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mRNA Vaccine

mRNA Vaccines for COVID-19

Phase 2
Waitlist Available
Research Sponsored by ModernaTX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 29 (28 days after vaccination)
Awards & highlights

Study Summary

This trial will test how safe and effective a potential vaccine is for fighting COVID-19.

Who is the study for?
Healthy adults who can follow the study plan, have not had a flu shot or any vaccine within certain time frames before the trial, and show no severe allergies to mRNA vaccines. Women must test negative for pregnancy and use contraception. People with unstable health conditions or recent close contact with influenza cases are excluded.Check my eligibility
What is being tested?
The trial is testing different versions of an mRNA-based flu vaccine called mRNA-1010 (including variations like mRNA-1010.4 and mRNA-1010.6) to see how safe they are, how people react to them, and how well they work at triggering an immune response.See study design
What are the potential side effects?
Possible side effects may include typical reactions seen with vaccines such as pain at the injection site, fever, fatigue, headache, muscle pain, chills or joint pain. Severe allergic reactions are rare but could occur.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 29 (28 days after vaccination)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 29 (28 days after vaccination) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Discontinuation
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Number of Participants with Unsolicited Adverse Events (AEs)
Secondary outcome measures
Change from Baseline in Geometric Mean Fold Rise (GMFR) of Postinjection/Baseline, as Measured by HAI Assay
Change from Baseline in Geometric Mean Titer (GMT), as Measured by Hemagglutinin Inhibition (HAI) Assay
Percentage of Participants with Seroresponse for mRNA-1010, as Measured by HAI Assay

Trial Design

6Treatment groups
Experimental Treatment
Group I: mRNA-1010.6 Dose CExperimental Treatment1 Intervention
Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1.
Group II: mRNA-1010.6 Dose BExperimental Treatment1 Intervention
Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1.
Group III: mRNA-1010.6 Dose AExperimental Treatment1 Intervention
Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1.
Group IV: mRNA-1010.4 Dose CExperimental Treatment1 Intervention
Participants will receive a single dose of mRNA-1010.4 by IM injection on Day 1.
Group V: mRNA-1010.4 Dose BExperimental Treatment1 Intervention
Participants will receive a single dose of mRNA-1010.4 by IM injection on Day 1.
Group VI: mRNA-1010 Dose CExperimental Treatment1 Intervention
Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1010.6
2023
Completed Phase 2
~270
mRNA-1010
2022
Completed Phase 3
~31590
mRNA-1010.4
2023
Completed Phase 2
~270

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
106 Previous Clinical Trials
61,376,716 Total Patients Enrolled

Media Library

mRNA-1010 (mRNA Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05868382 — Phase 2
Influenza Research Study Groups: mRNA-1010.6 Dose A, mRNA-1010 Dose C, mRNA-1010.4 Dose B, mRNA-1010.4 Dose C, mRNA-1010.6 Dose B, mRNA-1010.6 Dose C
Influenza Clinical Trial 2023: mRNA-1010 Highlights & Side Effects. Trial Name: NCT05868382 — Phase 2
mRNA-1010 (mRNA Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05868382 — Phase 2
Influenza Patient Testimony for trial: Trial Name: NCT05868382 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to enroll in this medical experiment?

"Eligibility requirements for this clinical trial stipulate that participants should be between 18 and 49 years old, suffering from influenza. Approximately 270 patients are needed to complete this research project."

Answered by AI

To what extent has this experiment been implemented in hospitals around the country?

"Currently this experiment is running in 10 different cities, such as Miami, Lenexa and Rockville. It's important to select the nearest location for enrolment so that travelling requirements can be reduced."

Answered by AI

Is the age requirement for this research study higher than 80 years old?

"In adherence to the study's inclusion criteria, prospective participants must be between 18-49 years of age."

Answered by AI

Are there any opportunities to join this research project currently available?

"Affirmative. According to records hosted on clinicaltrials.gov, this investigation is currently enrolling patients which was first listed on the 15th of May 2023 and most recently updated 11 days later. A total number of 270 participants from 10 sites are needed for the trial."

Answered by AI

Has the FDA sanctioned the administration of mRNA-1010 Dose C as a viable treatment?

"As mRNA-1010 Dose C is in Phase 2 of its clinical trials, there are studies that indicate some degree of safety but no data proving efficacy. Thus, our team at Power rated the medication's safety as a 2 out of 3 on their scale."

Answered by AI

How many participants are being recruited for the experiment?

"Affirmative. Per the clinicaltrials.gov data, this research venture is currently accepting enrollees. The investigation was initially posted on May 15th 2023 and modified most recently on May 11th 2023 with a goal of enrolling 270 patients across 10 sites."

Answered by AI

Who else is applying?

What state do they live in?
Florida
New York
What site did they apply to?
Suncoast Research Group
United Medical Associates
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I love science, and thats for sure can save so much more lives in the future.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long does this trial goes?
PatientReceived 1 prior treatment
~141 spots leftby Apr 2025