{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T20:18:50Z","timestamp":1787689130312,"version":"build-2784847793"},"reference-count":18,"publisher":"American Society for Microbiology","issue":"12","license":[{"start":{"date-parts":[[2013,12,1]],"date-time":"2013-12-01T00:00:00Z","timestamp":1385856000000},"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":[[2013,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:p>\n            The determination of lot-to-lot consistency in the manufacturing process is a mandatory step in the clinical development of the novel enterovirus 71 (EV71) vaccine. A phase III, randomized, placebo-controlled, double-blind trial assessed the lot consistency, immunogenicity, and safety of the EV71 vaccine in children aged 6 to 59 months. Healthy children (\n            <jats:italic>n<\/jats:italic>\n            = 1,400) received one of three lots of the EV71 vaccine containing 400 U of EV71 antigen or a placebo at days 0 and 28. Blood samples were collected before dose 1 and at 28 days after dose 2 (day 56) for an anti-EV71 neutralizing antibody (NTAb) assay. The geometric mean titer (GMT) and the seropositivity rates (with titers of \u22651:8) were compared at day 56. After each dose, the solicited injection site and general adverse events (AEs) were recorded for 7 days, and unsolicited AEs were recorded for 28 days. At day 56, the seropositivity rates ranged from 99.7% to 100% for the vaccine groups. The NTAb GMTs for the vaccine were 140.3 (95% confidence interval [CI], 117.8 to 167.1), 141.5 (95% CI, 118.0 to 169.6), and 146.6 (95% CI, 122.5 to 175.3). The two-sided 95% CI of the log difference in GMTs between the pairs of lots were between \u22120.176 and 0.176, therefore meeting the predefined equivalence criteria. The percentages of subjects reporting any injection site AEs, general AEs, or serious AEs were similar across the four vaccination groups. In conclusion, the demonstration of consistency between the manufacturing lots confirms for the purposes of clinical development the reliability of the EV71 vaccine production process. (This study has been registered at\n            <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/ClinicalTrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n            under registration no. NCT01636245.)\n          <\/jats:p>","DOI":"10.1128\/cvi.00491-13","type":"journal-article","created":{"date-parts":[[2013,10,10]],"date-time":"2013-10-10T14:56:39Z","timestamp":1381416999000},"page":"1805-1811","update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":31,"title":["Immunogenicity, Safety, and Lot Consistency of a Novel Inactivated Enterovirus 71 Vaccine in Chinese Children Aged 6 to 59 Months"],"prefix":"10.1128","volume":"20","author":[{"given":"Yue-Mei","family":"Hu","sequence":"first","affiliation":[{"name":"Jiang-Su Provincial Center for Disease Control and Prevention, Nanjing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xu","family":"Wang","sequence":"additional","affiliation":[{"name":"Sinovac Biotech Co., Ltd., Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun-Zhi","family":"Wang","sequence":"additional","affiliation":[{"name":"National Institutes for Food and Drug Control, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ling","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Health Statistics, the Fourth Military Medical University, Xi'an, Shanxi Province, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yong-Jie","family":"Zhang","sequence":"additional","affiliation":[{"name":"Jiang-Su Provincial Center for Disease Control and Prevention, Nanjing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lin","family":"Chang","sequence":"additional","affiliation":[{"name":"Sinovac Biotech Co., Ltd., Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zheng-Lun","family":"Liang","sequence":"additional","affiliation":[{"name":"National Institutes for Food and Drug Control, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jie-Lai","family":"Xia","sequence":"additional","affiliation":[{"name":"Department of Health Statistics, the Fourth Military Medical University, Xi'an, Shanxi Province, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qi-Gang","family":"Dai","sequence":"additional","affiliation":[{"name":"Jiang-Su Provincial Center for Disease Control and Prevention, Nanjing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ya-Ling","family":"Hu","sequence":"additional","affiliation":[{"name":"Sinovac Biotech Co., Ltd., Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qun-Ying","family":"Mao","sequence":"additional","affiliation":[{"name":"National Institutes for Food and Drug Control, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Feng-Cai","family":"Zhu","sequence":"additional","affiliation":[{"name":"Jiang-Su Provincial Center for Disease Control and Prevention, Nanjing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu-Fei","family":"Song","sequence":"additional","affiliation":[{"name":"Sinovac Biotech Co., Ltd., Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fan","family":"Gao","sequence":"additional","affiliation":[{"name":"National Institutes for Food and Drug Control, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiang-Ting","family":"Chen","sequence":"additional","affiliation":[{"name":"Sinovac Biotech Co., Ltd., Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"crossref","first-page":"678","DOI":"10.1086\/314032","article-title":"Deaths of children during an outbreak of hand, foot, and mouth disease in sarawak, Malaysia: clinical and pathological characteristics of the disease. 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