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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| ISSN: | 2222-1751 |
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| DOI: | 10.1080/22221751.2025.2565391 |
