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About
The purpose of this study is to evaluate the immunogenicity and safety of variant-containing formulations of mRNA-1283 COVID-19 vaccine (mNEXSPIKE®) within the current epidemiological environment.
Full description
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 (eg, 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 ≥65 years and ≥12 to <65 years with at least 1 underlying condition that puts them at high risk for severe outcomes from COVID-19.
Enrollment
Sex
Ages
Volunteers
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 administered on Day 1.
ii) Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 1).
iii) Has agreed to continue adequate contraception through 28 days following vaccine administration.
Exclusion criteria
Subprotocol 1:
Note: Other protocol-specified inclusion and exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
260 participants in 1 patient group
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Central trial contact
Moderna WeCare Team
Data sourced from clinicaltrials.gov
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