2014), C, Seite 204-210 (DE-627)341907669 (DE-600)2070533-5 18783511 nnns volume:28 year:2014 number:C pages:204-210 https://doi.org/10.1016/j.ijid.2014.06.008 kostenfrei https://doaj.org/article/284fe328e1174932806b04908c6350dc kostenfrei http://www.sciencedirect.com/science/article/pii/S1201971214015689 kostenfrei https://doaj.org/toc/1201-9712 Journal toc kostenfrei https://doaj.org/toc/1878-3511 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 28 2014 C 204-210 |
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10.1016/j.ijid.2014.06.008 doi (DE-627)DOAJ022997326 (DE-599)DOAJ284fe328e1174932806b04908c6350dc DE-627 ger DE-627 rakwb eng RC109-216 Hoan Jong Lee verfasserin aut Immunogenicity and safety of a novel quadrivalent meningococcal conjugate vaccine (MenACWY-CRM) in healthy Korean adolescents and adults 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objectives: This phase III placebo-controlled study evaluated the immunogenicity and safety of MenACWY-CRM vaccination in healthy Korean adolescents and adults. Methods: Serum bactericidal activity with human complement (hSBA) was measured before and 1 month after vaccination against all four meningococcal serogroups. The IgG concentration specific for serogroup W capsular polysaccharide was measured in a subset of subjects in a post-hoc analysis. Adverse reactions were monitored throughout the study. Results: Four hundred and fifty subjects were randomized 2:1 to receive MenACWY-CRM (N = 297) or a saline placebo (N = 153). MenACWY-CRM induced a good immune response against all four serogroups, with seroprotection rates (hSBA titers ≥8) of 79%, 99%, 98%, and 94% for serogroups A, C, W, and Y, respectively. Seroresponse rates were high for serogroups A, C, and Y, i.e. 76%, 86%, and 69%, respectively; the rate for serogroup W was 28%. MenACWY-CRM vaccine induced serum bactericidal antibodies against all four serogroups in a majority of subjects regardless of their baseline hSBA titers. MenACWY-CRM was generally well tolerated with most reactions being transient and mild to moderate in severity. Conclusions: Findings of this first study of a quadrivalent meningococcal polysaccharide conjugate vaccine in Korean adults and adolescents demonstrated that a single dose of MenACWY-CRM was well tolerated and immunogenic, as indicated by the percentages of subjects with hSBA titers ≥8 (79%, 99%, 98%, and 94% of subjects) and geometric mean titers (48, 231, 147, and 107) against serogroups A, C, W, and Y, respectively, at 1 month post-vaccination. Neisseria meningitidis Conjugate vaccines Quadrivalent meningococcal vaccine Korea Infectious and parasitic diseases Moon-Hyun Chung verfasserin aut Woo Joo Kim verfasserin aut Young Jin Hong verfasserin aut Kyong Min Choi verfasserin aut Jina Lee verfasserin aut Chi Eun Oh verfasserin aut Jo Anne Welsch verfasserin aut Kyung-Hyo Kim verfasserin aut Ki Bae Hong verfasserin aut Alemnew F. Dagnew verfasserin aut Hans Bock verfasserin aut Peter M. Dull verfasserin aut Tatjana Odrljin verfasserin aut In International Journal of Infectious Diseases Elsevier, 2015 28(2014), C, Seite 204-210 (DE-627)341907669 (DE-600)2070533-5 18783511 nnns volume:28 year:2014 number:C pages:204-210 https://doi.org/10.1016/j.ijid.2014.06.008 kostenfrei https://doaj.org/article/284fe328e1174932806b04908c6350dc kostenfrei http://www.sciencedirect.com/science/article/pii/S1201971214015689 kostenfrei https://doaj.org/toc/1201-9712 Journal toc kostenfrei https://doaj.org/toc/1878-3511 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 28 2014 C 204-210 |
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Hoan Jong Lee @@aut@@ Moon-Hyun Chung @@aut@@ Woo Joo Kim @@aut@@ Young Jin Hong @@aut@@ Kyong Min Choi @@aut@@ Jina Lee @@aut@@ Chi Eun Oh @@aut@@ Jo Anne Welsch @@aut@@ Kyung-Hyo Kim @@aut@@ Ki Bae Hong @@aut@@ Alemnew F. Dagnew @@aut@@ Hans Bock @@aut@@ Peter M. Dull @@aut@@ Tatjana Odrljin @@aut@@ |
