Status:
RECRUITING
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Vaccine Formulations
Lead Sponsor:
ModernaTX, Inc.
Conditions:
SARS-CoV-2
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to investigate the immunogenicity of mRNA COVID-19 variant-containing vaccine formulations against the vaccine matched variants and newly emerged variants of severe acute ...
Detailed 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-1273 COVID-19 vaccine. As different varia...
Eligibility Criteria
Inclusion
- Key
- mRNA-1273.167 and mRNA-1273.712: Previously vaccinated adults aged ≥18 years
- mRNA-1273.251: Participants ≥65 years or ≥12 to \<65 years of age 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.
- Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:
- Has a negative pregnancy test at the Screening Visit and on the day of vaccination prior to vaccine dose being administered on Day 1.
- 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.
- Has agreed to continue adequate contraception through 28 days following vaccine administration.
- Key
Exclusion
- History of SARS-CoV-2 infection within 3 months prior to enrollment for mRNA-1273.167 and mRNA-1273.712 or within 6 months prior to enrollment for mRNA-1273.251.
- 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.
- Receipt of COVID-19 vaccine within 3 months prior to enrollment for mRNA-1273.167 and mRNA-1273.712 or within 6 months prior to enrollment for mRNA-1273.251.
- Receipt of any licensed non-COVID-19 vaccine within 28 days before or planned receipt within 28 days after the study intervention, except an influenza vaccine, which may be given 14 days before or after receipt of the study intervention.
- Receipt of systemic immunosuppressants or immune-modifying drugs for \>14 days total (within 6 months prior to Screening for mRNA-1273.167 and mRNA-1273.712 or within 180 days prior to Screening for mRNA-1273.251) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
- Receipt of systemic immunoglobulins or blood products (within 3 months prior to Screening for mRNA-1273.167 and mRNA-1273.712 or within 90 days prior to the Screening for mRNA-1273.251) or plans for receipt during the study.
- Has donated ≥450 milliliters of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.
- Other protocol defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
September 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 7 2026
Estimated Enrollment :
764 Patients enrolled
Trial Details
Trial ID
NCT06585241
Start Date
September 9 2024
End Date
May 7 2026
Last Update
October 23 2025
Active Locations (5)
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1
CenExel
Atlanta, Georgia, United States, 30331
2
CenExel
Decatur, Georgia, United States, 30030
3
Velocity Clinical Research
Baton Rouge, Louisiana, United States, 70809
4
Velocity Clinical Research
Gulfport, Mississippi, United States, 39503