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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 29 (28 days after vaccination)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 29 (28 days after vaccination)
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
108 Previous Clinical Trials
61,379,047 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a severe allergic reaction after getting mRNA or influenza vaccines in the past.You have a history of weak immune system, immune-related disease, or frequent serious infections.You tested positive for the flu within the last 150 days before the study starts.You have taken certain medications that weaken your immune system for more than 14 days in the last 180 days, or you expect to need these medications during the study. You can use certain types of steroids, but not others.You have been in close contact with someone who has been diagnosed with the flu or has been treated with flu medication in the past 5 days before the start of the study.You don't know if you got a flu shot in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: mRNA-1010.6 Dose A
- Group 2: mRNA-1010 Dose C
- Group 3: mRNA-1010.4 Dose B
- Group 4: mRNA-1010.4 Dose C
- Group 5: mRNA-1010.6 Dose B
- Group 6: mRNA-1010.6 Dose C
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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