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Vaccine

mRNA Vaccines Comparison for COVID-19 Prevention (NextCOVE 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
Has previously received a primary series of an authorized/approved COVID-19 vaccine. For participants ≥18 years of age, at least 1 booster dose must have also been received. Proof of prior vaccination is required. A heterologous vaccine regimen is acceptable.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 29, 91, 181, and 365
Awards & highlights

NextCOVE Trial Summary

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

Who is the study for?
This trial is for people ≥12 years old who've had a full initial COVID-19 vaccination series, and if they're ≥18, at least one booster. They must show proof of vaccination, be able to follow the study plan, and not be pregnant or become pregnant during the study. People can't join if they've been exposed to COVID-19 recently, are sick or have a fever before starting the trial, have conditions that could risk their health in the study or affect results, plan to get other vaccines close to this trial's timeline, received certain treatments like blood products or immunosuppressants near the start of the trial.Check my eligibility
What is being tested?
The study compares two mRNA vaccines: mRNA-1283.222 (new) versus mRNA-1273.222 (existing). It looks at how safe they are and how bodies react to them ('reactogenicity'), as well as comparing their effectiveness ('relative vaccine efficacy') and immune response ('immunogenicity').See study design
What are the potential side effects?
While specific side effects aren't listed here, typical reactions may include pain at injection site, fatigue, headache, muscle pain, chills fever after getting vaccinated—commonly known as 'reactogenicity'. These usually last a short time.

NextCOVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have completed the initial COVID-19 vaccine series and, if over 18, received a booster.

NextCOVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 29, 91, 181, and 365
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 29, 91, 181, and 365 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Number of Participants with Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study, and AEs of Special Interest (AESIs)
+5 more
Secondary outcome measures
Geometric Mean Titers (GMTs) of Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G
Number of Participants with a SARS-CoV-2 Infection (Symptomatic or Asymptomatic)
SRR Against Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G

NextCOVE Trial Design

2Treatment groups
Experimental Treatment
Group I: mRNA-1283.222Experimental Treatment1 Intervention
Participants will receive single intramuscular (IM) injection of mRNA-1283.222 on Day 1.
Group II: mRNA-1273.222Experimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1273.222 on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1273.222
2021
Completed Phase 3
~6280

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
108 Previous Clinical Trials
61,368,442 Total Patients Enrolled
37 Trials studying COVID-19
61,249,095 Patients Enrolled for COVID-19

Media Library

mRNA-1273.222 (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05815498 — Phase 3
COVID-19 Research Study Groups: mRNA-1273.222, mRNA-1283.222
COVID-19 Clinical Trial 2023: mRNA-1273.222 Highlights & Side Effects. Trial Name: NCT05815498 — Phase 3
mRNA-1273.222 (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05815498 — Phase 3
COVID-19 Patient Testimony for trial: Trial Name: NCT05815498 — Phase 3

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Texas
California
Florida
Other
What site did they apply to?
Velocity Clinical Research Huntington Park
Anaheim Clinical Trials, LLC
Chemidox Clinical Trials
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+
0

What questions have other patients asked about this trial?

When is the screening period? Can we work around my work schedule?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I want to help. I care about public health. interested in this research. Want to help find end to covid.
PatientReceived no prior treatments
Want to know more about Covid.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 1 Day
Most responsive sites:
  1. CVS Health: < 24 hours
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
A Study of mRNA-1283.222 Injection Compared With mRNA-1273.222 Injection in Participants ≥12 Years of Age to Prevent COVID-19
2023. "A Study of mRNA-1283.222 Injection Compared With mRNA-1273.222 Injection in Participants ≥12 Years of Age to Prevent COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05815498.
All > Covid 19 > Meridian
~2151 spots leftby Aug 2024
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