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A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Formulations

ConditionSARS-CoV-2
Trial statusNot yet recruiting
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 mRNA-1283 and mRNA-1273 (variant formulations) within the current epidemiological environment

Eligibility criteria

This trial accepts healthy volunteers

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.

Female participants of childbearing potential may be enrolled in the study if not pregnant or breastfeeding, subject to other criteria specified in the study protocol.

Disqualifiers

History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 6 months prior to enrollment.

Acutely ill or febrile within 72 hours prior to or at Day 1.

History of a diagnosis or conditions that in the Investigator's opinion could affect participant's safety, assessment of endpoints, assessment of immune response, or adherence to study procedures.

Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections.

Trial design

Design model

Parallel

Treatments tested in this trial

  • mRNA-1273

    Biological/Vaccine

    Sterile liquid for injection

  • mRNA-1283

    Biological/Vaccine

    Sterile liquid for injection

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: mRNA-1273 (Variant Formulation)Experimental treatment 1 intervention
Group B: mRNA-1283 (Variant Formulation)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Geometric Mean Titer (GMT) on Neutralizing Antibody (nAb) Against Vaccine-matched Variant Formulation

Time frame
Day 29
2

Geometric Mean Fold Rise (GMFR) on Neutralizing Antibody (nAb) Against Vaccine-matched Variant Formulation

Time frame
Day 29

Secondary outcomes

1

Number of Participants with Unsolicited Adverse Events (AEs)

Time frame
Day 1 through Day 29
2

Number of Participants with Serious AEs (SAEs), AEs Leading to Study Withdrawal, and AEs of Special Interest (AESIs)

Time frame
Day 1 through Day 29/End of Study (EOS)

Other outcomes

Sponsors and contacts

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

ModernaTX, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: