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Vaccine

mRNA Vaccines for COVID-19

Phase 1
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 50–75 years of age?
In general, do you consider yourself to be in good health?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 29 (28 days post vaccination)
Awards & highlights

Study Summary

This trial looks at the safety & reactions of different combinations of flu, RSV & SARS-CoV-2 vaccines in healthy older people.

Eligible Conditions
  • COVID-19
  • Respiratory Syncytial Virus
  • Influenza

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are between 50 and 75 years old.
Select...
Do you think you are generally healthy?
Select...
You must have received your COVID-19 vaccine at least four months ago, including any booster shots.
Select...
You have not gotten a flu shot in the past 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 29 (28 days post vaccination)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 29 (28 days post 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 AEs Leading to Discontinuation
Number of Participants with Adverse Events of Special Interest (AESIs)
Number of Participants with Medically-Attended AEs (MAAEs)
+3 more
Secondary outcome measures
Change From Baseline in GMFR as Measured by Microneutralization Assay at Day 29
Change From Baseline in GMFR as Measured by PsVNA (or Binding Antibody Assay) at Day 29
Change From Baseline in GMT as Measured by Microneutralization Assay at Day 29
+6 more

Trial Design

9Treatment groups
Experimental Treatment
Group I: mRNA-1345Experimental Treatment1 Intervention
Participants will receive a dose of mRNA-1345 by IM injection on Day 1.
Group II: mRNA-1273.214Experimental Treatment1 Intervention
Participants will receive a dose of mRNA-1273.214 by IM injection on Day 1.
Group III: mRNA-1230 Dose Level CExperimental Treatment1 Intervention
Participants will receive mRNA-1230 at Dose Level C by IM injection on Day 1.
Group IV: mRNA-1230 Dose Level BExperimental Treatment1 Intervention
Participants will receive mRNA-1230 at Dose Level B by IM injection on Day 1.
Group V: mRNA-1230 Dose Level AExperimental Treatment1 Intervention
Participants will receive mRNA-1230 at Dose Level A by IM injection on Day 1.
Group VI: mRNA-1045 Dose Level CExperimental Treatment1 Intervention
Participants will receive mRNA-1045 at Dose Level C by IM injection on Day 1.
Group VII: mRNA-1045 Dose Level BExperimental Treatment1 Intervention
Participants will receive mRNA-1045 at Dose Level B by IM injection on Day 1.
Group VIII: mRNA-1045 Dose Level AExperimental Treatment1 Intervention
Participants will receive mRNA-1045 at Dose Level A by IM injection on Day 1.
Group IX: mRNA-1010Experimental Treatment1 Intervention
Participants will receive a 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-1273.214
2021
Completed Phase 3
~8970
mRNA-1010
2022
Completed Phase 3
~31660

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
105 Previous Clinical Trials
61,372,852 Total Patients Enrolled
35 Trials studying COVID-19
61,255,333 Patients Enrolled for COVID-19

Media Library

mRNA-1010 (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05585632 — Phase 1
COVID-19 Research Study Groups: mRNA-1230 Dose Level A, mRNA-1045 Dose Level B, mRNA-1045 Dose Level C, mRNA-1273.214, mRNA-1230 Dose Level C, mRNA-1345, mRNA-1230 Dose Level B, mRNA-1010, mRNA-1045 Dose Level A
COVID-19 Clinical Trial 2023: mRNA-1010 Highlights & Side Effects. Trial Name: NCT05585632 — Phase 1
mRNA-1010 (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05585632 — Phase 1
COVID-19 Patient Testimony for trial: Trial Name: NCT05585632 — Phase 1

Frequently Asked Questions

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

Is there an opportunity to enroll in the experiment at this time?

"Clinicialtrials.gov's records show that this trial is actively seeking participants, with the original post date of October 14th 2022 and a most recent update on the same day."

Answered by AI

What is the total number of research facilities running this clinical investigation?

"Velocity Clinical Research in Anderson, South carolina; Family Practice of West Volusia, P.A. in DeLand Georgia and Southeast Regional Research Group in Columbus Texas are amongst the sites participating this clinical trial as well as an additional 9 locations."

Answered by AI

Has the FDA provided authorization for administration of mRNA-1045 Dose Level B?

"The safety of mRNA-1045 Dose Level B was assigned a score of 1 due to this being Phase I trial with limited clinical evidence regarding efficacy and safety."

Answered by AI

Who is eligible to partake in this research?

"This research project is currently recruiting 675 adults afflicted with influenza, aged between 50 and 75. To qualify for the program, participants must be capable of fulfilling all mandated follow-up protocols; they need to have a body mass index ranging from 18–35 kg/m2; non-pregnant female volunteers are obligated to abstain from any activity that may lead to pregnancy or use some form of contraception over the course of four months; additionally, applicants should have received at least one dose (primary series or booster) of an authorized vaccine against COVID-19 more than 120 days prior to Day 1 (or less per local guidance"

Answered by AI

Does this medical trial include individuals aged 75 and above?

"This clinical trial seeks participants aged 50 and above, yet below the age of 75."

Answered by AI

What is the population size of this research initiative?

"This clinical trial necessitates 675 participants that meet the inclusion criteria. Those interested in joining can do so from either Velocity Clinical Research located in Anderson, South carolina or Family Practice of West Volusia P.A., which is situated in DeLand, Georgia."

Answered by AI

Who else is applying?

What state do they live in?
Other
Texas
Georgia
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
2
1
0
What site did they apply to?
Atlanta Center for Medical Research - Family Medicine
DM Clinical Research
Research Centers of America (cenexel)
Other

Why did patients apply to this trial?

Need to help science. To improve myself and compensation. I want to be a part of the solution.
PatientReceived no prior treatments
It's a way of giving back to help people. Want to be totally defensive against Cobid.
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. Research Centers of America (cenexel): < 24 hours
  2. DM Clinical Research: < 24 hours
  3. Atlanta Center for Medical Research - Family Medicine: < 24 hours
Typically responds via
Phone Call
Email
Average response time
  • < 2 Days
~162 spots leftby Mar 2025