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This Phase 1 clinical trial aims to evaluate the safety, immunogenicity, and reactogenicity of the GRT-R910 vaccine, a self-amplifying mRNA vaccine, in healthy adults aged 18 years and older who have previously been vaccinated against COVID-19. The study includes multiple cohorts and will assess different doses and responses to the vaccine.
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Clinical study protocol GO-009 is a structured document that outlines the objectives, design, methodology, and organization of a clinical trial, ensuring the study is conducted consistently and ethically.
Researchers or sponsors conducting a clinical trial must file clinical study protocol GO-009 to regulatory authorities to ensure compliance with applicable regulations.
To fill out clinical study protocol GO-009, follow the prescribed format by providing detailed information on the study objectives, methods, participant criteria, data collection methods, and safety considerations.
The purpose of clinical study protocol GO-009 is to provide a clear plan for the clinical trial, guiding researchers on conducting the study while maintaining participant safety and ensuring the integrity of the data collected.
The information that must be reported on clinical study protocol GO-009 includes study rationale, objectives, study design, participant eligibility criteria, intervention details, data collection methods, statistical analysis plans, and ethical considerations.
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