Safety, tolerability and immunogenicity of a quadrivalent recombinant norovirus vaccine (Pichia pastoris) in participants six weeks of age or older: Phase I/IIa trial.
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| Title: | Safety, tolerability and immunogenicity of a quadrivalent recombinant norovirus vaccine (Pichia pastoris) in participants six weeks of age or older: Phase I/IIa trial. |
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| Authors: | Chen G; Anhui Zhifei Longcom Biopharmaceutical Co. Ltd, Hefei, People's Republic of China., Shi L; Guangxi Zhuang Autonomous Region Disease Control and Prevention Center, Nanning, People's Republic of China., Yu Q; National Institutes for Food and Drug Control, Beijing, People's Republic of China.; State Key Laboratory of Drug Regulatory Science, National Institutes for Food and Drug Control, Beijing, People's Republic of China.; Key Laboratory of Research on Quality and Standardization of Biotech Products, National Health Commission of People's Republic of China, Beijing, People's Republic of China.; Key Laboratory for Quality Research and Evaluation of Biological Products, National Medical Products Administration, Beijing, People's Republic of China.; Research Units of Innovative Vaccine Quality Evaluation and Standardization, Chinese Academy of Medical Sciences, Beijing, People's Republic of China., Liu Q; Chongqing Huazhi Biopharmaceutical Co., Ltd, Chongqing, People's Republic of China., Wang X; Institutes of Biomedical Sciences, Fudan University, Shanghai, People's Republic of China., Liu Y; National Institutes for Food and Drug Control, Beijing, People's Republic of China.; State Key Laboratory of Drug Regulatory Science, National Institutes for Food and Drug Control, Beijing, People's Republic of China.; Key Laboratory of Research on Quality and Standardization of Biotech Products, National Health Commission of People's Republic of China, Beijing, People's Republic of China.; Key Laboratory for Quality Research and Evaluation of Biological Products, National Medical Products Administration, Beijing, People's Republic of China.; Research Units of Innovative Vaccine Quality Evaluation and Standardization, Chinese Academy of Medical Sciences, Beijing, People's Republic of China., Ding F; Anhui Zhifei Longcom Biopharmaceutical Co. Ltd, Hefei, People's Republic of China., Yuan L; Anhui Zhifei Longcom Biopharmaceutical Co. Ltd, Hefei, People's Republic of China., Wang P; Anhui Zhifei Longcom Biopharmaceutical Co. Ltd, Hefei, People's Republic of China., Zhou X; Anhui Zhifei Longcom Biopharmaceutical Co. Ltd, Hefei, People's Republic of China., Zhang Y; National Institutes for Food and Drug Control, Beijing, People's Republic of China.; State Key Laboratory of Drug Regulatory Science, National Institutes for Food and Drug Control, Beijing, People's Republic of China.; Key Laboratory of Research on Quality and Standardization of Biotech Products, National Health Commission of People's Republic of China, Beijing, People's Republic of China.; Key Laboratory for Quality Research and Evaluation of Biological Products, National Medical Products Administration, Beijing, People's Republic of China.; Research Units of Innovative Vaccine Quality Evaluation and Standardization, Chinese Academy of Medical Sciences, Beijing, People's Republic of China., Huang Z; Shanghai Institute of Infectious Disease and Biosecurity, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China., Li J; Anhui Zhifei Longcom Biopharmaceutical Co. Ltd, Hefei, People's Republic of China., Hu Z; National Institutes for Food and Drug Control, Beijing, People's Republic of China.; State Key Laboratory of Drug Regulatory Science, National Institutes for Food and Drug Control, Beijing, People's Republic of China.; Key Laboratory of Research on Quality and Standardization of Biotech Products, National Health Commission of People's Republic of China, Beijing, People's Republic of China.; Key Laboratory for Quality Research and Evaluation of Biological Products, National Medical Products Administration, Beijing, People's Republic of China.; Research Units of Innovative Vaccine Quality Evaluation and Standardization, Chinese Academy of Medical Sciences, Beijing, People's Republic of China., Huang T; Guangxi Zhuang Autonomous Region Disease Control and Prevention Center, Nanning, People's Republic of China. |
| Source: | Emerging microbes & infections [Emerg Microbes Infect] 2025 Dec; Vol. 14 (1), pp. 2565391. Date of Electronic Publication: 2025 Oct 02. |
| Publication Type: | Journal Article; Clinical Trial, Phase I; Randomized Controlled Trial; Clinical Trial, Phase II |
| Journal Info: | Publisher: Taylor & Francis Country of Publication: United States NLM ID: 101594885 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2222-1751 (Electronic) Linking ISSN: 22221751 NLM ISO Abbreviation: Emerg Microbes Infect Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
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| Header | DbId: mdl DbLabel: MEDLINE Ultimate An: 40977245 AccessLevel: 2 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Safety, tolerability and immunogenicity of a quadrivalent recombinant norovirus vaccine (Pichia pastoris) in participants six weeks of age or older: Phase I/IIa trial. