Study to Assess the Safety and Immunogenicity of Monovalent mRNA NA Vaccine in Adult Participants 18 Years of Age and Older

Completed · Phase 1

Conditions studied: Influenza Immunization, Healthy Volunteers

In brief

This is a Phase I, first-in-human, randomized, modified double-blind, active-controlled, dose-escalation study to assess the safety and immunogenicity of up to 3 dose levels of mRNA NA vaccines, administered as a single IM injection in healthy adults aged 18 years and older. Two age groups, 18 to 64 years and ≥65 years, will be included in this study.

Key facts

Study ID: NCT05426174
Run by: Sanofi Pasteur, a Sanofi Company
People needed: 233
Starts: 2022-06-09
Expected to finish: 2024-01-03
Last updated by the study team: 2025-09-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Aged 18 years or older on the day of inclusion.
A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile OR
Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration
A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours before administration of study intervention.
Informed consent form has been signed and dated.

You may not qualify if…

Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
Known systemic hypersensitivity to any of the study intervention components; history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
Moderate or severe acute illness/infection (according to investigator judgement) or febrile illness (temperature ≥100.4°F) on the day of study intervention administration.
Have known or recently active (12 months) neoplastic disease or a history of any hematologic malignancy.
Have any diagnosis, current or past, of autoimmune disease.
Body mass index of 40 kg/m2 or higher.
Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
Have taken high-dose inhaled corticosteroid (≥500 μg of fluticasone) within 6 months prior to study vaccination.
Self-reported or documented seropositivity for HIV, hepatitis B virus, or hepatitis C virus.

Where it is running

AES - DRS - Optimal Research_Site 8400007 — Huntsville, Alabama, United States
Central Phoenix Medical Clinic, LLC_Site: 8400010 — Phoenix, Arizona, United States
Optimal Research San Diego, LLC_Site: 8400009 — San Diego, California, United States
AES - DRS - Optimal Research_Site 8400002 — Melbourne, Florida, United States
AES - DRS - Optimal Research_Site 8400001 — Peoria, Illinois, United States
Synexus Clinical Research_Site 8400003 — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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