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Virus Therapy
mRNA-1010 Vaccine for Flu
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 older than 18 years old
Must not have
Has received systemic immunosuppressants (for glucocorticoids ≥ 10 mg/day of prednisone or equivalent) for > 14 days in total within 180 days before vaccination visit (D1) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed.
Has received systemic immunoglobulins or long-acting biological therapies that may suppress or alter immune responses (for example, Infliximab®) or blood products within 90 days before the vaccination visit or plans to receive them during the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 57, 121, and 181
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new flu vaccine called mRNA-1010 to see if it is safe and effective for people who need flu shots. The new vaccine uses a small piece of genetic material to help the body recognize and fight the flu virus.
Who is the study for?
This trial is for healthy adults who can become pregnant but are not currently, using contraception or abstaining from pregnancy-causing activities. They must have a BMI of 18-<40 kg/m^2 (Part A only), no acute illness/fever before vaccination, and no history of severe allergies to mRNA or flu vaccines.
What is being tested?
The study tests the safety and immune response effectiveness of mRNA-1010 compared to other flu vaccines. Participants will be assessed on Day 29 for their body's defense against specific influenza strains.
What are the potential side effects?
Possible side effects include typical vaccine reactions like soreness at the injection site, fever, fatigue, headache, muscle pain. Severe allergic reactions are rare but possible in those with egg protein allergies.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have used strong immune system suppressants for more than 2 weeks in the last 6 months.
Select...
I have not received immune-altering drugs or blood products in the last 90 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 57, 121, and 181
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 57, 121, and 181
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part C: Percentage of Participants with Seroresponse at Day 29, as Measured by RSV Neutralization Assay
Parts A, B, and C: Percentage of Participants with Seroresponse at Day 29, as Measured by HAI Assay
Secondary study objectives
Part C: Percentage of Participants with Seroresponse at Days 57, 121, and 181, as Measured by HAI Assay
Part C: Percentage of Participants with Seroresponse at Days 57, 121, and 181, as Measured by RSV Neutralization Assay
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Active Control
Group I: Parts A and B - Arm 5: mRNA-1010 (Age Group 65-80 years)Experimental Treatment1 Intervention
Participants will receive a single dose of mRNA-1010 by IM injection on Day 1.
Group II: Parts A and B - Arm 1: mRNA-1010 (Age Group 18-50 years)Experimental Treatment1 Intervention
Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
Group III: Part C - Arm 3: mRNA-1045 (Age Group 18-50 years)Experimental Treatment1 Intervention
Participants will receive a single dose of mRNA-1045 by IM injection on Day 1.
Group IV: Part C - Arm 2: mRNA-1010 and mRNA-1345 (Age Group 18-50 years)Experimental Treatment2 Interventions
Participants will receive one dose of mRNA-1010 at Day 1 followed by one dose of mRNA-1345 in the contralateral arm at Day 29.
Group V: Part C - Arm 1: mRNA-1010 and mRNA-1345 (Age Group 18-50 years)Experimental Treatment2 Interventions
Participants will receive one dose of mRNA-1010 concomitantly injected with one dose of mRNA-1345 in the contralateral arm at Day 1.
Group VI: Parts A and B - Arm 2: Egg-based Quadrivalent Influenza Vaccine (Age Group 18-50 years)Active Control1 Intervention
Participants will receive a single dose of egg-based quadrivalent influenza vaccine by IM injection on Day 1.
Group VII: Parts A and B - Arm 3: Adjuvanted Quadrivalent Influenza Vaccine (Age Group 65-80 years)Active Control1 Intervention
Participants will receive a single dose of adjuvanted quadrivalent influenza vaccine by IM injection on Day 1.
Group VIII: Parts A and B - Arm 4: Inactivated Influenza Vaccine (Age Group 65-80 years)Active Control1 Intervention
Participants will receive a single dose of inactivated influenza vaccine by IM injection on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1345
2023
Completed Phase 3
~2560
mRNA-1010
2022
Completed Phase 3
~40020
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for influenza include antiviral medications and vaccines. Antiviral medications, such as oseltamivir and zanamivir, inhibit the neuraminidase enzyme, preventing the release of new viral particles from infected cells, thereby limiting the spread of the virus within the body.
Vaccines, including traditional inactivated vaccines and newer mRNA-based vaccines like mRNA-1010, work by introducing viral antigens to the immune system, prompting it to produce antibodies and memory cells that can recognize and fight the actual virus upon exposure. For influenza patients, these treatments are crucial as they can reduce the severity and duration of symptoms, prevent complications, and decrease the spread of the virus within the community.
Microarray Gene Expression Dataset Re-analysis Reveals Variability in Influenza Infection and Vaccination.Utility of influenza vaccination for oncology patients.
Microarray Gene Expression Dataset Re-analysis Reveals Variability in Influenza Infection and Vaccination.Utility of influenza vaccination for oncology patients.
Find a Location
Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
120 Previous Clinical Trials
61,587,884 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a serious allergic reaction in the past after getting an mRNA or flu vaccine, or any of the ingredients in those vaccines, like egg protein.I have used strong immune system suppressants for more than 2 weeks in the last 6 months.I am not pregnant, not breastfeeding, and will use birth control during and after the vaccine trial.I have not received immune-altering drugs or blood products in the last 90 days.You have a history of weak immune system or serious infections, unless certain immune conditions are well-managed and don't need strong medication.You have skin conditions like tattoos, psoriasis, or vitiligo on the area where the vaccine will be injected.In Part A of the study, your BMI needs to be between 18 and less than 40. There is no BMI requirement for Part B.
Research Study Groups:
This trial has the following groups:- Group 1: Parts A and B - Arm 1: mRNA-1010 (Age Group 18-50 years)
- Group 2: Parts A and B - Arm 2: Egg-based Quadrivalent Influenza Vaccine (Age Group 18-50 years)
- Group 3: Part C - Arm 2: mRNA-1010 and mRNA-1345 (Age Group 18-50 years)
- Group 4: Parts A and B - Arm 3: Adjuvanted Quadrivalent Influenza Vaccine (Age Group 65-80 years)
- Group 5: Parts A and B - Arm 4: Inactivated Influenza Vaccine (Age Group 65-80 years)
- Group 6: Parts A and B - Arm 5: mRNA-1010 (Age Group 65-80 years)
- Group 7: Part C - Arm 1: mRNA-1010 and mRNA-1345 (Age Group 18-50 years)
- Group 8: Part C - Arm 3: mRNA-1045 (Age Group 18-50 years)
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.