{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T16:50:16Z","timestamp":1791478216657,"version":"4.3.4"},"reference-count":14,"publisher":"American Society for Microbiology","issue":"12","license":[{"start":{"date-parts":[[2009,12,1]],"date-time":"2009-12-01T00:00:00Z","timestamp":1259625600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Clin Vaccine Immunol"],"published-print":{"date-parts":[[2009,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:p>\n            <jats:italic>Neisseria meningitidis<\/jats:italic>\n            is a leading cause of bacterial meningitis in the United States, with the highest case fatality rates reported for individuals \u226515 years of age. This study compares the safety and immunogenicity of the Novartis Vaccines investigational quadrivalent meningococcal CRM\n            <jats:sub>197<\/jats:sub>\n            conjugate vaccine, MenACWY-CRM, to those of the licensed meningococcal conjugate vaccine, Menactra, when administered to healthy adults. In this phase III multicenter study, 1,359 adults 19 to 55 years of age were randomly assigned to one of four groups (1:1:1:1 ratio) to receive a single dose of one of three lots of MenACWY-CRM or a single dose of Menactra. Serum samples obtained at baseline and 1 month postvaccination were tested for serogroup-specific serum bactericidal activity using human complement (hSBA). The hSBA titers following vaccination with MenACWY-CRM and Menactra were compared in noninferiority and prespecified superiority analyses. Reactogenicity was similar in the MenACWY-CRM and Menactra groups, and neither vaccine was associated with a serious adverse event. When compared with Menactra, MenACWY-CRM met the superiority criteria for the proportions of recipients achieving a seroresponse against serogroups C, W-135, and Y and the proportion of subjects achieving postvaccination titers of \u22651:8 for serogroups C and Y. MenACWY-CRM's immunogenicity was statistically noninferior (the lower limit of the two-sided 95% confidence interval was more than \u221210%) to that of Menactra for all four serogroups, with the postvaccination hSBA geometric mean titers being consistently higher for MenACWY-CRM than for Menactra. MenACWY-CRM is well tolerated in adults 19 to 55 years of age, with immune responses to each of the serogroups noninferior and, in some cases, statistically superior to those to Menactra.\n          <\/jats:p>","DOI":"10.1128\/cvi.00207-09","type":"journal-article","created":{"date-parts":[[2009,10,8]],"date-time":"2009-10-08T01:44:25Z","timestamp":1254966265000},"page":"1810-1815","update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":76,"title":["Quadrivalent Meningococcal Vaccination of Adults: Phase III Comparison of an Investigational Conjugate Vaccine, MenACWY-CRM, with the Licensed Vaccine, Menactra"],"prefix":"10.1128","volume":"16","author":[{"given":"Keith S.","family":"Reisinger","sequence":"first","affiliation":[{"name":"Primary Physicians Research, Pittsburgh, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roger","family":"Baxter","sequence":"additional","affiliation":[{"name":"Kaiser Permanente Vaccine Study Center, Oakland, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stanley L.","family":"Block","sequence":"additional","affiliation":[{"name":"Kentucky Pediatric and Adult Research, Inc., Bardstown, Kentucky"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jina","family":"Shah","sequence":"additional","affiliation":[{"name":"Novartis Vaccines and Diagnostics, Inc., Cambridge, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Bedell","sequence":"additional","affiliation":[{"name":"Novartis Vaccines and Diagnostics, Inc., Cambridge, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter M.","family":"Dull","sequence":"additional","affiliation":[{"name":"Novartis Vaccines and Diagnostics, Inc., Cambridge, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"crossref","first-page":"2284","DOI":"10.1016\/j.vaccine.2008.01.022","volume":"26","year":"2008","unstructured":"Bardotti, A., G. Averani, F. Berti, S. Berti, V. Carinci, S. D'Ascenzi, B. Fabbri, S. Giannini, A. Giannozzi, C. Magagnoli, D. Proietti, F. Norelli, R. Rappuoli, S. Ricci, and P. Costantino. 2008. Physicochemical characterisation of glycoconjugate vaccines for prevention of meningococcal diseases. Vaccine26:2284-2296.","journal-title":"Vaccine"},{"key":"e_1_3_2_3_2","first-page":"1","volume":"54","year":"2005","unstructured":"Bilukha, O. O., and N. Rosenstein. 2005. Prevention and control of meningococcal disease. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recommend. Rep.54(RR-7):1-21.","journal-title":"MMWR Recommend. Rep."},{"key":"e_1_3_2_4_2","unstructured":"Vaccine"},{"key":"e_1_3_2_5_2","doi-asserted-by":"crossref","first-page":"5574","DOI":"10.1016\/j.vaccine.2009.07.036","volume":"27","year":"2009","unstructured":"Br\u00f6ker, M., P. M. Dull, R. Rappuoli, and P. Costantino. 