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mRNA-1083 Composition 1 Dose A Lot A

Phase 2

Influenza | Vaccine | Infectious Disease |Moderna, Inc.|Trials Updated: Oct 20, 2025

mRNA-1083 Composition 1 Dose A Lot A development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Mar 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment1,320

FDA Designations

No designations recorded

mRNA-1083 Composition 1 Dose A Lot A clinical trials

mRNA-1083 Composition 1 Dose A Lot A · 1 trial · 2 indications

Phase 2 1
NCT06864143A Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of AgeInfluenza
COMPLETED1,320 Analytics
PHASE2COMPLETED
A Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza
Day 29
Geometric Mean Concentration (GMC) as Measured by Pseudovirus Neutralization Assay (PsVNA) for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Day 29
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Day 1 through 7 days after study injection
Number of Participants With Unsolicited Adverse Events (AEs)
Day 1 through 28 days after study injection
Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation From the Study
Day 1 through Day 181

Secondary Endpoints

Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza as Measured by HAI Assay
Baseline (Day 1), Day 29
GMFR of Antibodies for SARS-CoV-2 as Measured by PsVNA
Baseline (Day 1), Day 29
Influenza: Percentage of Participants with Seroconversion as Measured by HAI Assay
Baseline (Day 1) to Day 29
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
mRNA-1083 Composition 1 Dose A Lot AEXPERIMENTALParticipants will receive single intramuscular (IM) injection of mRNA-1083 Composition 1 at Dose Level A Lot A on Day 1.
mRNA-1083 Composition 1 Dose A Lot BEXPERIMENTALParticipants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level A Lot B on Day 1.
mRNA-1083 Composition 1 Dose BEXPERIMENTALParticipants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level B on Day 1.
mRNA-1083 Composition 1 Dose CEXPERIMENTALParticipants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level C on Day 1.
mRNA-1083 Composition 2 Dose AEXPERIMENTALParticipants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level A on Day 1.
mRNA-1083 Composition 2 Dose BEXPERIMENTALParticipants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level B on Day 1.
mRNA-1083 Composition 3 Dose AEXPERIMENTALParticipants will receive single IM injection of mRNA-1083 Composition 3 at Dose Level A on Day 1.
mRNA-1083 Composition 3 Dose BEXPERIMENTALParticipants will receive single IM injection of mRNA-1083 Composition 3 at Dose Level B on Day 1.
Influenza VaccineACTIVE_COMPARATORParticipants will receive single IM injection of Influenza Vaccine on Day 1.
COVID-19 VaccineACTIVE_COMPARATORParticipants will receive single IM injection of COVID-19 Vaccine on Day 1.
Investigational Influenza VaccineACTIVE_COMPARATORParticipants will receive single IM injection of Investigational Influenza Vaccine on Day 1.
Investigational COVID-19 Vaccine Lot AACTIVE_COMPARATORParticipants will receive single IM injection of Investigational COVID-19 Vaccine Lot A on Day 1.
Investigational COVID-19 Vaccine Lot BACTIVE_COMPARATORParticipants will receive single IM injection of Investigational COVID-19 Vaccine Lot B on Day 1.

Interventions

NameTypeDescription
mRNA-1083 Composition 1 Dose A Lot ABIOLOGICALSterile liquid for injection
mRNA-1083 Composition 1 Dose A Lot BBIOLOGICALSterile liquid for injection
mRNA-1083 Composition 1 Dose BBIOLOGICALSterile liquid for injection
mRNA-1083 Composition 1 Dose CBIOLOGICALSterile liquid for injection
mRNA-1083 Composition 2 Dose ABIOLOGICALSterile liquid for injection
mRNA-1083 Composition 2 Dose BBIOLOGICALSterile liquid for injection
mRNA-1083 Composition 3 Dose ABIOLOGICALSterile liquid for injection
mRNA-1083 Composition 3 Dose BBIOLOGICALSterile liquid for injection
Influenza VaccineBIOLOGICALSterile liquid for injection
COVID-19 VaccineBIOLOGICALSterile liquid for injection
Investigational Influenza VaccineBIOLOGICALSterile liquid for injection
Investigational COVID-19 Vaccine Lot ABIOLOGICALSterile liquid for injection
Investigational COVID-19 Vaccine Lot BBIOLOGICALSterile liquid for injection
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersYes
Study Sites17

Inclusion Criteria: * Medically stable. * Participants who could become pregnant: negative pregnancy test and contraception for at least 28 days prior to Day 1 and for at least 90 days after the study intervention administration. * Have received ≥2 coronavirus disease 2019 (COVID-19) vaccines, with...

Countries:United States
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Frequently asked questions about mRNA-1083 Composition 1 Dose A Lot A

What is mRNA-1083 Composition 1 Dose A Lot A?

mRNA-1083 Composition 1 Dose A Lot A is an investigational mRNA vaccine developed by Moderna, Inc. for influenza. It is a Phase 2 candidate in the infectious disease therapeutic area. The specific lot designation refers to a particular formulation and dose used in clinical testing.

What is mRNA-1083 Composition 1 Dose A Lot A used for?

It is being studied for influenza, and the Phase 2 trial also enrolled participants with SARS-CoV-2 as a condition, indicating the vaccine was evaluated against both influenza and COVID-19. It is an investigational product and has not been approved for use.

Who makes mRNA-1083 Composition 1 Dose A Lot A?

Moderna, Inc. (ticker MRNA) is the developer of mRNA-1083 Composition 1 Dose A Lot A. Moderna is the sponsor of the clinical program evaluating this vaccine candidate for influenza and SARS-CoV-2.

What phase is mRNA-1083 Composition 1 Dose A Lot A in?

mRNA-1083 Composition 1 Dose A Lot A is in Phase 2 development. The single registered trial, NCT06864143, is listed as completed. The vaccine remains investigational and is not approved for any indication.

What clinical trials is mRNA-1083 Composition 1 Dose A Lot A in?

One trial has evaluated mRNA-1083 Composition 1 Dose A Lot A: NCT06864143, a Phase 2 study of the mRNA-1083 influenza and COVID-19 vaccine in adults 18 to under 65 years of age. It was randomized, double-blind, active-controlled, enrolled 1,320 participants in the United States, and is completed.

How was the mRNA-1083 Composition 1 Dose A Lot A trial designed?

NCT06864143 was a randomized, double-blind, active-controlled Phase 2 trial of mRNA-1083 Composition 1 Dose A Lot A in healthy adults aged 18 to under 65 years. It enrolled 1,320 participants across United States sites and assessed immunogenicity, reactogenicity, and safety. The study is completed.