Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • mRNA-1273 Variant-containing Formulation

    Biological/Vaccine

    Sterile liquid for injection

Treatment groups

1,144 Participants
are divided into 1 treatment group
Group A: mRNA-1273 Variant-containing FormulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

mRNA-1273.167, mRNA-1273.712, mRNA-1273.251, and mRNA-1273.261: Geometric Mean Value of Neutralizing Antibody Against COVID-19 Variants

Time frame
Up to Day 29
2

mRNA-1273.167, mRNA-1273.712, mRNA-1273.251, and mRNA-1273.261: Geometric Mean Fold Rise of Neutralizing Antibody Against COVID-19 Variants

Time frame
Up to 28 days after last dose of study intervention
3

mRNA-1273.251 and mRNA-1273.261: Seroresponse Rate

Time frame
Up to Day 29

Secondary outcomes

1

mRNA-1273.251: Geometric Mean Titer of Neutralizing Antibody Against COVID-19 Variants of Participants ≥12 to <65 Years Old and ≥65 Years Old

Time frame
Day 29
2

mRNA-1273.167, mRNA-1273.712, mRNA-1273.251, and mRNA-1273.261: Number of Participants with Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Study Withdrawal, and AEs of Special Interest

Time frame
Day 1 through end of study (up to Day 209)
3

mRNA-1273.251: Number of Participants with Solicited Local and Systemic Adverse Reactions

Time frame
Day 1 through 7 days after last dose of study intervention
4

mRNA-1273.251 and mRNA-1273.261: Number of Participants with Unsolicited AEs

Time frame
Day 1 through 28 days after last dose of study intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ModernaTX, Inc.

Lead sponsor

Source ClinicalTrials.gov
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