Safety and Immunogenicity of a New Rotavirus-Inactivated Vaccine in the Chinese Adolescent Population: A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial.

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Title: Safety and Immunogenicity of a New Rotavirus-Inactivated Vaccine in the Chinese Adolescent Population: A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial.
Authors: Liu Y; National Institutes for Food and Drug Control, Beijing 102629, China.; State Key Laboratory of Drug Regulatory Science, Beijing 102629, China., Feng G; Henan Center for Disease Control and Prevention, Zhenzhou 450016, China., Wu J; Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Kunming 650118, China., Liu X; Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Kunming 650118, China., Pu J; Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Kunming 650118, China., Wang Y; Henan Center for Disease Control and Prevention, Zhenzhou 450016, China., You W; Henan Center for Disease Control and Prevention, Zhenzhou 450016, China., Yin N; Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Kunming 650118, China., Yi S; Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Kunming 650118, China., Tan J; Henan Center for Disease Control and Prevention, Zhenzhou 450016, China., Lin X; Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Kunming 650118, China., Huang L; Henan Center for Disease Control and Prevention, Zhenzhou 450016, China., Gao J; National Institutes for Food and Drug Control, Beijing 102629, China.; State Key Laboratory of Drug Regulatory Science, Beijing 102629, China., Yu Q; National Institutes for Food and Drug Control, Beijing 102629, China.; State Key Laboratory of Drug Regulatory Science, Beijing 102629, China., Tong Q; National Institutes for Food and Drug Control, Beijing 102629, China.; State Key Laboratory of Drug Regulatory Science, Beijing 102629, China., Zhang Y; National Institutes for Food and Drug Control, Beijing 102629, China.; State Key Laboratory of Drug Regulatory Science, Beijing 102629, China., Chen R; Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Kunming 650118, China., Hu X; Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Kunming 650118, China., Ye J; Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Kunming 650118, China., Kuang X; Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Kunming 650118, China., Zhou Y; Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Kunming 650118, China., Hu Z; National Institutes for Food and Drug Control, Beijing 102629, China.; State Key Laboratory of Drug Regulatory Science, Beijing 102629, China., Zhao D; Henan Center for Disease Control and Prevention, Zhenzhou 450016, China., Li H; Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Kunming 650118, China.
Source: Vaccines [Vaccines (Basel)] 2025 Mar 30; Vol. 13 (4). Date of Electronic Publication: 2025 Mar 30.
Publication Type: Journal Article
Journal Info: Publisher: MDPI AG Country of Publication: Switzerland NLM ID: 101629355 Publication Model: Electronic Cited Medium: Print ISSN: 2076-393X (Print) Linking ISSN: 2076393X NLM ISO Abbreviation: Vaccines (Basel) Subsets: PubMed not MEDLINE
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  Data: Safety and Immunogenicity of a New Rotavirus-Inactivated Vaccine in the Chinese Adolescent Population: A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial.
