mRNA-1283 for COVID-19

Not yet recruiting at 30 trial locations
MW
Overseen ByModerna WeCare Team
Age: < 18
Sex: Any
Trial Phase: Phase 2
Sponsor: ModernaTX, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will evaluate 2 dose levels of mRNA-1283 in participants ≥6 months to \<12 years to determine the optimal dose level per age group.

Are You a Good Fit for This Trial?

This trial is for children ages 6 months to under 12 years who are generally healthy and want to participate in research on COVID-19 vaccines. Children with certain health conditions or recent vaccinations may not be able to join.

Inclusion Criteria

Participant is in good general health as determined by medical evaluation including medical history and physical examination; participants with chronic but stable conditions may be eligible if well-controlled and not expected to interfere with study participation or outcomes
For participants in Cohort 2: participant was born at ≥37 weeks, with a minimum birth weight of 2.5 kilograms, without fetal growth restriction
I am not pregnant or breastfeeding and use effective birth control as required by the study.
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Exclusion Criteria

I have taken immune-suppressing medicines in the past 6 months.
Child placed under control or protection of an agency, organization, institution, or entity by courts or government, excluding adopted children or those with appointed legal guardians
Participation in an interventional clinical study within 28 days prior to screening or plans to do so during study
See 9 more

What Are the Treatments Tested in This Trial?

Interventions

  • mRNA-1273
  • mRNA-1283

Trial Overview

The study is testing two different doses of a new COVID-19 vaccine (mRNA-1283) compared to an existing one (mRNA-1273) in young children, aiming to find the best dose that works safely and effectively.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Active Control

Group I: Cohort 2: mRNA-1283 Dose Level 2Experimental Treatment1 Intervention
Group II: Cohort 2: mRNA-1283 Dose Level 1Experimental Treatment1 Intervention
Group III: Cohort 1: mRNA-1283 Dose Level 2Experimental Treatment1 Intervention
Group IV: Cohort 1: mRNA-1283 Dose Level 1Experimental Treatment1 Intervention
Group V: Cohort 1: mRNA-1273Active Control1 Intervention
Group VI: Cohort 2: mRNA-1273Active Control1 Intervention

Find a Clinic Near You

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 profile image

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

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