A Phase III, Multicenter, Open-Label, Parallel-Group, Comparative Study to Evaluate the Immunogenicity and Safety of CSL402 (Self-Amplifying mRNA COVID-19 Vaccine) in Subjects Aged 12 Years or Older

Meiji Seika Pharma Co.,Ltd.0 个研究点目标入组 560 人开始时间: 2024年10月28日最近更新: 2025年1月10日

适应症

试验速览

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•(1) Subjects (irrespective of gender) must be healthy and >=12 years of age at screening.
•(2) Subjects must freely provide documented informed consent. Children who are younger than 18 years of age must have the written consent of a legally acceptable representative and must personally consent using a consent form or assent form.
•(3) Subjects must have received at least 2 doses of an authorized mRNA COVID-19 vaccine (COMIRNATY or SPIKEVAX) and satisfy the following criteria:
•(a) Received 2 doses of an authorized mRNA COVID-19 vaccine (monovalent: Wuhan strain) as initial immunization
•(b) At the time of screening, at least 3 months have passed since the last vaccination
•(c) Receipt of these vaccines is supported by documentation, etc.

•(1) Individuals with acute medical illness or fever of >= 37.5 degree celcius within 1 day prior to screening. These individuals may be offered the opportunity to enter the study after fever and illness have resolved.
•(2) Individuals with a positive SARS-CoV-2 antigen test at screening or confirmed SARS-Cov-2 infection in a family member with whom they live.
•(3) Individuals with a confirmed SARS-CoV-2 infection or history of COVID-19 with ongoing sequelae within 6 months.

Geometric mean titer (GMT) of neutralizing antibodies against SARS-CoV-2 (Omicron JN.1) on Day 29

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