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  Data: <searchLink fieldCode="AU" term="%22Liu+Y%22">Liu Y</searchLink>; National Institutes for Food and Drug Control, Beijing 102629, China.; State Key Laboratory of Drug Regulatory Science, Beijing 102629, China.<br /><searchLink fieldCode="AU" term="%22Feng+G%22">Feng G</searchLink>; Henan Center for Disease Control and Prevention, Zhenzhou 450016, China.<br /><searchLink fieldCode="AU" term="%22Wu+J%22">Wu J</searchLink>; Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Kunming 650118, China.<br /><searchLink fieldCode="AU" term="%22Liu+X%22">Liu X</searchLink>; Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Kunming 650118, China.<br /><searchLink fieldCode="AU" term="%22Pu+J%22">Pu J</searchLink>; Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Kunming 650118, China.<br /><searchLink fieldCode="AU" term="%22Wang+Y%22">Wang Y</searchLink>; Henan Center for Disease Control and Prevention, Zhenzhou 450016, China.<br /><searchLink fieldCode="AU" term="%22You+W%22">You W</searchLink>; Henan Center for Disease Control and Prevention, Zhenzhou 450016, China.<br /><searchLink fieldCode="AU" term="%22Yin+N%22">Yin N</searchLink>; Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Kunming 650118, China.<br /><searchLink fieldCode="AU" term="%22Yi+S%22">Yi S</searchLink>; Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Kunming 650118, China.<br /><searchLink fieldCode="AU" term="%22Tan+J%22">Tan J</searchLink>; Henan Center for Disease Control and Prevention, Zhenzhou 450016, China.<br /><searchLink fieldCode="AU" term="%22Lin+X%22">Lin X</searchLink>; Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Kunming 650118, China.<br /><searchLink fieldCode="AU" term="%22Huang+L%22">Huang L</searchLink>; Henan Center for Disease Control and Prevention, Zhenzhou 450016, China.<br /><searchLink fieldCode="AU" term="%22Gao+J%22">Gao J</searchLink>; National Institutes for Food and Drug Control, Beijing 102629, China.; State Key Laboratory of Drug Regulatory Science, Beijing 102629, China.<br /><searchLink fieldCode="AU" term="%22Yu+Q%22">Yu Q</searchLink>; National Institutes for Food and Drug Control, Beijing 102629, China.; State Key Laboratory of Drug Regulatory Science, Beijing 102629, China.<br /><searchLink fieldCode="AU" term="%22Tong+Q%22">Tong Q</searchLink>; National Institutes for Food and Drug Control, Beijing 102629, China.; State Key Laboratory of Drug Regulatory Science, Beijing 102629, China.<br /><searchLink fieldCode="AU" term="%22Zhang+Y%22">Zhang Y</searchLink>; National Institutes for Food and Drug Control, Beijing 102629, China.; State Key Laboratory of Drug Regulatory Science, Beijing 102629, China.<br /><searchLink fieldCode="AU" term="%22Chen+R%22">Chen R</searchLink>; Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Kunming 650118, China.<br /><searchLink fieldCode="AU" term="%22Hu+X%22">Hu X</searchLink>; Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Kunming 650118, China.<br /><searchLink fieldCode="AU" term="%22Ye+J%22">Ye J</searchLink>; Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Kunming 650118, China.<br /><searchLink fieldCode="AU" term="%22Kuang+X%22">Kuang X</searchLink>; Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Kunming 650118, China.<br /><searchLink fieldCode="AU" term="%22Zhou+Y%22">Zhou Y</searchLink>; Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Kunming 650118, China.<br /><searchLink fieldCode="AU" term="%22Hu+Z%22">Hu Z</searchLink>; National Institutes for Food and Drug Control, Beijing 102629, China.; State Key Laboratory of Drug Regulatory Science, Beijing 102629, China.<br /><searchLink fieldCode="AU" term="%22Zhao+D%22">Zhao D</searchLink>; Henan Center for Disease Control and Prevention, Zhenzhou 450016, China.<br /><searchLink fieldCode="AU" term="%22Li+H%22">Li H</searchLink>; Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Kunming 650118, China.
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  Data: <searchLink fieldCode="JN" term="%22101629355%22">Vaccines</searchLink> [Vaccines (Basel)] 2025 Mar 30; Vol. 13 (4). <i>Date of Electronic Publication: </i>2025 Mar 30.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22MDPI+AG%22">MDPI AG </searchLink><i>Country of Publication: </i>Switzerland <i>NLM ID: </i>101629355 <i>Publication Model: </i>Electronic <i>Cited Medium: </i>Print <i>ISSN: </i>2076-393X (Print) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%222076393X%22">2076393X </searchLink><i>NLM ISO Abbreviation: </i>Vaccines (Basel) <i>Subsets: </i>PubMed not MEDLINE
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        Value: 10.3390/vaccines13040369
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      – TitleFull: Safety and Immunogenicity of a New Rotavirus-Inactivated Vaccine in the Chinese Adolescent Population: A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial.
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