No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
6 Months and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Prevention
Participants needed
1,144 (estimated)
Sponsor
ModernaTX, Inc. · Industry
Who this trial is looking for
This trial is looking for adults who have been vaccinated against COVID-19. Participants will receive a new mRNA vaccine aimed at improving immunity to different variants of the virus.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old and have been vaccinated against COVID-19.
I am at least 6 months old and have at least one risk factor for severe COVID-19 outcomes.
I can follow the study procedures as decided by the Investigator.
I am a female of childbearing potential and have a negative pregnancy test.
I have used effective contraception for at least 28 days before my first dose.
You may not be able to join if
I had a COVID-19 infection in the last 3 to 6 months.
I am feeling ill or have a fever in the 3 days before the trial starts.
I have a history of a serious allergic reaction to mRNA vaccines.
I received a COVID-19 vaccine in the last 3 to 6 months.
I received a non-COVID-19 vaccine in the last 14 to 28 days.
I have taken immunosuppressive drugs for more than 14 days in the last 6 months.
I have donated blood products in the last 28 days.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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).
Trial Locations
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City
State
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Status
Eligibility Criteria
Key Inclusion Criteria:
* 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 year…
Key Inclusion Criteria:
* 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.
* 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 Criteria:
* 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.
* 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 and mRNA-1273.261.
* Receipt of any licensed non-COVID-19 vaccine within 14 days (inactivated vaccine, pediatric) or 28 days before or planned receipt within 14 days (pediatric) or 28 days after the study intervention, except an influenza vaccine, which may be given at least 7 days before (pediatric) or 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 and mRNA-1273.261) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
* Receipt of systemic immunoglobulins, long-acting biological therapies that affect immune (pediatric) responses, 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 and mRNA-1273.261) 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.
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