mRNA-1403 for Stomach Flu

(Nova 301 Trial)

Recruiting at 286 trial locations

Overseen By Moderna Clinical Trials Support Center

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: ModernaTX, Inc.

Must not be taking: Immunosuppressants, Blood products

Disqualifiers: Chronic GI disease, Immunodeficiency, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1403, and to demonstrate the efficacy of mRNA-1403 to prevent protocol-defined moderate or severe norovirus acute gastroenteritis (AGE) associated with vaccine matched genotypes.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressive therapies or have received certain vaccines recently, you may need to discuss this with the study team.

Eligibility Criteria

This trial is for adults over 18 years old who want to prevent severe stomach flu caused by norovirus. Participants should be healthy with no recent history of gastroenteritis and not pregnant. They can't join if they've had a bad reaction to vaccines before or are on medications that affect the immune system.

Inclusion Criteria

I can sign the consent form and follow the study's requirements.

I understand the study requirements and can follow them on my own.

Participants may have chronic medical diagnoses but should be medically stable as assessed by the following criteria: Absence of medical events associated with underlying diagnoses and qualifying as SAEs within 1 month prior to study intervention on Day 1. Absence of known, current, and life-limiting diagnoses, which could continue for the duration of the study and which, in the opinion of the Investigator, would make completion of the protocol unlikely.

Exclusion Criteria

Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius (°C) [100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1.

History of a diagnosis or condition that in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.

Reported history of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine or intervention that includes one or more of the same components contained in the study vaccine.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single injection of mRNA-1403 or placebo on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• mRNA-1403 (Virus Therapy)

Trial Overview The study tests mRNA-1403, which is a new vaccine aimed at preventing acute gastroenteritis from norovirus. Some participants will receive the actual vaccine while others will get a placebo, and researchers will compare results between these two groups.

Participant Groups

Group I: mRNA-1403 Experimental Treatment 1 Intervention

Participants will receive a single injection of mRNA-1403 on Day 1.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive a single injection of mRNA-1403 matching placebo (0.9% sodium chloride solution) on Day 1.

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