Your session is about to expire
← Back to Search
Vaccine
mRNA-1010 Vaccine for Flu (IGNITE P303 Trial)
Phase 3
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
Part B: At least 18 and <65 years of age, at the time of signing the ICF.
Part A: At least 18 years of age inclusive, at the time of signing the informed consent form (ICF).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 28 (28 days after vaccination)
Awards & highlights
IGNITE P303 Trial Summary
This trial tests the safety and effectiveness of a new vaccine for flu A & B strains.
Who is the study for?
Adults who can follow the study plan, with women of childbearing age needing a negative pregnancy test and contraception. People aged 18+ for Part A, 18-64 for Part B, and 65+ for Part C can join. Those with recent immunosuppressants use, unstable conditions, immune deficiencies, severe allergies to mRNA or flu vaccines including egg protein, recent vaccinations or flu shots are excluded.Check my eligibility
What is being tested?
The trial is testing mRNA-1010 seasonal influenza vaccine against a standard licensed flu shot in three parts based on age groups. It aims to assess how well these vaccines work (immunogenicity) and their safety in adults.See study design
What are the potential side effects?
Potential side effects may include typical reactions at the injection site like pain and swelling, general symptoms such as fever or fatigue, allergic responses especially in those with sensitivities to vaccine components like egg protein.
IGNITE P303 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 64 years old.
Select...
I am 18 years or older and have signed the consent form.
Select...
I am 65 years old or older.
IGNITE P303 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 28 (28 days after vaccination)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 28 (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
Geometric Mean Titer (GMT) of Serum Antibody Level as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29
Number of Participants with Medically-Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
+2 moreSecondary outcome measures
Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay at Day 29
Percentage of Participants with HAI Titer of ≥1:40 at Day 29
Side effects data
From 2022 Phase 1 & 2 trial • 885 Patients • NCT0495657574%
Injection site pain
46%
Fatigue
42%
Headache
32%
Myalgia
26%
Injection site lymphadenopathy
24%
Arthralgia
18%
Chills
10%
COVID-19
8%
Vomiting
6%
Upper respiratory tract infection
6%
Sinusitis
6%
Urinary tract infection
4%
Rhinovirus infection
2%
Gastroenteritis
2%
Musculoskeletal chest pain
2%
Road traffic accident
2%
Muscle strain
2%
Hypertension
2%
Injection site erythema
2%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 Extension: mRNA-1010 6.25 ug
Phase 2 NH: mRNA-1010 25 ug
Phase 2 Extension: mRNA-1010 25 ug
Phase 2 Extension: mRNA-1010 12.5 ug
Phase 2 NH: mRNA-1010 100 ug
Phase 1/2: mRNA-1010 200 ug
Phase 2 NH: mRNA-1010 50 ug
Phase 1/2: mRNA-1010 50 ug
Phase 1/2: mRNA-1010 100 ug
Phase 2 NH: Afluria Quadrivalent 60 ug
Phase 2 Extension: Afluria Quadrivalent 60 ug
Phase 1/2: Placebo
IGNITE P303 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: mRNA-1010Experimental Treatment1 Intervention
Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
Group II: Licensed Quadrivalent Inactivated Seasonal Influenza VaccineActive Control1 Intervention
Participants will receive a single dose of licensed quadrivalent inactivated seasonal influenza vaccine by IM injection on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1010
2022
Completed Phase 3
~31590
Find a Location
Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
107 Previous Clinical Trials
61,369,725 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unsure if I've had the flu vaccine recently.I understand and can follow the study's requirements.I am between 18 and 64 years old.I have used strong immune system suppressants recently or might need them during the study.I am 18 years or older and have signed the consent form.I am 65 years old or older.I haven't had any vaccines within 28 days before or plan to within 28 days after starting the study treatment.You have tested positive for the flu within the specified time frame before the start of the study.I am not pregnant, using birth control, or have not been sexually active for 28 days.I have a history of immune system problems or frequent severe infections.You have had a serious allergic reaction to mRNA vaccines or any components of the vaccines.I've been in close contact with someone who has the flu or is being treated for it within the last 5 days.I have not donated more than 450mL of blood in the last 28 days and do not plan to donate during the study.I have received a flu shot within the last 5 or 6 months, depending on the trial part.
Research Study Groups:
This trial has the following groups:- Group 1: mRNA-1010
- Group 2: Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Flu Patient Testimony for trial: Trial Name: NCT05827978 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has mRNA-1010 received federal authorization for use?
"Extensive clinical data confirms that mRNA-1010 is a safe intervention, so it earned the maximum score of 3."
Answered by AI
To what extent is this clinical trial being implemented across various medical centers?
"The medical trial is enrolling patients from 61 distinct sites, including North Alabama Research Center LLC in Athens, Cullman Research Center in Cullman and Desert Clinical Research - CCT in Mesa."
Answered by AI
Is enrollment in this research project still open?
"Clinicaltrials.gov indicates that the trial in question, initially published on April 17th 2023, is no longer accepting participants at this time. That being said, there are still 127 other trials actively seeking volunteers."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
What site did they apply to?
North Alabama Research Center LLC
Foothills Research Center - CCT
Tekton Research - Austin - PPDS
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I like to help. I want to be apart of a clinical trial. To help further research and find better medicine for a better world and more healthy people.
PatientReceived no prior treatments
I was part of the RSV group and I think it’s important for people to help find drugs or vaccines to help others.
PatientReceived 2+ prior treatments
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger