mRNA-1018-H5 Vaccine for Flu

Recruiting at 35 trial locations

Overseen By Moderna WeCare Team

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: ModernaTX, Inc.

Must not be taking: Antivirals, Immunosuppressants, Corticosteroids, others

Disqualifiers: Myocarditis, Guillain-Barre, Immunodeficiency, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 2

Duration: 3 weeks

4000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate humoral immunogenicity after 2 doses of mRNA-1018-H5, and to evaluate the safety and reactogenicity of mRNA-1018-H5 in adults ≥18 years of age.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am not pregnant or breastfeeding and have a recent negative pregnancy test.

Participants must be healthy as determined by medical evaluation including medical history and physical examination. Participants with clinically stable chronic medical conditions are permitted.

Exclusion Criteria

I have taken immune-suppressing medicines in the past 6 months or plan to during the study.

I have had inflammation of my heart or the lining around my heart.

I have a history of immune system problems or frequent severe infections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mRNA-1018-H5 vaccine or placebo by intramuscular injection on Day 1 and Day 22

3 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and immunogenicity, with primary outcome measured at Day 43

6 months

Multiple visits (in-person and/or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• mRNA-1018-H5

How Is the Trial Designed?

Group I: mRNA-1018-H5 Vaccine Experimental Treatment 1 Intervention

Participants will receive mRNA-1018-H5 vaccine by intramuscular (IM) injection on Day 1 and Day 22.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo matched to mRNA-1018-H5 vaccine by IM injection on Day 1 and Day 22.

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