{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T07:39:57Z","timestamp":1793173197038,"version":"4.5.0"},"reference-count":49,"publisher":"American Society for Microbiology","issue":"10","license":[{"start":{"date-parts":[[2013,10,1]],"date-time":"2013-10-01T00:00:00Z","timestamp":1380585600000},"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":[[2013,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:p>\n            In this study, we compared the immunogenicities of two lots of meningococcal ACWY-tetanus toxoid conjugate vaccine (MenACWY-TT) that differed in serogroup A polysaccharide (PS)\n            <jats:italic>O<\/jats:italic>\n            -acetylation levels and evaluated their immunogenicities and safety in comparison to a licensed ACWY polysaccharide vaccine (Men-PS). In this phase III, partially blinded, controlled study, 1,170 healthy subjects aged 18 to 25 years were randomized (1:1:1) to receive one dose of MenACWY-TT lot A (ACWY-A) (68%\n            <jats:italic>O<\/jats:italic>\n            -acetylation), MenACWY-TT lot B (ACWY-B) (92%\n            <jats:italic>O<\/jats:italic>\n            -acetylation), or Men-PS (82%\n            <jats:italic>O<\/jats:italic>\n            -acetylation). Immunogenicity was evaluated in terms of serum bactericidal activity using rabbit complement (i.e., rabbit serum bactericidal activity [rSBA]). Solicited symptoms, unsolicited adverse events (AEs), and serious AEs (SAEs) were recorded. The immunogenicities, in terms of rSBA geometric mean titers, were comparable for both lots of MenACWY-TT. The vaccine response rates across the serogroups were 79.1 to 97.0% in the two ACWY groups and 73.7 to 94.1% in the Men-PS group. All subjects achieved rSBA titers of \u22651:8 for all serogroups. All subjects in the two ACWY groups and 99.5 to 100% in the Men-PS group achieved rSBA titers of \u22651:128. Pain was the most common solicited local symptom and was reported more frequently in the ACWY group (53.9 to 54.7%) than in the Men-PS group (36.8%). The most common solicited general symptoms were fatigue and headache, which were reported by 28.6 to 30.3% and 26.9 to 31.0% of subjects, respectively. Two subjects reported SAEs; one SAE was considered to be related to vaccination (blighted ovum; ACWY-B group). The level of serogroup A PS\n            <jats:italic>O<\/jats:italic>\n            -acetylation did not affect vaccine immunogenicity. MenACWY-TT (lot A) was not inferior to Men-PS in terms of vaccine response and was well tolerated.\n          <\/jats:p>","DOI":"10.1128\/cvi.00162-13","type":"journal-article","created":{"date-parts":[[2013,7,25]],"date-time":"2013-07-25T01:27:38Z","timestamp":1374715658000},"page":"1499-1507","update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":15,"title":["Meningococcal Polysaccharide A\n            <i>O<\/i>\n            -Acetylation Levels Do Not Impact the Immunogenicity of the Quadrivalent Meningococcal Tetanus Toxoid Conjugate Vaccine: Results from a Randomized, Controlled Phase III Study of Healthy Adults Aged 18 to 25 Years"],"prefix":"10.1128","volume":"20","author":[{"given":"Socorro","family":"Lupisan","sequence":"first","affiliation":[{"name":"Research Institute for Tropical Medicine, Department of Health, Muntinlupa City, Philippines"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kriengsak","family":"Limkittikul","sequence":"additional","affiliation":[{"name":"Department of Tropical Paediatrics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nestor","family":"Sosa","sequence":"additional","affiliation":[{"name":"Pan American Medical Research Center, Panama City, Panama"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pornthep","family":"Chanthavanich","sequence":"additional","affiliation":[{"name":"Department of Tropical Paediatrics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V\u00e9ronique","family":"Bianco","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline Vaccines, Wavre, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yaela","family":"Baine","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie","family":"Van der Wielen","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline Vaccines, Wavre, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacqueline M.","family":"Miller","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1586\/14760584.6.4.485"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2009.04.063"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1097\/01.inf.0000147642.85129.05"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1007\/978-1-61779-346-2_1"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1586\/erv.10.3"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.286.6.694"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1086\/648963"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1574-6976.2006.00051.x"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2009.04.061"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra0906357"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02390-08"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1086\/525260"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1017\/S0950268812001689"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1017\/S0950268811000574"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0929-6646(09)60371-5"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.19.1.142-164.2006"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.2147\/IDR.S21545"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1586\/14760584.5.6.851"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1128\/CVI.05354-11"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1086\/527401"},{"key":"e_1_3_3_22_2","first-page":"1391","article-title":"Recommendation of the Advisory Committee on Immunization Practices (ACIP) for use of quadrivalent meningococcal conjugate vaccine (MenACWY-D) among children aged 9 through 23 months at increased risk for invasive meningococcal disease","volume":"60","author":"Centers for Disease Control and Prevention","year":"2011","unstructured":"Centers for Disease Control and Prevention. 2011. 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