Safety and immunogenicity of full-dose quadrivalent influenza vaccine in children 6–35 months of age in China: A randomized, double-blind, clinical trial
A half-dose influenza vaccine (7.5 μg hemagglutinin per strain) has been used for children under 3 years of age for a long time. However, several studies indicate that a full-dose influenza vaccine (15 μg hemagglutinin per strain) may bring more benefit to this population without increasing the risk...
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Taylor & Francis Group
2024-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2024.2425149 |
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| author | Shilei Wang Yanxia Wang Dandan Chen Wenting Xu Peng Duan Wei Ji Weijun Liu Weijin Huang Bing Wu Wenqing Chai Chenyan Zhao Yongli Yang Jian Luo Dongyang Zhao Xiuling Li |
| author_facet | Shilei Wang Yanxia Wang Dandan Chen Wenting Xu Peng Duan Wei Ji Weijun Liu Weijin Huang Bing Wu Wenqing Chai Chenyan Zhao Yongli Yang Jian Luo Dongyang Zhao Xiuling Li |
| author_sort | Shilei Wang |
| collection | DOAJ |
| description | A half-dose influenza vaccine (7.5 μg hemagglutinin per strain) has been used for children under 3 years of age for a long time. However, several studies indicate that a full-dose influenza vaccine (15 μg hemagglutinin per strain) may bring more benefit to this population without increasing the risk of adverse reactions. We conducted a clinical study in children aged 6–35 months in China. Participants were randomized to receive two doses of full-dose quadrivalent influenza vaccine (F-QIV), half-dose quadrivalent vaccine (H-QIV), and two half-dose trivalent vaccines (H-TIV) in a 2:2:1:1 ratio. The safety and tolerability profile of the vaccine was evaluated for 6 months postvaccination. Hemagglutination inhibition (HI) antibody titers were measured for immunogenicity assessment. The primary objective was to assess whether the results of all vaccines met the criteria. A total of 1,980 participants were enrolled in the study. Both H-QIV and F-QIV were well tolerated after vaccination. Although the geometric mean increase (GMI), seroconversion rate (SCR), and seroprotection rate (SPR) for both H-QIV and F-QIV were achieved by the criteria, superior immunogenicity in terms of geometric mean titer (GMT) ratio was observed in F-QIV to H-QIV for A/H3N2 (GMT ratio (95% CI) of 1.37 (1.11 ~ 1.68)) and B/Yamagata (1.21 (1.05 ~ 1.39)). Antibody responses to the QIV were non-inferior to the response to the TIV for the matched strains. In conclusion, F-QIV and H-QIV were both safe and immunogenic for children. F-QIV induced a stronger immune response to influenza viruses and may provide more protection and benefit by promoting the use of F-QIV in children aged 6–35 months. |
| format | Article |
| id | doaj-art-da030305055c48bc9018c4e88e8af65b |
| institution | OA Journals |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-da030305055c48bc9018c4e88e8af65b2025-08-20T02:34:25ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2024-12-0120110.1080/21645515.2024.2425149Safety and immunogenicity of full-dose quadrivalent influenza vaccine in children 6–35 months of age in China: A randomized, double-blind, clinical trialShilei Wang0Yanxia Wang1Dandan Chen2Wenting Xu3Peng Duan4Wei Ji5Weijun Liu6Weijin Huang7Bing Wu8Wenqing Chai9Chenyan Zhao10Yongli Yang11Jian Luo12Dongyang Zhao13Xiuling Li14Research and Development Department, Shanghai Institute of Biological Products, Shanghai, ChinaVaccine Clinical Research Center, Henan Provincial Center for Disease Control and Prevention, Zhengzhou, Henan, ChinaResearch and Development Department, Shanghai Institute of Biological Products, Shanghai, ChinaResearch and Development Department, Shanghai Institute of Biological Products, Shanghai, ChinaResearch and Development Department, Shanghai Institute of Biological Products, Shanghai, ChinaProduction Department, Shanghai Institute of Biological Products, Shanghai, ChinaProduction Department, Shanghai Institute of Biological Products, Shanghai, ChinaInstitute for Biological Product Control, National Institutes for Food and Drug Control, Beijing, ChinaResearch and Development