{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T00:00:47Z","timestamp":1789430447057,"version":"build-2803163510"},"reference-count":27,"publisher":"Oxford University Press (OUP)","issue":"10","license":[{"start":{"date-parts":[[2019,4,8]],"date-time":"2019-04-08T00:00:00Z","timestamp":1554681600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"name":"Sinovac Biotech"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,10,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>The Sabin strain\u2013based inactivated polio vaccine (sIPV) plays a vital role in eradicating poliomyelitis in developing countries.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>The study was designed as a randomized, controlled, double-blinded, noninferiority trial. A total of 1200 healthy infants aged 60\u201390 days were enrolled and randomly assigned to receive 3 doses of either sIPV (the experimental arm) or IPV (the control arm) at days 0, 30, and 60. Immunogenicity and safety outcomes were assessed using the per-protocol and safety populations, respectively.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A total of 553 and 562 participants in the sIPV and IPV groups, respectively, were included in the per-protocol population. Seroconversion rates in the sIPV and IPV groups were 98.0% and 94.1%, respectively, for type 1 poliovirus (P &lt; .01); 94.8% and 84.0%, respectively, for type 2 (P &lt; .01); and 98.9% and 97.7%, respectively, for type 3 (P = .11). A total of 599 and 600 participants in the sIPV and IPV groups, respectively, were included in the safety population. Fever was the most common adverse event, occurring in 61.6% and 49.8% of participants in the experimental and control arms, respectively (P &lt; .01).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The sIPV demonstrated an immunogenicity profile noninferior to that of the conventional IPV and had a good safety profile.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trials Registration<\/jats:title>\n                  <jats:p>NCT03526978.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/infdis\/jiy736","type":"journal-article","created":{"date-parts":[[2019,3,29]],"date-time":"2019-03-29T08:08:36Z","timestamp":1553846916000},"page":"1551-1557","source":"Crossref","is-referenced-by-count":38,"title":["Immunogenicity and Safety of a Sabin Strain\u2013Based Inactivated Polio Vaccine: A Phase 3 Clinical Trial"],"prefix":"10.1093","volume":"220","author":[{"given":"Yuemei","family":"Hu","sequence":"first","affiliation":[{"name":"Department of Vaccine Evaluation, Nanjing"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianfeng","family":"Wang","sequence":"additional","affiliation":[{"name":"Division of Respiratory Virus Vaccines, National Institute for Food and Drug Control, Sinovac Biotech, Beijing"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gang","family":"Zeng","sequence":"additional","affiliation":[{"name":"Department of Clinical Research, Sinovac Biotech, Beijing"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kai","family":"Chu","sequence":"additional","affiliation":[{"name":"Department of Vaccine Evaluation, Nanjing"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deyu","family":"Jiang","sequence":"additional","affiliation":[{"name":"Center of Research and Development, Sinovac Biotech, Beijing"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fengdong","family":"Zhu","sequence":"additional","affiliation":[{"name":"Guanyun County Center for Disease Control and Prevention, Guanyun"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhifang","family":"Ying","sequence":"additional","affiliation":[{"name":"Division of Respiratory Virus Vaccines, National Institute for Food and Drug Control, Sinovac Biotech, Beijing"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lei","family":"Chen","sequence":"additional","affiliation":[{"name":"Pizhou County Center for Disease Control and Prevention, Pizhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Changgui","family":"Li","sequence":"additional","affiliation":[{"name":"Division of Respiratory Virus Vaccines, National Institute for Food and Drug Control, Sinovac Biotech, Beijing"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fengcai","family":"Zhu","sequence":"additional","affiliation":[{"name":"Office of the Deputy Director, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weidong","family":"Yin","sequence":"additional","affiliation":[{"name":"Office of the General Manager, Sinovac Biotech, Beijing"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2019,4,8]]},"reference":[{"key":"2019100813083761100_CIT0001","unstructured":"Global Polio Eradication Initiative. 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