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Virus Therapy
mRNA Vaccines for Flu and COVID-19
Phase 1 & 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
Are you 65–79 years of age?
In general, do you consider yourself to be in good health?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1), day 29, and day 181
Awards & highlights
Study Summary
This trial tests the safety, reactivity, and effectiveness of an mRNA-1083 vaccine for adults to see if it should be used widely.
Who is the study for?
This trial is for healthy adults aged 65–79 who've completed their initial COVID-19 vaccine series at least 4 months ago and haven't had a flu shot in the last 5 months. Participants must be willing to attend up to 5 visits and take about 4 calls over roughly 7 months.Check my eligibility
What is being tested?
The study tests several mRNA-based vaccines against influenza and COVID-19, including new formulations like mRNA-1283.222, to find the best composition and dose for future larger trials.See study design
What are the potential side effects?
Potential side effects may include typical reactions seen with vaccinations such as soreness at injection site, fatigue, headache, muscle pain, chills or fever. Each individual's reaction can vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1), day 29, and day 181
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1), day 29, and day 181
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 Solicited Local and Systemic Adverse Reactions (ARs)
Number of Participants With Unsocilited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation of Study
Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs
Secondary outcome measures
Change From Baseline in GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA
Change From Baseline in GMT of Antibodies for SARS-CoV-2, as Measured by Pseudovirus Neutralization Assay (PsVNA)
Change From Baseline in Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay
+3 moreTrial Design
24Treatment groups
Experimental Treatment
Active Control
Group I: Cohort B7: mRNA-1083.3Experimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1083.3 on Day 1.
Group II: Cohort B6: mRNA-1083.2 Dose CExperimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1083.2 at Dose Level C on Day 1.
Group III: Cohort B5: mRNA-1083.2 Dose BExperimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1083.2 at Dose Level B on Day 1.
Group IV: Cohort B4: mRNA-1083.2 Dose AExperimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1083.2 at Dose Level A on Day 1.
Group V: Cohort B3: mRNA-1083.1 Dose CExperimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1083.1 at Dose Level C on Day 1.
Group VI: Cohort B2: mRNA-1083.1 Dose BExperimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1083.1 at Dose Level B on Day 1.
Group VII: Cohort B1: mRNA-1083.1 Dose AExperimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1083.1 at Dose Level A on Day 1.
Group VIII: Cohort A7: mRNA-1083.3Experimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1083.3 on Day 1.
Group IX: Cohort A6: mRNA-1083.2 Dose CExperimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1083.2 at Dose Level C on Day 1.
Group X: Cohort A5: mRNA-1083.2 Dose BExperimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1083.2 at Dose Level B on Day 1.
Group XI: Cohort A4: mRNA-1083.2 Dose AExperimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1083.2 at Dose Level A on Day 1.
Group XII: Cohort A3: mRNA-1083.1 Dose CExperimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1083.1 at Dose Level C on Day 1.
Group XIII: Cohort A2: mRNA-1083.1 Dose BExperimental Treatment1 Intervention
Participants will receive single intramuscular (IM) injection of mRNA-1083.1 at Dose Level B on Day 1.
Group XIV: Cohort A12: FluarixActive Control1 Intervention
Participants will receive single IM injection of Fluarix on Day 1.
Group XV: Cohort B10: mRNA-1273.222Active Control1 Intervention
Participants will receive single IM injection of mRNA-1273.222 on Day 1.
Group XVI: Cohort B11: mRNA-1010Active Control1 Intervention
Participants will receive single IM injection of mRNA-1010 on Day 1.
Group XVII: Cohort A8: mRNA-1010.4Active Control1 Intervention
Participants will receive single IM injection of mRNA-1010.4 on Day 1.
Group XVIII: Cohort B8: mRNA-1010.4Active Control1 Intervention
Participants will receive single IM injection of mRNA-1010.4 on Day 1.
Group XIX: Cohort A9: mRNA-1283.222Active Control1 Intervention
Participants will receive single IM injection of mRNA-1283.222 on Day 1.
Group XX: Cohort A10: mRNA-1273.222Active Control1 Intervention
Participants will receive single IM injection of mRNA-1273.222 on Day 1.
Group XXI: Cohort A13: Fluzone HDActive Control1 Intervention
Participants will receive single IM injection of Fluzone HD on Day 1.
Group XXII: Cohort A11: mRNA-1010Active Control1 Intervention
Participants will receive single IM injection of mRNA-1010 on Day 1.
Group XXIII: Cohort B12: FluarixActive Control1 Intervention
Participants will receive single IM injection of Fluarix on Day 1.
Group XXIV: Cohort B9: mRNA-1283.222Active Control1 Intervention
Participants will receive single IM injection of mRNA-1283.222 on Day 1.
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
107 Previous Clinical Trials
61,376,894 Total Patients Enrolled
37 Trials studying COVID-19
61,259,335 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Would you be able and willing to participate in to up to 5 in-person visits and about 4 phone calls over a time period of up to 7 months?Are you 65–79 years of age?In general, do you consider yourself to be in good health?Have you completed the two-dose COVID-19 vaccine primary series?Have you not received a COVID-19 vaccine within the last 4 months?Have you not received a seasonal flu vaccine within the last 5 months?
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A3: mRNA-1083.1 Dose C
- Group 2: Cohort A4: mRNA-1083.2 Dose A
- Group 3: Cohort A12: Fluarix
- Group 4: Cohort B6: mRNA-1083.2 Dose C
- Group 5: Cohort A2: mRNA-1083.1 Dose B
- Group 6: Cohort A5: mRNA-1083.2 Dose B
- Group 7: Cohort A6: mRNA-1083.2 Dose C
- Group 8: Cohort B1: mRNA-1083.1 Dose A
- Group 9: Cohort B3: mRNA-1083.1 Dose C
- Group 10: Cohort A7: mRNA-1083.3
- Group 11: Cohort B10: mRNA-1273.222
- Group 12: Cohort B11: mRNA-1010
- Group 13: Cohort A8: mRNA-1010.4
- Group 14: Cohort B7: mRNA-1083.3
- Group 15: Cohort B8: mRNA-1010.4
- Group 16: Cohort A9: mRNA-1283.222
- Group 17: Cohort B2: mRNA-1083.1 Dose B
- Group 18: Cohort A10: mRNA-1273.222
- Group 19: Cohort A13: Fluzone HD
- Group 20: Cohort B4: mRNA-1083.2 Dose A
- Group 21: Cohort A11: mRNA-1010
- Group 22: Cohort B12: Fluarix
- Group 23: Cohort B5: mRNA-1083.2 Dose B
- Group 24: Cohort B9: mRNA-1283.222
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.
COVID-19 Patient Testimony for trial: Trial Name: NCT05827926 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research study open to seniors over 75 years of age?
"This research study is open to patients aged 18-79, with 71 studies for minors and 220 trials designed for seniors."
Answered by AI
How many volunteers have enrolled in this experiment?
"The study requires 1224 participants who satisfy the predetermined inclusion criteria. It is being conducted by ModernaTX, Inc., and will be hosted at sites such as Benchmark Research in Colton, California and Marvel Clinical Research in Huntington Beach, Colorado."
Answered by AI
Are there any local sites where this research endeavor is taking place?
"67 medical centres across the country are currently running this experiment, with locations spanning from Colton to Huntington Beach and Modesto. To reduce travel demands, it is recommended that participants select a nearby location when signing up."
Answered by AI
To whom does this experimental trial extend eligibility?
"This clinical trial seeks to accept 1224 patients who have contracted Covid-19 and are between 18 and 79 years of age."
Answered by AI
Are there any vacancies left to participate in this clinical investigation?
"According to the data hosted on clinicaltrials.gov, this medical trial is still in need of participants and recently updated its listing on April 24th 2023. The initial posting was made a little over a week earlier, on April 14th 2023."
Answered by AI
Who else is applying?
What state do they live in?
Nevada
Florida
Texas
Other
What site did they apply to?
Tekton Research
Benchmark Research
Cyfair Clinical Research
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2
0
What questions have other patients asked about this trial?
The trial pertains to Covid vaccines. Is that correct?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
To help research. i have long covid. I want to help out. Trying to make extra money.
PatientReceived 1 prior treatment
Part of other studies in the past.
PatientReceived 2+ prior treatments
How responsive is this trial?
Average response time
- < 1 Day
Typically responds via
Email
Most responsive sites:
- Tekton Research: < 24 hours
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