ModernaTX, Inc.
The purpose of this study is to evaluate the immunogenicity and safety of the recommended variant-containing formulations of mRNA-1283 COVID-19 vaccine (mNEXSPIKE®) within the current epidemiological environment.
This study uses a master protocol with a generic study design to allow flexibility in evaluating immunogenicity of variant-containing formulations of the mRNA-1283 COVID-19 vaccine. As different variant-containing vaccine formulations will be evaluated, each study intervention (for example, updated mRNA-1283 COVID-19 vaccine) will be described in the subprotocol. For each evaluation of an updated variant vaccine, a new subprotocol will be generated. Subprotocol 01 is a single arm study to evaluate immunogenicity and safety of mRNA-1283 (COVID-19 vaccine) 2025-2026 formula in individuals aged…
Inclusion Criteria: Subprotocol 1: * ≥65 years of age at the time of signing the informed consent or ≥12 to \<65 years of age at the time of signing the informed consent with at least 1 risk factor for severe outcomes from COVID-19. * Investigator's assessment that the participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures. * Participants who are assigned female at birth or could become pregnant: i) Has a negative pregnancy test at the Screening Visit and on the day of vaccination prior to vaccine dose being administ…
Sterile liquid for injection
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