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Virus Therapy

Group 3: mRNA-1083 Lot C for COVID-19

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
1. Investigator assessment that the participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.
2. Participants of nonchildbearing potential may be enrolled in the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 28 (28 days after vaccination)
Awards & highlights

Summary

The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity in relation to the product attributes of mRNA-1083 vaccine when administered as a single intramuscular (IM) injection in adults ≥50 to \<65 years of age.

Who is the study for?
This clinical trial is for adults aged between 50 and 65 who are in good health. The study aims to test a new vaccine targeting COVID-19 and the flu.
What is being tested?
The trial is testing mRNA-1083, a combined vaccine for SARS-CoV-2 (the virus that causes COVID-19) and influenza. Participants will receive one intramuscular injection of the vaccine.
What are the potential side effects?
Potential side effects may include typical reactions at the injection site like pain or swelling, general feelings of being unwell such as fever or fatigue, muscle pain, headache, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 28 (28 days after vaccination)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 28 (28 days after vaccination) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Geometric Mean Value of Antibodies at Day 29, as Measured by Hemagglutinin Inhibition (HAI) Assay for Influenza
Geometric Mean Value of Antibodies at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA) for SARS-CoV-2
Number of Participants with AEs Leading to Discontinuation from Study Participation
+5 more
Secondary study objectives
GMFR of Antibodies at Day 29 Relative to Day 1, as Measured by PsVNA for SARS-CoV-2
Geometric Mean Fold Rise (GMFR) of Antibodies at Day 29 Relative to Day 1, as Measured by HAI Assay for Influenza
Seroconversion Rate (SCR) in Anti-hemagglutinin (HA) Antibody Values at Day 29, as Measured by HAI Assay for Influenza
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group 4: mRNA-1083 Lot DExperimental Treatment1 Intervention
Participants will receive mRNA-1083 Lot D as a single injection on Day 1.
Group II: Group 3: mRNA-1083 Lot CExperimental Treatment1 Intervention
Participants will receive mRNA-1083 Lot C as a single injection on Day 1.
Group III: Group 2: mRNA-1083 Lot BExperimental Treatment1 Intervention
Participants will receive mRNA-1083 Lot B as a single injection on Day 1.
Group IV: Group 1: mRNA-1083 Lot AExperimental Treatment1 Intervention
Participants will receive mRNA-1083 Lot A as a single injection on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1083
2023
Completed Phase 3
~8080

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
110 Previous Clinical Trials
61,380,064 Total Patients Enrolled
38 Trials studying COVID-19
61,260,581 Patients Enrolled for COVID-19
~413 spots leftby Feb 2025
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