Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi Pasteur, a Sanofi Company
Study duration is approximately 12 months.
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Aged 18 years on the day of inclusion (US) and aged 21 years on the day of inclusion (Puerto Rico)
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.
You may not be if
Participants are excluded from the study if any of the following criteria apply:
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)
Previous history of myocarditis, pericarditis, and / or myopericarditis
Self-reported thrombocytopenia, contraindicating Intramuscular vaccination based on Investigator's judgment
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating Intramuscular vaccination based on Investigator's judgment
Moderate or severe acute illness / infection (according to Investigator's judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
Self-reported or documented seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Clareo Health | Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adult Participants18 Years of Age and Older
