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mRNA-1283.222 for COVID-19

Lynn Institute of the Ozarks, Little Rock, AR
COVID-19+7 More ConditionsmRNA-1283.222 - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

This trial tests the safety and effectiveness of two different mRNA vaccines to prevent COVID-19.

Eligible Conditions
  • COVID-19
  • COVID-19 (coronavirus disease 2019)
  • Coronavirus
  • Mild-to-Moderate COVID-19

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

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mRNA-1045 Dose Level B
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Study Objectives

7 Primary · 4 Secondary · Reporting Duration: Days 29, 91, 181, and 365

Day 365
Number of Participants with Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study, and AEs of Special Interest (AESIs)
Day 29
GMR of the Ancestral SARS-CoV-2 D614G mRNA-1283.222 Over the Ancestral SARS-CoV-2 D614G mRNA-1273.222 After the Booster Dose
Geometric Mean Ratio (GMR) of Omicron BA.4/5 mRNA-1283.222 Over the Omicron BA.4/5 mRNA-1273.222 After the Booster Dose
SRR Difference of Ancestral SARS-CoV-2 D641G Between mRNA-1283.222 and mRNA-1273.222 After the Booster Dose
Seroresponse Rate (SRR) Difference of Omicron BA.4/5 Between mRNA-1283.222 and mRNA-1273.222 After the Booster Dose
Day 29
SRR Against Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G
Day 91
Geometric Mean Titers (GMTs) of Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G
Day 365
Number of Participants with a SARS-CoV-2 Infection (Symptomatic or Asymptomatic)
rVE of mRNA-1283.222 and mRNA-1273.222 to Prevent the First Event of COVID-19
Day 28
Number of Participants with Unsolicited Adverse Events (AEs)
Day 7
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
mRNA-1045 Dose Level B
1
mRNA-1273
2
mRNA-1273

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

mRNA-1283.222
1 of 2
mRNA-1273.222
1 of 2

Experimental Treatment

8472 Total Participants · 2 Treatment Groups

Primary Treatment: mRNA-1283.222 · No Placebo Group · Phase 3

mRNA-1283.222
Biological
Experimental Group · 1 Intervention: mRNA-1283.222 · Intervention Types: Biological
mRNA-1273.222
Biological
Experimental Group · 1 Intervention: mRNA-1273.222 · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: days 29, 91, 181, and 365

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
80 Previous Clinical Trials
50,295,592 Total Patients Enrolled
28 Trials studying COVID-19
50,199,614 Patients Enrolled for COVID-19

Eligibility Criteria

Age Any Age · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
California33.3%
Nevada33.3%
Massachusetts33.3%
What site did they apply to?
DM Clinical Research50.0%
Las Vegas Clinical Trials50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "Want to help find end to covid"
How many prior treatments have patients received?
0100.0%
References

Frequently Asked Questions

Does the research being conducted span a broad swath of North America?

"This clinical trial is being run in over 200 locations, including Huntsville, Chandler and Phoenix. To reduce any travel burdens involved with participation, it may be best to select the medical centre closest to you." - Anonymous Online Contributor

Unverified Answer

What adverse effects have been reported from using mRNA-1283.222?

"Our team at Power has rated the safety of mRNA-1283.222 a 3 on account of this Phase 3 trial's extensive background in efficacy and multiple data sets confirming its security." - Anonymous Online Contributor

Unverified Answer

How many volunteers have enrolled in this research endeavor?

"8472 eligible candidates will be needed to partake in this medical study, with Optimal Research in Huntsville and Chandler Clinical Trials in Chandler both having open enrollment." - Anonymous Online Contributor

Unverified Answer

Is the study currently enrolling new participants?

"Affirmative, the information available on clinicaltrials.gov indicates that this experiment is actively recruiting patients. This study was launched on March 28th 2023 and has most recently been updated April 13th of the same year. 8472 participants are needed to be recruited from 209 separate centres." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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