mRNA Vaccine for Flu/COVID-19

Recruiting in Palo Alto (17 mi)

+179 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: ModernaTX, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1083 as compared with active control, co-administered licensed influenza and severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) vaccines, in 2 independent age-group sub-study cohorts, healthy adults 65 years and older (Cohort A) and healthy adults 50 to \<65 years of age (Cohort B).

Research Team

Eligibility Criteria

This trial is for healthy adults aged 50 and above who have completed their COVID-19 vaccination series at least 90 days prior. Women of childbearing age must not be pregnant, use contraception, or abstain from pregnancy-causing activities. Exclusions include recent blood donors, those with conditions affecting study participation or interpretation, immunosuppressant users, the acutely ill or febrile, recent vaccine recipients, and those exposed to flu or COVID-19.

Inclusion Criteria

For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, and agreement to continue adequate contraception through 3 months following vaccine administration.

I am fully vaccinated for COVID-19, and my last shot was over 90 days ago.

I am a healthy adult aged 50 or older.

Exclusion Criteria

I haven't had, nor plan to have, any vaccines around the time of the study injections.

I have been on strong immune system medications for more than 14 days in the last 6 months.

I have been in close contact with a COVID-19 case as per CDC guidelines in the last 10 days.

See 5 more

Treatment Details

Interventions

mRNA-1083 (Cancer Vaccine)

Trial OverviewThe trial tests mRNA-1083's effectiveness against both SARS-CoV-2 and influenza compared to licensed vaccines in two age groups: adults over 65 (Cohort A) and those between 50 to under 65 (Cohort B). It measures immune response safety and reaction to the vaccine.

Participant Groups

4Treatment groups

Experimental Treatment

Active Control

Group I: Cohort B1: mRNA-1083 and PlaceboExperimental Treatment2 Interventions

Participants of age 50 to \<65 years will receive mRNA-1083 and placebo administered as 2 IM injections of on Day 1.

Group II: Cohort A1: mRNA-1083 and PlaceboExperimental Treatment2 Interventions

Participants of age 65 years and older will receive mRNA-1083 and placebo administered as 2 intramuscular (IM) injections of on Day 1.

Group III: Cohort A2: Influenza Vaccine and COVID-19 VaccineActive Control2 Interventions

Participants of age 65 years and older will receive age recommended quadrivalent influenza vaccine and COVID-19 vaccine administered as 2 IM injections on Day 1.

Group IV: Cohort B2: Influenza Vaccine and COVID-19 VaccineActive Control2 Interventions

Participants of age 50 to \<65 years will receive age recommended quadrivalent influenza vaccine and COVID-19 vaccine administered as 2 IM injections on Day 1.