Department, Shanghai Institute of Biological Products, Shanghai, ChinaResearch and Development Department, Shanghai Institute of Biological Products, Shanghai, ChinaInstitute for Biological Product Control, National Institutes for Food and Drug Control, Beijing, ChinaCollege of Public Health, Zhengzhou University, Zhengzhou, Henan, ChinaResearch and Development Department, Shanghai Institute of Biological Products, Shanghai, ChinaVaccine Clinical Research Center, Henan Provincial Center for Disease Control and Prevention, Zhengzhou, Henan, ChinaResearch and Development Department, Shanghai Institute of Biological Products, Shanghai, ChinaA half-dose influenza vaccine (7.5 μg hemagglutinin per strain) has been used for children under 3 years of age for a long time. However, several studies indicate that a full-dose influenza vaccine (15 μg hemagglutinin per strain) may bring more benefit to this population without increasing the risk of adverse reactions. We conducted a clinical study in children aged 6–35 months in China. Participants were randomized to receive two doses of full-dose quadrivalent influenza vaccine (F-QIV), half-dose quadrivalent vaccine (H-QIV), and two half-dose trivalent vaccines (H-TIV) in a 2:2:1:1 ratio. The safety and tolerability profile of the vaccine was evaluated for 6 months postvaccination. Hemagglutination inhibition (HI) antibody titers were measured for immunogenicity assessment. The primary objective was to assess whether the results of all vaccines met the criteria. A total of 1,980 participants were enrolled in the study. Both H-QIV and F-QIV were well tolerated after vaccination. Although the geometric mean increase (GMI), seroconversion rate (SCR), and seroprotection rate (SPR) for both H-QIV and F-QIV were achieved by the criteria, superior immunogenicity in terms of geometric mean titer (GMT) ratio was observed in F-QIV to H-QIV for A/H3N2 (GMT ratio (95% CI) of 1.37 (1.11 ~ 1.68)) and B/Yamagata (1.21 (1.05 ~ 1.39)). Antibody responses to the QIV were non-inferior to the response to the TIV for the matched strains. In conclusion, F-QIV and H-QIV were both safe and immunogenic for children. F-QIV induced a stronger immune response to influenza viruses and may provide more protection and benefit by promoting the use of F-QIV in children aged 6–35 months.https://www.tandfonline.com/doi/10.1080/21645515.2024.2425149Quadrivalent influenza vaccinefull-doseclinical trails6–35 monthssafetyimmunogenicity |
| spellingShingle | Shilei Wang Yanxia Wang Dandan Chen Wenting Xu Peng Duan Wei Ji Weijun Liu Weijin Huang Bing Wu Wenqing Chai Chenyan Zhao Yongli Yang Jian Luo Dongyang Zhao Xiuling Li Safety and immunogenicity of full-dose quadrivalent influenza vaccine in children 6–35 months of age in China: A randomized, double-blind, clinical trial Human Vaccines & Immunotherapeutics Quadrivalent influenza vaccine full-dose clinical trails 6–35 months safety immunogenicity |
| title | Safety and immunogenicity of full-dose quadrivalent influenza vaccine in children 6–35 months of age in China: A randomized, double-blind, clinical trial |
| title_full | Safety and immunogenicity of full-dose quadrivalent influenza vaccine in children 6–35 months of age in China: A randomized, double-blind, clinical trial |
| title_fullStr | Safety and immunogenicity of full-dose quadrivalent influenza vaccine in children 6–35 months of age in China: A randomized, double-blind, clinical trial |
| title_full_unstemmed | Safety and immunogenicity of full-dose quadrivalent influenza vaccine in children 6–35 months of age in China: A randomized, double-blind, clinical trial |
| title_short | Safety and immunogenicity of full-dose quadrivalent influenza vaccine in children 6–35 months of age in China: A randomized, double-blind, clinical trial |
| title_sort | safety and immunogenicity of full dose quadrivalent influenza vaccine in children 6 35 months of age in china a randomized double blind clinical trial |
| topic | Quadrivalent influenza vaccine full-dose clinical trails 6–35 months safety immunogenicity |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2024.2425149 |
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