96 Participants NeededMy employer runs this trial

mRNA-1010 for Flu

Recruiting at 5 trial locations
MW
Overseen ByModerna WeCare Team
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new flu vaccine called mRNA-1010 in healthy children. Researchers aim to assess its safety, the body's response, and its potential effectiveness against the flu. The trial includes three groups: one receives a common flu vaccine, another receives a full dose of mRNA-1010, and the last group receives a low dose of mRNA-1010. Children who have not experienced major allergic reactions to vaccines and can adhere to the study rules are suitable candidates. As a Phase 1 trial, participants will be among the first to receive this new vaccine, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressants or certain other medications that affect the immune system, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown mRNA-1010 to be safe. Research indicates it does not increase the risk of serious side effects compared to regular flu vaccines. Most side effects were mild to moderate, such as soreness at the injection site or a mild fever, similar to other flu shots. No major safety concerns have emerged so far. Overall, the treatment appears well-tolerated based on the available data.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about mRNA-1010 for flu because it represents a novel approach to flu vaccination using mRNA technology. Unlike traditional vaccines like Fluarix Trivalent that use inactivated viruses to trigger an immune response, mRNA-1010 uses messenger RNA to instruct cells to produce proteins that mimic the flu virus, prompting the body to build immunity. This method has the potential for quicker updates to match circulating flu strains and faster production times, which could significantly improve the efficacy and responsiveness of flu vaccines. Additionally, the study explores both full and low dose options, potentially offering tailored protection with fewer side effects.

What evidence suggests that this trial's treatments could be effective for flu?

Research has shown that the mRNA-1010 flu vaccine appears promising based on early studies. In one study, an experimental mRNA flu vaccine was 100% effective in preventing both flu symptoms and fever, compared to 85% and 100% effectiveness with regular vaccines. Another study found that the mRNA-1010 vaccine reduced the risk of getting the flu by 26.6% more than standard vaccines. This trial will compare the mRNA-1010 vaccine, administered in either a full or low dose, with the Fluarix Trivalent vaccine. These results suggest that mRNA-1010 might offer better protection against the flu than traditional vaccines. While these findings are encouraging, they come from early studies, and more research is needed to confirm these results in different groups, including children.678910

Are You a Good Fit for This Trial?

This trial is for healthy children ages 9 to under 18 years old. Participants should not have major health problems or conditions that could interfere with the study.

Inclusion Criteria

I am between 9 and 17 years old.
I understand the study and am willing and able to follow all its requirements.
For female participants of childbearing potential: negative pregnancy test, adequate contraception or abstinence from activities that could result in pregnancy for at least 28 days prior to Day 1, and agreement to continue adequate contraception through 90 days following vaccine administration

Exclusion Criteria

History of a diagnosis or condition not specifically listed as exclusionary that is clinically unstable, potentially affects participant safety, assessment of study endpoints, immune response, or adherence to study procedures in the judgment of the Investigator
I have not had a fever or been acutely ill in the past 3 days.
Donated ≥450 mL of blood products within 28 days prior to the Screening Visit or plans to donate blood products within 28 days post study vaccine administration
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of either Fluarix Trivalent or mRNA-1010 by intramuscular injection on Day 1

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity, with seroconversion measured by HAI assay

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • mRNA-1010

Trial Overview

The study compares a new flu vaccine called mRNA-1010 to an existing flu vaccine, Fluarix Trivalent, in children. Researchers want to see how safe each vaccine is and how well they help the body build protection against the flu.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: mRNA-1010 Low DoseExperimental Treatment1 Intervention
Group II: mRNA-1010 Full DoseExperimental Treatment1 Intervention
Group III: Fluarix TrivalentActive 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

Citations

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Solicited adverse reactions occurred more often with mRNA-1010 than the standard-dose comparator; they were mainly mild-to-moderate and ...