A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults
NCT ID: NCT05606965
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
172 participants
INTERVENTIONAL
2022-11-02
2025-11-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Parts A and B - Arm 1: mRNA-1010 (Age Group 18-50 years)
Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
mRNA-1010
Sterile liquid for injection
Parts A and B - Arm 2: Egg-based Quadrivalent Influenza Vaccine (Age Group 18-50 years)
Participants will receive a single dose of egg-based quadrivalent influenza vaccine by IM injection on Day 1.
Egg-based Quadrivalent Influenza Vaccine
Sterile suspension for injection
Parts A and B - Arm 3: Adjuvanted Quadrivalent Influenza Vaccine (Age Group 65-80 years)
Participants will receive a single dose of adjuvanted quadrivalent influenza vaccine by IM injection on Day 1.
Adjuvanted Quadrivalent Influenza Vaccine
Sterile injectable emulsion
Parts A and B - Arm 4: Inactivated Influenza Vaccine (Age Group 65-80 years)
Participants will receive a single dose of inactivated influenza vaccine by IM injection on Day 1.
Inactivated Influenza Vaccine
Sterile suspension for injection
Parts A and B - Arm 5: mRNA-1010 (Age Group 65-80 years)
Participants will receive a single dose of mRNA-1010 by IM injection on Day 1.
mRNA-1010
Sterile liquid for injection
Part C - Arm 1: mRNA-1010 and mRNA-1345 (Age Group 18-50 years)
Participants will receive one dose of mRNA-1010 concomitantly injected with one dose of mRNA-1345 in the contralateral arm at Day 1.
mRNA-1010
Sterile liquid for injection
mRNA-1345
Sterile liquid for injection
Part C - Arm 2: mRNA-1010 and mRNA-1345 (Age Group 18-50 years)
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.
mRNA-1010
Sterile liquid for injection
mRNA-1345
Sterile liquid for injection
Part C - Arm 3: mRNA-1045 (Age Group 18-50 years)
Participants will receive a single dose of mRNA-1045 by IM injection on Day 1.
mRNA-1045
Sterile liquid for injection
Interventions
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mRNA-1010
Sterile liquid for injection
Egg-based Quadrivalent Influenza Vaccine
Sterile suspension for injection
Adjuvanted Quadrivalent Influenza Vaccine
Sterile injectable emulsion
Inactivated Influenza Vaccine
Sterile suspension for injection
mRNA-1345
Sterile liquid for injection
mRNA-1045
Sterile liquid for injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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Washington University in St. Louis
St Louis, Missouri, United States
Countries
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Other Identifiers
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mRNA-CRID-003
Identifier Type: -
Identifier Source: org_study_id
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