← Back to Search

Vaccine

mRNA-1073 for 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 29 (28 days post vaccination)

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of different combinations of three vaccines given to healthy adults.

Eligible Conditions

Influenza
COVID-19

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 29 (28 days post vaccination)

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 Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation

Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs)

Number of Participants With Unsolicited Adverse Events (AEs)

Secondary outcome measures

Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains

Geometric Mean Fold Rise of VAC62 Neutralizing Antibody at Day 29, as Measured by Pseudovirus Neutralization Assay (or Binding Antibody Assay) For SARS-CoV-2

Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains

+3 more

Side effects data

From 2022 Phase 1 & 2 trial • 550 Patients • NCT05375838

88%

Injection site pain

78%

Fatigue

72%

Myalgia

63%

Headache

50%

Chills

49%

Arthralgia

25%

Injection site lymphadenopathy

23%

Vomiting

20%

Pyrexia

11%

COVID-19

Rhinovirus infection

Injection site induration

Injection site erythema

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

mRNA-1273 + Placebo

Dose A: mRNA-1073 Low Dose + Placebo

mRNA-1010 + Placebo

mRNA-1010 + mRNA-1273

Dose B: mRNA-1073 Medium Dose + Placebo

Dose C: mRNA-1073 High Dose + Placebo

Trial Design

6Treatment groups

Experimental Treatment

Group I: mRNA-1273 Plus PlaceboExperimental Treatment2 Interventions

Participants will receive 2 intramuscular (IM) injections, one in each arm, of mRNA-1273 plus placebo at the specified dose level on Day 1.

Group II: mRNA-1010 Plus mRNA-1273Experimental Treatment1 Intervention

Participants will receive 2 IM injections, one in each arm, of mRNA-1010 plus mRNA-1273 at the specified dose level on Day 1.

Group III: mRNA-1010 Plus PlaceboExperimental Treatment2 Interventions

Participants will receive 2 IM injections, one in each arm, of mRNA-1010 plus placebo at the specified dose level on Day 1.

Group IV: Dose C: mRNA-1073 Plus PlaceboExperimental Treatment2 Interventions

Participants will receive 2 IM injections, one in each arm, of mRNA-1073 plus placebo at the specified dose level on Day 1.

Group V: Dose B: mRNA-1073 Plus PlaceboExperimental Treatment2 Interventions

Participants will receive 2 IM injections, one in each arm, of mRNA-1073 plus placebo at the specified dose level on Day 1.

Group VI: Dose A: mRNA-1073 Plus PlaceboExperimental Treatment2 Interventions

Participants will receive 2 IM injections, one in each arm, of mRNA-1073 plus placebo at the specified dose level on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Moderna COVID-19 Vaccine

FDA approved

mRNA-1073

2022

Completed Phase 2

~550

mRNA-1010

2022

Completed Phase 3

~31590

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor

108 Previous Clinical Trials

61,378,767 Total Patients Enrolled

37 Trials studying COVID-19

61,260,016 Patients Enrolled for COVID-19

Frequently Asked Questions

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

Am I eligible to partake in this research endeavor?

"This medical research is currently enrolling 550 individuals aged between 18 to 75 that have been diagnosed with COVID-19. Additionally, the potential participants must meet all of the following requirements: BMI in a range from 18 kg/m^2 to 35 kg/m^2 at screening, full vaccination for COVID-19 primary series as per local regulations and last vaccine administration had taken place no less than 120 days prior to randomization visit (or more if recommended by local authorities)."

Answered by AI

Is this experiment currently enrolling participants?

"Clinicaltrials.gov reveals that this medical trial, initially uploaded on May 13th 2022 and most recently edited October 5th of the same year, is not accepting any new participants at present. However, there are still 1132 other trials actively searching for candidates."

Answered by AI

Are seniors able to join the current clinical trial?

"According to the stipulations of this research study, potential participants must be aged 18 or higher and no more than 75 years old."

Answered by AI

How many health care facilities are facilitating this clinical trial?

"This medical experiment is currently recruiting from 13 different healthcare facilities. These range from Fort Worth to Salt Lake City, and Rochester among several other cities. It may be prudent for potential volunteers to select the closest site possible in order to limit their travel requirements."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old

2022. "A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05375838.