2009. Chemistry of a new investigational quadrivalent meningococcal conjugate vaccine that is immunogenic at all ages. Vaccine27:5574-5580.","journal-title":"Vaccine"},{"key":"e_1_3_2_6_2","first-page":"794","volume":"56","year":"2007","unstructured":"Centers for Disease Control and Prevention. 2007. Revised recommendations of the Advisory Committee on Immunization Practices to vaccinate all persons aged 11-18 years with meningococcal conjugate vaccine. MMWR Morb. Mortal. Wkly. Rep.56:794-795.","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"e_1_3_2_7_2","unstructured":"Active bacterial core surveillance report emerging infections program network Neisseria meningitidis 2007. 2008"},{"key":"e_1_3_2_8_2","doi-asserted-by":"crossref","first-page":"694","DOI":"10.1001\/jama.286.6.694","volume":"286","year":"2001","unstructured":"Harrison, L. H., M. A. Pass, A. B. Mendelsohn, M. Egri, N. E. Rosenstein, A. Bustamante, J. Razeq, and J. C. Roche. 2001. Invasive meningococcal disease in adolescents and young adults. JAMA286:694-699.","journal-title":"JAMA"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.19.1.142-164.2006"},{"key":"e_1_3_2_10_2","doi-asserted-by":"crossref","first-page":"990","DOI":"10.3201\/eid1406.071357","volume":"14","year":"2008","unstructured":"In\u00e9s Agudelo, C., O. M. Sanabria, and M. V. Ovalle. 2008. Serogroup Y meningococcal disease, Colombia. Emerg. Infect. Dis.14:990-991.","journal-title":"Emerg. Infect. Dis."},{"key":"e_1_3_2_11_2","doi-asserted-by":"crossref","first-page":"e1","DOI":"10.1086\/599117","volume":"49","unstructured":"Jackson, L. A., R. Baxter, K. S. Reisinger, A. Karsten, J. Shah, L. Bedell, P. M. Dull, and V59P13 study group. 2009. Phase III, comparison of an investigational quadrivalent meningococcal conjugate vaccine with the licensed meningococcal ACWY conjugate vaccine in adolescents. Clin. Infect. Dis.49:e1-e10.","journal-title":"Clin. Infect. Dis."},{"key":"e_1_3_2_12_2","doi-asserted-by":"crossref","first-page":"86","DOI":"10.1097\/INF.0b013e31818a0237","volume":"28","year":"2009","unstructured":"Jackson, L. A., R. M. Jacobson, K. S. Reisinger, A. Anemona, L. E. Danzig, and P. M. Dull. 2009. A randomized trial to determine the tolerability and immunogenicity of a quadrivalent meningococcal glycoconjugate vaccine in healthy adolescents. Pediatr. Infect. Dis. J.28:86-91.","journal-title":"Pediatr. Infect. Dis. J."},{"key":"e_1_3_2_13_2","doi-asserted-by":"crossref","first-page":"186","DOI":"10.1097\/INF.0b013e31818e037d","volume":"28","year":"2009","unstructured":"Perrett, K. P., M. D. Snape, K. J. Ford, T. M. John, L. M. Yu, J. M. Langley, S. McNeil, P. M. Dull, F. Ceddia, A. Anemona, S. A. Halperin, S. Dobson, and A. J. Pollard. 2009. Immunogenicity and immune memory of a nonadjuvanted quadrivalent meningococcal glycoconjugate vaccine in infants. Pediatr. Infect. Dis. J.28:186-193.","journal-title":"Pediatr. Infect. Dis. J."},{"key":"e_1_3_2_14_2","doi-asserted-by":"crossref","first-page":"1220","DOI":"10.1542\/peds.2004-2514","volume":"115","year":"2005","unstructured":"Shepard, C. W., I. R. Ortega-Sanchez, R. D. Scott II, N. E. Rosenstein, and ABCs Team. 2005. Cost-effectiveness of conjugate meningococcal vaccination strategies in the United States. Pediatrics115:1220-1232.","journal-title":"Pediatrics"},{"key":"e_1_3_2_15_2","first-page":"173","volume":"299","year":"2008","unstructured":"Snape, M. D., K. P. Perrett, K. J. Ford, T. M. John, D. Pace, L. M. Yu, J. M. Langley, S. McNeil, P. M. Dull, F. Ceddia, A. Anemona, S. A. Halperin, S. Dobson, and A. J. Pollard. 2008. Immunogenicity of a tetravalent meningococcal glycoconjugate vaccine in infants: a randomized controlled trial. JAMA299:173-184.","journal-title":"JAMA"}],"container-title":["Clinical and Vaccine Immunology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/CVI.00207-09","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/CVI.00207-09","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,7,29]],"date-time":"2021-07-29T20:41:24Z","timestamp":1627591284000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/CVI.00207-09"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2009,12]]},"references-count":14,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2009,12]]}},"alternative-id":["10.1128\/CVI.00207-09"],"URL":"https:\/\/doi.org\/10.1128\/cvi.00207-09","relation":{},"ISSN":["1556-6811","1556-679X"],"issn-type":[{"value":"1556-6811","type":"print"},{"value":"1556-679X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2009,12]]},"assertion":[{"value":"2009-05-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2009-09-29","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-12-18","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}