{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,5]],"date-time":"2026-03-05T02:21:23Z","timestamp":1772677283429,"version":"3.50.1"},"reference-count":28,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2020,12,3]],"date-time":"2020-12-03T00:00:00Z","timestamp":1606953600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,4,30]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>The Sinovac enterovirus 71 (EV71) vaccine has been given to children aged 6\u201335 months with good safety, immunogenicity, and efficacy. Further exploration is needed for the application of Sinovac EV71 vaccine in older children.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>A phase III, double-blind, single-center, randomized, controlled, non-inferiority, and bridging-designed trial enrolled 300 participants aged 6\u201335 months and 600 participants aged 36\u201371 months. Non-inferiority and superiority analyses were made to determine the immunogenicity of Sinovac EV71 vaccine in older children (Older-S group), comparing with that of control EV71 vaccine in the same age group (Older-C group), or comparing with that of Sinovac EV71 vaccine in younger children (Younger-S group).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The seroconversion rate of anti-EV71 in Older-S group (95.5%) was superior to that of Older-C group (86.0%), and non-inferior to that of Younger-S group (98.5%). For baseline seronegative participants, the geometric mean titer of Older-S group (370.0) was non-inferior to that of Older-C group (296.2) and superior to that of Younger-S group (176.5). Incidence of adverse reactions in Older-S group (47.0%) was similar to that of Older-C group (44.8%), or Younger-S group (49.8%).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>This study showed good safety and immunogenicity of Sinovac EV71 vaccine in children aged 36\u201371 months.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trials Registration<\/jats:title>\n                  <jats:p>NCT03909074<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>URL<\/jats:title>\n                  <jats:p>https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03909074?term=NCT03909074&amp;draw=2&amp;rank=1<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jpids\/piaa129","type":"journal-article","created":{"date-parts":[[2020,10,27]],"date-time":"2020-10-27T12:34:18Z","timestamp":1603802058000},"page":"440-447","source":"Crossref","is-referenced-by-count":7,"title":["Immunogenicity and Safety of Inactivated Enterovirus 71 Vaccine in Children Aged 36\u201371 Months: A Double-Blind, Randomized, Controlled, Non-inferiority Phase III Trial"],"prefix":"10.1093","volume":"10","author":[{"given":"Lifen","family":"Zhang","sequence":"first","affiliation":[{"name":"Yunnan Center for Disease Control and Prevention, Kunming, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fan","family":"Gao","sequence":"additional","affiliation":[{"name":"National Institutes for Food and Drug Control, Beijing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gang","family":"Zeng","sequence":"additional","affiliation":[{"name":"Sinovac Biotech Co., Ltd, Beijing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Haitao","family":"Yang","sequence":"additional","affiliation":[{"name":"Yunnan Center for Disease Control and Prevention, Kunming, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Taotao","family":"Zhu","sequence":"additional","affiliation":[{"name":"Sinovac Biotech Co., Ltd, Beijing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shuangmin","family":"Yang","sequence":"additional","affiliation":[{"name":"Yunnan Center for Disease Control and Prevention, Kunming, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xing","family":"Meng","sequence":"additional","affiliation":[{"name":"Sinovac Biotech Co., Ltd, Beijing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qunying","family":"Mao","sequence":"additional","affiliation":[{"name":"National Institutes for Food and Drug Control, Beijing, 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