A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults

Moderna

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Biological: mRNA-1045; Biological: Inactivated Influenza Vaccine; Biological: mRNA-1345; Biological: Adjuvanted Quadrivalent Influenza Vaccine; Biological: Egg-based Quadrivalent Influenza Vaccine; Biological: mRNA-1010

Study type: Interventional

Funder types: Industry

Identifiers

NCT05606965

mRNA-CRID-003

Details and patient eligibility

About

The main purpose of the study is to evaluate the safety, reactogenicity, and the humoral immunogenicity of mRNA-1010 and comparator influenza vaccines against homologous influenza A and B strains at Day 29.

Full description

The study consists of 3 parts. Part A of the study was conducted for the 2022-23 influenza season. Part B of the study was conducted in 2023-24 influenza season. Part C of the study will be conducted in 2024-25 influenza season.

Enrollment: 172 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults 18-50 years (Study Parts A, B, and C) and 65-80 years (Study Parts A and B only) of age at the time of consent (Screening Visit).
• Part A only: Body mass index (BMI) of 18 kilograms (kg)/meter (m)^2 to < 40 kg/m^2 at the Screening Visit. There will be no BMI requirement for inclusion in Part B and Part C.
• A person of childbearing potential (POCBP): has a negative highly sensitive pregnancy test at the Screening Visit and before each administration of study intervention; must use a contraceptive method that is highly effective from at least 28 days prior to Day 1 (Baseline) to at least 3 months after the last study intervention; and is not currently pregnant or breastfeeding.

Exclusion criteria

• Acutely ill or febrile (temperature ≥ 38.0°Celsius (C)/100.4° Fahrenheit (F) hours before or at the D1 vaccination visit. Participants meeting this criterion may be rescheduled within the 28-day screening window.
• Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
• Reported history of congenital or acquired immunodeficiency, immunocompromizing or immunosuppressive condition, asplenia, or history of recurrent severe infections. Certain immune-mediated conditions that are stable and well-controlled (for example, Hashimoto's thyroid disease) or that do not require systemic immunosuppressive therapy may be permitted at the discretion of the Investigator.
• Dermatologic conditions that could affect local solicited AR assessments (tattoos, psoriatic patches or vitiligo affecting skin over the deltoid injection site area).
• Has received systemic immunosuppressants (for glucocorticoids ≥ 10 mg/day of prednisone or equivalent) for > 14 days in total within 180 days before vaccination visit (D1) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed.
• Has received systemic immunoglobulins or long-acting biological therapies that may suppress or alter immune responses (for example, Infliximab®) or blood products within 90 days before the vaccination visit or plans to receive them during the study.
• Has a history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA or influenza vaccines or any components of the mRNA or influenza vaccines, including egg protein.

Other protocol-defined inclusion/exclusion criteria apply.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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172 participants in 8 patient groups

Parts A and B - Arm 1: mRNA-1010 (Age Group 18-50 years)

Experimental group

Description:

Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.

Treatment:

Biological: mRNA-1010

Parts A and B - Arm 2: Egg-based Quadrivalent Influenza Vaccine (Age Group 18-50 years)

Active Comparator group

Description:

Participants will receive a single dose of egg-based quadrivalent influenza vaccine by IM injection on Day 1.

Treatment:

Biological: Egg-based Quadrivalent Influenza Vaccine

Parts A and B - Arm 3: Adjuvanted Quadrivalent Influenza Vaccine (Age Group 65-80 years)

Active Comparator group

Description:

Participants will receive a single dose of adjuvanted quadrivalent influenza vaccine by IM injection on Day 1.

Treatment:

Biological: Adjuvanted Quadrivalent Influenza Vaccine

Parts A and B - Arm 4: Inactivated Influenza Vaccine (Age Group 65-80 years)

Active Comparator group

Description:

Participants will receive a single dose of inactivated influenza vaccine by IM injection on Day 1.

Treatment:

Biological: Inactivated Influenza Vaccine

Parts A and B - Arm 5: mRNA-1010 (Age Group 65-80 years)

Experimental group

Description:

Participants will receive a single dose of mRNA-1010 by IM injection on Day 1.

Treatment:

Biological: mRNA-1010

Part C - Arm 1: mRNA-1010 and mRNA-1345 (Age Group 18-50 years)

Experimental group

Description:

Participants will receive one dose of mRNA-1010 concomitantly injected with one dose of mRNA-1345 in the contralateral arm at Day 1.

Treatment:

Biological: mRNA-1010

Biological: mRNA-1345

Part C - Arm 2: mRNA-1010 and mRNA-1345 (Age Group 18-50 years)

Experimental group

Description:

Participants will receive one dose of mRNA-1010 at Day 1 followed by one dose of mRNA-1345 in the contralateral arm at Day 29.

Treatment:

Biological: mRNA-1010

Biological: mRNA-1345

Part C - Arm 3: mRNA-1045 (Age Group 18-50 years)

Experimental group

Description:

Participants will receive a single dose of mRNA-1045 by IM injection on Day 1.

Treatment:

Biological: mRNA-1045