Immunogenicity and safety of 1 versus 2 doses of quadrivalent-inactivated influenza vaccine in children aged 3–8 years with or without previous influenza vaccination histories
This study assessed the immunogenicity and safety of a quadrivalent influenza split-virion vaccine (IIV4) in children with and without prior influenza vaccination. An open-label, phase IV clinical trial was conducted in healthy children aged 3–8 years in Pizhou, Jiangsu Province, China. Children wit...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2025-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2025.2468074 |
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| author | Feng Wen Sheng Liu Li Zhou Yinbiao Zhu Wenjuan Wang Mingwei Wei Xinglong Xu Yan Liu Qi Shuai Jun Yu Pengfei Jing Jingxin Li Fengcai Zhu |
| author_facet | Feng Wen Sheng Liu Li Zhou Yinbiao Zhu Wenjuan Wang Mingwei Wei Xinglong Xu Yan Liu Qi Shuai Jun Yu Pengfei Jing Jingxin Li Fengcai Zhu |
| author_sort | Feng Wen |
| collection | DOAJ |
| description | This study assessed the immunogenicity and safety of a quadrivalent influenza split-virion vaccine (IIV4) in children with and without prior influenza vaccination. An open-label, phase IV clinical trial was conducted in healthy children aged 3–8 years in Pizhou, Jiangsu Province, China. Children with ≥2 doses of prior influenza vaccination (Influenza Vaccination Group) and those with no prior vaccination (Influenza Vaccine-naïve Group) were given two doses of IIV4, 4 weeks apart. The primary immunogenicity endpoints were seroprotection rates (SPRs) of hemagglutination inhibition antibody 28 days after each dose against influenza A/H1N1, A/H3N2, B/Yamagata (BY), and B/Victoria (BV). Safety endpoints included adverse events (AEs) within 28 days and serious adverse events (SAEs) within 6 months. Between September 19–25, 2021, 278 participants were screened, and 240 were enrolled (120 per group). In the Influenza Vaccination Group, SPRs after the 2nd dose were 98.28%, 92.24%, 99.14%, and 87.93%, similar to those after the 1st dose (all p > .05). In the Influenza Vaccine-naïve Group, SPRs after the 2nd dose were 99.12%, 96.49%, 99.12%, and 92.11%, significantly higher than after the 1st dose (p < .001 for all strains except BY, p = .070). Most AEs were mild or moderate, with no serious AEs related to the vaccine. Children aged 3–8 years with prior influenza vaccination need only one dose of IIV4, while those without prior vaccination require two doses. ClinicalTrials.gov, the identifier is NCT05144464. |
| format | Article |
| id | doaj-art-3a38e2fd02b04060a170d99072e9c4d1 |
| institution | Kabale University |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-3a38e2fd02b04060a170d99072e9c4d12025-08-20T03:48:14ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2025-12-0121110.1080/21645515.2025.2468074Immunogenicity and safety of 1 versus 2 doses of quadrivalent-inactivated influenza vaccine in children aged 3–8 years with or without previous influenza vaccination historiesFeng Wen0Sheng Liu1Li Zhou2Yinbiao Zhu3Wenjuan Wang4Mingwei Wei5Xinglong Xu6Yan Liu7Qi Shuai8Jun Yu9Pengfei Jing10Jingxin Li11Fengcai Zhu12School of Public Health, Southeast University, Nanjing, ChinaDepartment of Disease Control and Prevention, Pizhou City Center for Disease Control and Prevention, Xuzhou, ChinaDepartment of Vaccine Clinical Evaluation, Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine), Nanjing, ChinaResearch and Development Department, Jiangsu GDK Biological Technology Co. Ltd, Taizhou, ChinaDepartment of Vaccine Clinical Evaluation, Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine), Nanjing, ChinaDepartment of Vaccine Clinical Evaluation, Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine), Nanjing, ChinaResearch and Development Department, Jiangsu GDK Biological Technology Co. Ltd, Taizhou, ChinaResearch and Development Department, Jiangsu GDK Biological Technology Co. Ltd, Taizhou, ChinaResearch