mRNA-1273.712 Vaccine for Healthy Subjects

Recruiting at 23 trial locations

Overseen By Moderna Clinical Trials Support Center

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: ModernaTX, Inc.

Must not be taking: Immunosuppressants, Immunoglobulins, others

Disqualifiers: Myocarditis, Pericarditis, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

1000 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to assess cardiac troponin I (cTnI) values in participants who received mRNA-1273.712 or placebo.

Eligibility Criteria

This trial is for healthy individuals aged 12 to 30 years. The specific eligibility criteria are not provided, but typically participants must meet certain health standards and cannot have conditions that would interfere with the study or pose a risk.

Inclusion Criteria

Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)

Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

I understand and can follow the study's requirements.

Exclusion Criteria

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

Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment

I have had Guillain-Barré syndrome in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either mRNA-1273.712 or placebo, followed by crossover to the other treatment after 28 days

8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for cardiac troponin I (cTnI) levels after receiving the vaccine or placebo

4 weeks

Treatment Details

Interventions

• mRNA-1273.712

Trial Overview The study is testing whether there's a change in cardiac troponin I levels after receiving either the mRNA-1273.712 vaccine or a placebo. Cardiac troponin I is an indicator of heart muscle injury.

Participant Groups

Group I: Sequence 2: Placebo then mRNA-1273.712 Experimental Treatment 2 Interventions

Participants will receive placebo followed by mRNA-1273.712 28 days later.

Group II: Sequence 1: mRNA-1273.712 then Placebo Experimental Treatment 2 Interventions

Participants will receive mRNA-1273.712 followed by placebo 28 days later.

Who Is Running the Clinical Trial?

ModernaTX, Inc.

Lead Sponsor

Trials

127

Recruited

66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris