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

Last updated: March 9, 2025
Sponsor: ModernaTX, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Influenza

Treatment

Adjuvanted Quadrivalent Influenza Vaccine

mRNA-1045

mRNA-1010

Clinical Study ID

NCT05606965
mRNA-CRID-003
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults 18-50 years (Study Parts A, B, and C) and 65-80 years (Study Parts A and Bonly) 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^2at the Screening Visit. There will be no BMI requirement for inclusion in Part B andPart C.

  • A person of childbearing potential (POCBP): has a negative highly sensitivepregnancy test at the Screening Visit and before each administration of studyintervention; 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 studyintervention; and is not currently pregnant or breastfeeding.

Exclusion

Exclusion Criteria:

  • Acutely ill or febrile (temperature ≥ 38.0°Celsius (C)/100.4° Fahrenheit (F) hoursbefore or at the D1 vaccination visit. Participants meeting this criterion may berescheduled within the 28-day screening window.

  • Any medical, psychiatric, or occupational condition, including reported history ofsubstance abuse, that, in the opinion of the Investigator, might pose additionalrisk due to participation in the study or could interfere with the interpretation ofstudy results.

  • Reported history of congenital or acquired immunodeficiency, immunocompromizing orimmunosuppressive 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 immunosuppressivetherapy 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 ofprednisone or equivalent) for > 14 days in total within 180 days before vaccinationvisit (D1) or is anticipating the need for systemic immunosuppressive treatment atany time during participation in the study (including intra-articular steroidinjections). Inhaled, nasal, and topical steroids are allowed.

  • Has received systemic immunoglobulins or long-acting biological therapies that maysuppress or alter immune responses (for example, Infliximab®) or blood productswithin 90 days before the vaccination visit or plans to receive them during thestudy.

  • Has a history of anaphylaxis or severe hypersensitivity reaction after receipt ofany mRNA or influenza vaccines or any components of the mRNA or influenza vaccines,including egg protein.

Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Total Participants: 325
Treatment Group(s): 6
Primary Treatment: Adjuvanted Quadrivalent Influenza Vaccine
Phase: 2
Study Start date:
November 02, 2022
Estimated Completion Date:
November 11, 2025

Study 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.

Connect with a study center

  • Washington University in St. Louis

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

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