and Development Department, Jiangsu GDK Biological Technology Co. Ltd, Taizhou, ChinaResearch and Development Department, Jiangsu GDK Biological Technology Co. Ltd, Taizhou, ChinaDepartment of Vaccine Clinical Evaluation, Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine), Nanjing, ChinaSchool of Public Health, Southeast University, Nanjing, ChinaSchool of Public Health, Southeast University, Nanjing, ChinaThis study assessed the immunogenicity and safety of a quadrivalent influenza split-virion vaccine (IIV4) in children with and without prior influenza vaccination. An open-label, phase IV clinical trial was conducted in healthy children aged 3–8 years in Pizhou, Jiangsu Province, China. Children with ≥2 doses of prior influenza vaccination (Influenza Vaccination Group) and those with no prior vaccination (Influenza Vaccine-naïve Group) were given two doses of IIV4, 4 weeks apart. The primary immunogenicity endpoints were seroprotection rates (SPRs) of hemagglutination inhibition antibody 28 days after each dose against influenza A/H1N1, A/H3N2, B/Yamagata (BY), and B/Victoria (BV). Safety endpoints included adverse events (AEs) within 28 days and serious adverse events (SAEs) within 6 months. Between September 19–25, 2021, 278 participants were screened, and 240 were enrolled (120 per group). In the Influenza Vaccination Group, SPRs after the 2nd dose were 98.28%, 92.24%, 99.14%, and 87.93%, similar to those after the 1st dose (all p > .05). In the Influenza Vaccine-naïve Group, SPRs after the 2nd dose were 99.12%, 96.49%, 99.12%, and 92.11%, significantly higher than after the 1st dose (p < .001 for all strains except BY, p = .070). Most AEs were mild or moderate, with no serious AEs related to the vaccine. Children aged 3–8 years with prior influenza vaccination need only one dose of IIV4, while those without prior vaccination require two doses. ClinicalTrials.gov, the identifier is NCT05144464.https://www.tandfonline.com/doi/10.1080/21645515.2025.2468074Inactivated influenza vaccineimmunogenicitysafetyprevious influenza vaccination1 versus 2 doses |
| spellingShingle | Feng Wen Sheng Liu Li Zhou Yinbiao Zhu Wenjuan Wang Mingwei Wei Xinglong Xu Yan Liu Qi Shuai Jun Yu Pengfei Jing Jingxin Li Fengcai Zhu Immunogenicity and safety of 1 versus 2 doses of quadrivalent-inactivated influenza vaccine in children aged 3–8 years with or without previous influenza vaccination histories Human Vaccines & Immunotherapeutics Inactivated influenza vaccine immunogenicity safety previous influenza vaccination 1 versus 2 doses |
| title | Immunogenicity and safety of 1 versus 2 doses of quadrivalent-inactivated influenza vaccine in children aged 3–8 years with or without previous influenza vaccination histories |
| title_full | Immunogenicity and safety of 1 versus 2 doses of quadrivalent-inactivated influenza vaccine in children aged 3–8 years with or without previous influenza vaccination histories |
| title_fullStr | Immunogenicity and safety of 1 versus 2 doses of quadrivalent-inactivated influenza vaccine in children aged 3–8 years with or without previous influenza vaccination histories |
| title_full_unstemmed | Immunogenicity and safety of 1 versus 2 doses of quadrivalent-inactivated influenza vaccine in children aged 3–8 years with or without previous influenza vaccination histories |
| title_short | Immunogenicity and safety of 1 versus 2 doses of quadrivalent-inactivated influenza vaccine in children aged 3–8 years with or without previous influenza vaccination histories |
| title_sort | immunogenicity and safety of 1 versus 2 doses of quadrivalent inactivated influenza vaccine in children aged 3 8 years with or without previous influenza vaccination histories |
| topic | Inactivated influenza vaccine immunogenicity safety previous influenza vaccination 1 versus 2 doses |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2025.2468074 |
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