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

Moderna

Status and phase: Enrolling; Phase 2

Conditions: Influenza; SARS-CoV-2

Treatments: Biological: mRNA-1083 Composition 1 Dose A Lot B; Biological: mRNA-1083 Composition 1 Dose A Lot A; Biological: mRNA-1083 Composition 1 Dose B; Biological: COVID-19 Vaccine; Biological: mRNA-1083 Composition 3 Dose A; Biological: Influenza Vaccine; Biological: Investigational COVID-19 Vaccine Lot B; Biological: mRNA-1083 Composition 2 Dose B; Biological: Investigational COVID-19 Vaccine Lot A; Biological: Investigational Influenza Vaccine; Biological: mRNA-1083 Composition 1 Dose C; Biological: mRNA-1083 Composition 2 Dose A; Biological: mRNA-1083 Composition 3 Dose B

Study type: Interventional

Funder types: Industry

Identifiers

NCT06864143

mRNA-1083-P202

Details and patient eligibility

About

The purpose of this study is to evaluate the immunogenicity, reactogenicity, and safety, of mRNA-1083 multicomponent influenza and COVID-19 vaccine in adults ≥18 to <65 years of age.

Enrollment: 1,300 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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 the last COVID-19 vaccine administered >150 days prior to Day 1.

Exclusion criteria

• History of a diagnosis or condition that is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.
• Tested positive for influenza by local health authority-approved testing methods within 150 days prior to Day 1.
• History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 150 days prior to Day 1.
• Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (eg, infliximab), within 180 days prior to Day 1 or plans to do so during the study.
• Received or plans to receive any vaccine authorized or approved by a local health agency within 28 days prior to Day 1 or plans to do so within 28 days post study injection.
• Received a licensed seasonal influenza vaccine within 150 days prior to Day 1.
• Received a licensed/authorized COVID-19 vaccine within 150 days prior to Day 1.
• Received any investigational influenza vaccine, investigational COVID-19 vaccine, or investigational combination vaccine for influenza and COVID-19 within 12 months prior to Day 1.
• Participated in a clinical study with investigational treatment within 90 days prior to Day 1 (Baseline).

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,300 participants in 13 patient groups

mRNA-1083 Composition 1 Dose A Lot A

Experimental group

Description:

Participants will receive single intramuscular (IM) injection of mRNA-1083 Composition 1 at Dose Level A Lot A on Day 1.

Treatment:

Biological: mRNA-1083 Composition 1 Dose A Lot A

mRNA-1083 Composition 1 Dose A Lot B

Experimental group

Description:

Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level A Lot B on Day 1.

Treatment:

Biological: mRNA-1083 Composition 1 Dose A Lot B

mRNA-1083 Composition 1 Dose B

Experimental group

Description:

Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level B on Day 1.

Treatment:

Biological: mRNA-1083 Composition 1 Dose B

mRNA-1083 Composition 1 Dose C

Experimental group

Description:

Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level C on Day 1.

Treatment:

Biological: mRNA-1083 Composition 1 Dose C

mRNA-1083 Composition 2 Dose A

Experimental group

Description:

Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level A on Day 1.

Treatment:

Biological: mRNA-1083 Composition 2 Dose A

mRNA-1083 Composition 2 Dose B

Experimental group

Description:

Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level B on Day 1.

Treatment:

Biological: mRNA-1083 Composition 2 Dose B

mRNA-1083 Composition 3 Dose A

Experimental group

Description:

Participants will receive single IM injection of mRNA-1083 Composition 3 at Dose Level A on Day 1.

Treatment:

Biological: mRNA-1083 Composition 3 Dose A

mRNA-1083 Composition 3 Dose B

Experimental group

Description:

Participants will receive single IM injection of mRNA-1083 Composition 3 at Dose Level B on Day 1.

Treatment:

Biological: mRNA-1083 Composition 3 Dose B

Influenza Vaccine

Active Comparator group

Description:

Participants will receive single IM injection of Influenza Vaccine on Day 1.

Treatment:

Biological: Influenza Vaccine

COVID-19 Vaccine

Active Comparator group

Description:

Participants will receive single IM injection of COVID-19 Vaccine on Day 1.

Treatment:

Biological: COVID-19 Vaccine

Investigational Influenza Vaccine

Active Comparator group

Description:

Participants will receive single IM injection of Investigational Influenza Vaccine on Day 1.

Treatment:

Biological: Investigational Influenza Vaccine

Investigational COVID-19 Vaccine Lot A

Active Comparator group

Description:

Participants will receive single IM injection of Investigational COVID-19 Vaccine Lot A on Day 1.

Treatment:

Biological: Investigational COVID-19 Vaccine Lot A

Investigational COVID-19 Vaccine Lot B

Active Comparator group

Description:

Participants will receive single IM injection of Investigational COVID-19 Vaccine Lot B on Day 1.

Treatment:

Biological: Investigational COVID-19 Vaccine Lot B