{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T02:29:19Z","timestamp":1740104959094,"version":"3.37.3"},"reference-count":21,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2019,3,5]],"date-time":"2019-03-05T00:00:00Z","timestamp":1551744000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100014588","name":"Sanofi Pasteur","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100014588","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2019,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>Meningococcal disease is a major global health concern due to its severe and sudden clinical manifestations, devastating long\u2010term sequelae, and predominance in younger age groups. This study evaluated the safety of a quadrivalent meningococcal polysaccharide diphtheria toxoid conjugate vaccine (MenACWY\u2010D; Menactra) in participants aged 9\u00a0months to 55\u00a0years in Vietnam.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This was an open\u2010label, single\u2010arm study conducted between June and December 2016. Participants received one 0.5\u2010mL dose of the vaccine, and those aged 9 to 23\u00a0months received a second 0.5\u2010mL dose 3\u00a0months later. Participants (or their parents or legal guardians) reported adverse events during the 28\u00a0days after each dose.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The study included 112 participants aged 9 to 23\u00a0months and 112 participants aged 2 to 55\u00a0years. Of these 224 participants, 100 (44.6%) had one or more solicited reactions within 7\u00a0days following any MenACWY\u2010D dose, mostly injection site pain, lost appetite (in 9 to 23\u2010month\u2010olds), and malaise (in 2 to 55\u2010year\u2010olds). Most solicited reactions were of mild or moderate intensity and resolved within 3\u00a0days. Five participants had unsolicited adverse reactions (ARs), two of which (tonsillitis and febrile convulsion), in 9 to 23\u2010month\u2010olds, were considered by the investigator as serious adverse events related to the vaccine. No immediate unsolicited ARs, severe unsolicited nonserious ARs, or unsolicited injection site reactions were reported, and both participants who experienced vaccine\u2010related serious adverse events recovered.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Consistent with studies in other countries, MenACWY\u2010D had an acceptable safety profile in individuals from Vietnam aged 9\u00a0months to 55\u00a0years (WHO Universal Trial Number: U1111\u20101143\u20109207).<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.4754","type":"journal-article","created":{"date-parts":[[2019,3,6]],"date-time":"2019-03-06T04:44:52Z","timestamp":1551847492000},"page":"515-520","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Safety of a quadrivalent meningococcal conjugate vaccine in healthy subjects aged 9 months to 55 years in Vietnam"],"prefix":"10.1002","volume":"28","author":[{"given":"Cong Hung","family":"Phan","sequence":"first","affiliation":[{"name":"Pasteur Institute  Ho Chi Minh City Vietnam"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thi Phuong Thuy","family":"Nguyen","sequence":"additional","affiliation":[{"name":"Pasteur Institute  Ho Chi Minh City Vietnam"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Uyen Y.","family":"Doan","sequence":"additional","affiliation":[{"name":"Pasteur Institute  Ho Chi Minh City Vietnam"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thuy An","family":"Nguyen","sequence":"additional","affiliation":[{"name":"Sanofi Pasteur  Ho Chi Minh City Vietnam"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ya\u00ebl","family":"Thollot","sequence":"additional","affiliation":[{"name":"Pasteur Medical Operations, Sanofi Pasteur  Lyon France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5398-9199","authenticated-orcid":false,"given":"Maria Carmen","family":"Nievera","sequence":"additional","affiliation":[{"name":"Sanofi Pasteur Asia Pacific  Taguig Philippines"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,3,5]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2011.12.062"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.4161\/hv.27739"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/archdischild-2012-302036"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2009.05.003"},{"key":"e_1_2_10_6_1","first-page":"e158","article-title":"Impact and effectiveness of meningococcal vaccines: a review","volume":"41","author":"De Oliveira LH","year":"2017","journal-title":"Rev Panam Salud Publica"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1017\/S0950268811000574"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.2006.74.509"},{"key":"e_1_2_10_9_1","unstructured":"'Meningococcal meningitis spreads in five Vietnam localities'.DTI News Dantri International. 31 January 2012. 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