mRNA-1345 Vaccine for Respiratory Syncytial Virus

Recruiting at374 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: ModernaTX, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new vaccine called mRNA-1345 to see if it can prevent lung infections caused by the RSV virus. The vaccine works by teaching the body to recognize and fight the virus. The study will include people who are at risk of these infections and will compare the effects of the vaccine to a non-treatment group.

Research Team

Eligibility Criteria

This trial is for adults aged 60 and older who are generally healthy, can care for themselves, and may have stable chronic conditions like heart failure or lung disease. They must not have had severe vaccine reactions before, should not be undergoing changes in medical therapy, nor have life-limiting diagnoses that could prevent them from completing the study.

Inclusion Criteria

I have a history of chronic heart failure or COPD.

I am 80 or older, can care for myself, and my chronic conditions are stable.

You do not have any immune system disorders or defects from birth.

Treatment Details

Interventions

• mRNA-1345 Vaccine (Virus Therapy)

Trial Overview The trial is testing mRNA-1345 vaccine's safety and its ability to prevent serious lung infections caused by RSV compared to a placebo. Participants will receive one dose of either the vaccine or placebo and will be monitored for up to 12 months post-injection.

Participant Groups

Group I: mRNA-1345 BD Experimental Treatment 1 Intervention

Single injection of mRNA-1345 on BD Day 1.

Group II: mRNA-1345 Experimental Treatment 1 Intervention

Single injection of mRNA-1345 on Day 1.

Group III: Placebo Experimental Treatment 1 Intervention

Single injection of mRNA-1345 matching-placebo 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