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AU" term="%22Chen+G%22">Chen G</searchLink>; Anhui Zhifei Longcom Biopharmaceutical Co. Ltd, Hefei, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Shi+L%22">Shi L</searchLink>; Guangxi Zhuang Autonomous Region Disease Control and Prevention Center, Nanning, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Yu+Q%22">Yu Q</searchLink>; National Institutes for Food and Drug Control, Beijing, People's Republic of China.; State Key Laboratory of Drug Regulatory Science, National Institutes for Food and Drug Control, Beijing, People's Republic of China.; Key Laboratory of Research on Quality and Standardization of Biotech Products, National Health Commission of People's Republic of China, Beijing, People's Republic of China.; Key Laboratory for Quality Research and Evaluation of Biological Products, National Medical Products Administration, Beijing, People's Republic of China.; Research Units of Innovative Vaccine Quality Evaluation and Standardization, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Liu+Q%22">Liu Q</searchLink>; Chongqing Huazhi Biopharmaceutical Co., Ltd, Chongqing, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Wang+X%22">Wang X</searchLink>; Institutes of Biomedical Sciences, Fudan University, Shanghai, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Liu+Y%22">Liu Y</searchLink>; National Institutes for Food and Drug Control, Beijing, People's Republic of China.; State Key Laboratory of Drug Regulatory Science, National Institutes for Food and Drug Control, Beijing, People's Republic of China.; Key Laboratory of Research on Quality and Standardization of Biotech Products, National Health Commission of People's Republic of China, Beijing, People's Republic of China.; Key Laboratory for Quality Research and Evaluation of Biological Products, National Medical Products Administration, Beijing, People's Republic of China.; Research Units of Innovative Vaccine Quality Evaluation and Standardization, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Ding+F%22">Ding F</searchLink>; Anhui Zhifei Longcom Biopharmaceutical Co. Ltd, Hefei, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Yuan+L%22">Yuan L</searchLink>; Anhui Zhifei Longcom Biopharmaceutical Co. Ltd, Hefei, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Wang+P%22">Wang P</searchLink>; Anhui Zhifei Longcom Biopharmaceutical Co. Ltd, Hefei, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Zhou+X%22">Zhou X</searchLink>; Anhui Zhifei Longcom Biopharmaceutical Co. Ltd, Hefei, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Zhang+Y%22">Zhang Y</searchLink>; National Institutes for Food and Drug Control, Beijing, People's Republic of China.; State Key Laboratory of Drug Regulatory Science, National Institutes for Food and Drug Control, Beijing, People's Republic of China.; Key Laboratory of Research on Quality and Standardization of Biotech Products, National Health Commission of People's Republic of China, Beijing, People's Republic of China.; Key Laboratory for Quality Research and Evaluation of Biological Products, National Medical Products Administration, Beijing, People's Republic of China.; Research Units of Innovative Vaccine Quality Evaluation and Standardization, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Huang+Z%22">Huang Z</searchLink>; Shanghai Institute of Infectious Disease and Biosecurity, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Li+J%22">Li J</searchLink>; Anhui Zhifei Longcom Biopharmaceutical Co. Ltd, Hefei, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Hu+Z%22">Hu Z</searchLink>; National Institutes for Food and Drug Control, Beijing, People's Republic of China.; State Key Laboratory of Drug Regulatory Science, National Institutes for Food and Drug Control, Beijing, People's Republic of China.; Key Laboratory of Research on Quality and Standardization of Biotech Products, National Health Commission of People's Republic of China, Beijing, People's Republic of China.; Key Laboratory for Quality Research and Evaluation of Biological Products, National Medical Products Administration, Beijing, People's Republic of China.; Research Units of Innovative Vaccine Quality Evaluation and Standardization, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Huang+T%22">Huang T</searchLink>; Guangxi Zhuang Autonomous Region Disease Control and Prevention Center, Nanning, People's Republic of China. – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22101594885%22">Emerging microbes & infections</searchLink> [Emerg Microbes Infect] 2025 Dec; Vol. 14 (1), pp. 2565391. <i>Date of Electronic Publication: </i>2025 Oct 02. – Name: TypePub Label: Publication Type Group: TypPub Data: Journal Article; Clinical Trial, Phase I; Randomized Controlled Trial; Clinical Trial, Phase II – Name: TitleSource Label: Journal Info Group: Src Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Taylor+%26+Francis%22">Taylor & Francis </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>101594885 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>2222-1751 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2222221751%22">22221751 </searchLink><i>NLM ISO Abbreviation: </i>Emerg Microbes Infect <i>Subsets: </i>MEDLINE |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=40977245 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1080/22221751.2025.2565391 Languages: – Code: eng Text: English PhysicalDescription: Pagination: StartPage: 2565391 Titles: – TitleFull: Safety, tolerability and immunogenicity of a quadrivalent recombinant norovirus vaccine (Pichia pastoris) in participants six weeks of age or older: Phase I/IIa trial. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Chen G – PersonEntity: Name: NameFull: Shi L – PersonEntity: Name: NameFull: Yu Q – PersonEntity: Name: NameFull: Liu Q – PersonEntity: Name: NameFull: Wang X – PersonEntity: Name: NameFull: Liu Y – PersonEntity: Name: NameFull: Ding F – PersonEntity: Name: NameFull: Yuan L – PersonEntity: Name: NameFull: Wang P – PersonEntity: Name: NameFull: Zhou X – PersonEntity: Name: NameFull: Zhang Y – PersonEntity: Name: NameFull: Huang Z – PersonEntity: Name: NameFull: Li J – PersonEntity: Name: NameFull: Hu Z – PersonEntity: Name: NameFull: Huang T IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 12 Text: 2025 Dec Type: published Y: 2025 Identifiers: – Type: issn-electronic Value: 2222-1751 Numbering: – Type: volume Value: 14 – Type: issue Value: 1 Titles: – TitleFull: Emerging microbes & infections Type: main |
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