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mRNA-1083 Composition 1 Dose A Lot A

Phase 2

Influenza | Monoclonal antibody | Infectious Disease |Moderna, Inc.|Last Updated: Oct 20, 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

Clinical trial landscape

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
Influenza
NCT068641431,320
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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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Competitive Landscape -Influenza 14 trials

CompanyTickerTrialsLead PhaseDrugs
Sinovac Biotech Ltd.SVA1PHASE3Participants will receive one dose of vaccine of Sinovac QIV, Vaxigrip QIV
GSK plc Sponsored ADRGSK2PHASE2Flu mRNA, Comparator 1, Comparator 2, Comparator 3
Moderna, Inc.MRNA1PHASE3mRNA-1018-H5
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Traws Pharma, Inc.TRAW2PHASE2TRX-100
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
Sanofi SA Sponsored ADRSNY2 - Efluelda Tetra Pre-filled syringe
Pfizer Inc.PFE1 - COVID-19 Vaccine
Abbott LaboratoriesABT1N/AUndisclosed
Grace Therapeutics, Inc.GRCE1N/AUndisclosed
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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 used for?

mRNA-1083 Composition 1 Dose A Lot A is an investigational vaccine being studied for the prevention of influenza. It is being developed by Moderna, Inc. and is currently in Phase 2 clinical development. The vaccine is also being investigated for its potential to protect against SARS-CoV-2, the virus that causes COVID-19.

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

mRNA-1083 Composition 1 Dose A Lot A is being developed by Moderna, Inc., a biotechnology company publicly traded under the ticker symbol MRNA. The company is conducting clinical trials to evaluate the vaccine's immunogenicity, reactogenicity, and safety in adult populations.

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

mRNA-1083 Composition 1 Dose A Lot A is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the vaccine is being studied for its ability to generate an immune response against influenza and SARS-CoV-2.

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

mRNA-1083 Composition 1 Dose A Lot A is associated with clinical trial NCT06864143, a Phase 2 study that has been completed. The trial enrolled 1,320 participants aged 18 to under 65 years in the United States. It was a randomized, double-blind, active-controlled study investigating the vaccine's immunogenicity, reactogenicity, and safety.

Is mRNA-1083 Composition 1 Dose A Lot A the same as mRNA-1083?

mRNA-1083 Composition 1 Dose A Lot A is a specific formulation of the mRNA-1083 vaccine, which is designed to target both influenza and COVID-19. The vaccine is being developed by Moderna, Inc. and is currently in Phase 2 clinical trials. The specific composition and dose are being evaluated for safety and immunogenicity.