A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Vaccine Formulations
ConditionSARS-CoV-2
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6+
SponsorModernaTX, Inc.
About this trial
The purpose of this study is to investigate the immunogenicity and safety of mRNA COVID-19 variant-containing vaccine formulations against the vaccine-matched variants and newly emerged variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Eligibility criteria
Qualifiers
mRNA-1273.167 and mRNA-1273.712: Previously vaccinated adults aged ≥18 years
mRNA-1273.251: Participants ≥65 years of age, ≥12 to <65 years of age, or ≥6 months to <12 years of age with at least 1 risk factor for severe outcomes from COVID-19.
mRNA-1273.261: ≥65 years of age at the time of signing the informed consent or ≥18 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.
Able to comply with study procedures based on the assessment of the Investigator.
Disqualifiers
History of SARS-CoV-2 infection within 3 months prior to enrollment for mRNA-1273.167 and mRNA-1273.712 or within up to 6 months prior to enrollment for mRNA-1273.251 and mRNA-1273.261.
Is acutely ill or febrile (temperature 38.0°Celsius/100.4°Fahrenheit) less than 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the Screening window.
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.
History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic.
Trial design
Treatments tested in this trial
- mRNA-1273 Variant-containing Formulation
Treatment groups
1,144 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov