Comparison of the safety and immunogenicity of two-dose mRNA COVID-19 vaccine and inactivated followed by an mRNA vaccine in children aged 5 - 11 years

Chulalongkorn University0 个研究点目标入组 166 人开始时间: 2022年2月12日最近更新: 2024年8月19日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Chulalongkorn University
入组人数: 166

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

ocal and systemic adverse events which occurred within 7 days after vaccination were mild to moderate and well-tolerated. The PF/PF, SV/PF, and SP/SP/PF groups elicited similar levels of anti- RBD IgG. However, the PF/PF and SP/SP/PF groups elicited higher neutralizing activities against the Omicron BA.2 and BA.5 variant than SV/PF. The SV/PF group elicited low neutralizing activities against the Omicron BA.2 and BA.5 variant. A third dose (booster) mRNA vaccine should be prioritized for this group.

研究设计

研究类型: Interventional

入排标准

年龄范围: 5 Years 至 11 Years（—）
性别: All

入选标准

•1. Healthy children between 5-11 years of age
•2. No history of COVID-19 infection
•3. Parents or guardians live in Bangkok and give informed consent to participate
•4. Children between 7-11 years of age give informed assent to participate

排除标准

•1. History of COVID-19 infection
•2. Immunocompromised status
•3. Bleeding tendency (contraindicated to blood drawing)
•4. History of COVID-19 vaccine allergy or severe reaction from vaccine

研究者

发起方

Chulalongkorn University

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