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Methods: Serum bactericidal activity with human complement (hSBA) was measured before and 1 month after vaccination against all four meningococcal serogroups. The IgG concentration specific for serogroup W capsular polysaccharide was measured in a subset of subjects in a post-hoc analysis. Adverse reactions were monitored throughout the study. Results: Four hundred and fifty subjects were randomized 2:1 to receive MenACWY-CRM (N = 297) or a saline placebo (N = 153). MenACWY-CRM induced a good immune response against all four serogroups, with seroprotection rates (hSBA titers ≥8) of 79%, 99%, 98%, and 94% for serogroups A, C, W, and Y, respectively. Seroresponse rates were high for serogroups A, C, and Y, i.e. 76%, 86%, and 69%, respectively; the rate for serogroup W was 28%. MenACWY-CRM vaccine induced serum bactericidal antibodies against all four serogroups in a majority of subjects regardless of their baseline hSBA titers. 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Hoan Jong Lee |
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Hoan Jong Lee misc RC109-216 misc Neisseria meningitidis misc Conjugate vaccines misc Quadrivalent meningococcal vaccine misc Korea misc Infectious and parasitic diseases Immunogenicity and safety of a novel quadrivalent meningococcal conjugate vaccine (MenACWY-CRM) in healthy Korean adolescents and adults |
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RC109-216 Immunogenicity and safety of a novel quadrivalent meningococcal conjugate vaccine (MenACWY-CRM) in healthy Korean adolescents and adults Neisseria meningitidis Conjugate vaccines Quadrivalent meningococcal vaccine Korea |
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Immunogenicity and safety of a novel quadrivalent meningococcal conjugate vaccine (MenACWY-CRM) in healthy Korean adolescents and adults |
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Hoan Jong Lee Moon-Hyun Chung Woo Joo Kim Young Jin Hong Kyong Min Choi Jina Lee Chi Eun Oh Jo Anne Welsch Kyung-Hyo Kim Ki Bae Hong Alemnew F. Dagnew Hans Bock Peter M. Dull Tatjana Odrljin |
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immunogenicity and safety of a novel quadrivalent meningococcal conjugate vaccine (menacwy-crm) in healthy korean adolescents and adults |
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Immunogenicity and safety of a novel quadrivalent meningococcal conjugate vaccine (MenACWY-CRM) in healthy Korean adolescents and adults |
| abstract |
Objectives: This phase III placebo-controlled study evaluated the immunogenicity and safety of MenACWY-CRM vaccination in healthy Korean adolescents and adults. Methods: Serum bactericidal activity with human complement (hSBA) was measured before and 1 month after vaccination against all four meningococcal serogroups. The IgG concentration specific for serogroup W capsular polysaccharide was measured in a subset of subjects in a post-hoc analysis. Adverse reactions were monitored throughout the study. Results: Four hundred and fifty subjects were randomized 2:1 to receive MenACWY-CRM (N = 297) or a saline placebo (N = 153). MenACWY-CRM induced a good immune response against all four serogroups, with seroprotection rates (hSBA titers ≥8) of 79%, 99%, 98%, and 94% for serogroups A, C, W, and Y, respectively. Seroresponse rates were high for serogroups A, C, and Y, i.e. 76%, 86%, and 69%, respectively; the rate for serogroup W was 28%. MenACWY-CRM vaccine induced serum bactericidal antibodies against all four serogroups in a majority of subjects regardless of their baseline hSBA titers. MenACWY-CRM was generally well tolerated with most reactions being transient and mild to moderate in severity. Conclusions: Findings of this first study of a quadrivalent meningococcal polysaccharide conjugate vaccine in Korean adults and adolescents demonstrated that a single dose of MenACWY-CRM was well tolerated and immunogenic, as indicated by the percentages of subjects with hSBA titers ≥8 (79%, 99%, 98%, and 94% of subjects) and geometric mean titers (48, 231, 147, and 107) against serogroups A, C, W, and Y, respectively, at 1 month post-vaccination. |
| abstractGer |
