A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Formulations
ConditionCOVID-19
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age12+
SponsorModernaTX, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
≥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.
Disqualifiers
History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 6 months prior to enrollment.
Acutely ill or febrile (temperature ≥38.0°Celsius/≥100.4°Fahrenheit) within 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the Screening window and will retain their initially assigned participant number.
History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.
Receipt of the COVID-19 vaccine within 6 months prior to enrollment.
Trial design
Treatments tested in this trial
- mRNA-1283.251 Variant-containing Formulation
Treatment groups
832 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov