Phase
Condition
Influenza
Treatment
Adjuvanted Quadrivalent Influenza Vaccine
mRNA-1045
mRNA-1010
Clinical Study ID
Ages 18-80 All Genders Accepts Healthy Volunteers
Study Summary
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
Study Description
Connect with a study center
Washington University in St. Louis
Saint Louis, Missouri 63110
United StatesActive - Recruiting
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