Objectives: This phase III placebo-controlled study evaluated the immunogenicity and safety of MenACWY-CRM vaccination in healthy Korean adolescents and adults. Methods: Serum bactericidal activity with human complement (hSBA) was measured before and 1 month after vaccination against all four meningococcal serogroups. The IgG concentration specific for serogroup W capsular polysaccharide was measured in a subset of subjects in a post-hoc analysis. Adverse reactions were monitored throughout the study. Results: Four hundred and fifty subjects were randomized 2:1 to receive MenACWY-CRM (N = 297) or a saline placebo (N = 153). MenACWY-CRM induced a good immune response against all four serogroups, with seroprotection rates (hSBA titers ≥8) of 79%, 99%, 98%, and 94% for serogroups A, C, W, and Y, respectively. Seroresponse rates were high for serogroups A, C, and Y, i.e. 76%, 86%, and 69%, respectively; the rate for serogroup W was 28%. MenACWY-CRM vaccine induced serum bactericidal antibodies against all four serogroups in a majority of subjects regardless of their baseline hSBA titers. MenACWY-CRM was generally well tolerated with most reactions being transient and mild to moderate in severity. Conclusions: Findings of this first study of a quadrivalent meningococcal polysaccharide conjugate vaccine in Korean adults and adolescents demonstrated that a single dose of MenACWY-CRM was well tolerated and immunogenic, as indicated by the percentages of subjects with hSBA titers ≥8 (79%, 99%, 98%, and 94% of subjects) and geometric mean titers (48, 231, 147, and 107) against serogroups A, C, W, and Y, respectively, at 1 month post-vaccination. |
| abstract_unstemmed |
Objectives: This phase III placebo-controlled study evaluated the immunogenicity and safety of MenACWY-CRM vaccination in healthy Korean adolescents and adults. Methods: Serum bactericidal activity with human complement (hSBA) was measured before and 1 month after vaccination against all four meningococcal serogroups. The IgG concentration specific for serogroup W capsular polysaccharide was measured in a subset of subjects in a post-hoc analysis. Adverse reactions were monitored throughout the study. Results: Four hundred and fifty subjects were randomized 2:1 to receive MenACWY-CRM (N = 297) or a saline placebo (N = 153). MenACWY-CRM induced a good immune response against all four serogroups, with seroprotection rates (hSBA titers ≥8) of 79%, 99%, 98%, and 94% for serogroups A, C, W, and Y, respectively. Seroresponse rates were high for serogroups A, C, and Y, i.e. 76%, 86%, and 69%, respectively; the rate for serogroup W was 28%. MenACWY-CRM vaccine induced serum bactericidal antibodies against all four serogroups in a majority of subjects regardless of their baseline hSBA titers. MenACWY-CRM was generally well tolerated with most reactions being transient and mild to moderate in severity. Conclusions: Findings of this first study of a quadrivalent meningococcal polysaccharide conjugate vaccine in Korean adults and adolescents demonstrated that a single dose of MenACWY-CRM was well tolerated and immunogenic, as indicated by the percentages of subjects with hSBA titers ≥8 (79%, 99%, 98%, and 94% of subjects) and geometric mean titers (48, 231, 147, and 107) against serogroups A, C, W, and Y, respectively, at 1 month post-vaccination. |
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Immunogenicity and safety of a novel quadrivalent meningococcal conjugate vaccine (MenACWY-CRM) in healthy Korean adolescents and adults |
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https://doi.org/10.1016/j.ijid.2014.06.008 https://doaj.org/article/284fe328e1174932806b04908c6350dc http://www.sciencedirect.com/science/article/pii/S1201971214015689 https://doaj.org/toc/1201-9712 https://doaj.org/toc/1878-3511 |
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Moon-Hyun Chung Woo Joo Kim Young Jin Hong Kyong Min Choi Jina Lee Chi Eun Oh Jo Anne Welsch Kyung-Hyo Kim Ki Bae Hong Alemnew F. Dagnew Hans Bock Peter M. Dull Tatjana Odrljin |
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Moon-Hyun Chung Woo Joo Kim Young Jin Hong Kyong Min Choi Jina Lee Chi Eun Oh Jo Anne Welsch Kyung-Hyo Kim Ki Bae Hong Alemnew F. Dagnew Hans Bock Peter M. Dull Tatjana Odrljin |
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