Study to Assess Safety and Immunogenicity of an Egg-based H5N8 Influenza Vaccine at Multiple Dose Levels Adjuvanted With Matrix-M in Healthy Participants 18 Years of Age and Above.
Participants who are healthy as determined by medical evaluation including medical history
Not pregnant/breastfeeding; non-childbearing potential or uses effective contraception/abstinence from ≥4 weeks before the first study intervention dose to ≥8 weeks after the last dose
Informed consent form has been signed and dated
Able to attend all scheduled visits and to comply with all study procedures
Covered by health insurance, if required by local regulations
You may not be if
Known or suspected immunodeficiency; immunosuppressive therapy in past 6 months; or long-term systemic corticosteroid (eg, prednisone for more than 2 weeks in the past 3 months)
Known hepatitis B or hepatitis C infection (based on medical history)
Known personal or family history of previous episodes of Guillan-Barré syndrome (GBS), neuritis (including Bell's palsy), convulsions, encephalitis, transverse myelitis, and vasculitis
Known systemic hypersensitivity to any of the study intervention components or history of life-threatening reaction to the study interventions or products with same substances
Self-reported thrombocytopenia contraindicating intramuscular (IM) injection based on investigator's judgment
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection based on investigator's judgment
Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
History of A/H5 infection prior to the study participation
Moderate or severe acute illness/infection (per investigator judgment)/fever (≥ 38.0°C \[≥ 100.4°F\]) on study intervention day. Include participant only after the condition or fever has resolved
Alcohol, prescription drug, or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion
Any vaccine given 4 weeks before first study intervention or any planned vaccination to be given prior to Day 43 (ie, approximately 21 days after the second study intervention)
Previous vaccination against A(H5) with an investigational or marketed vaccine. This includes, but is not limited to, influenza subtypes A(H5N1), A(H5N8), and A(H5N6)
Has received a blood transfusion or blood-derived products, including immunoglobulins in the past 3 months
Participation in another clinical study for a vaccine, drug, medical device, or medical procedure within 4 weeks before enrollment or planned participation during the present study period
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
Is an investigator, investigator/study center employee, or immediate family member (parent, spouse, natural/adopted child) of the investigator/employee with direct involvement in the study
Any screening safety laboratory parameters out of normal ranges and assessed as \> Grade 2
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Clareo Health | Study to Assess Safety and Immunogenicity of an Egg-based H5N8 Influenza Vaccine at Multiple Dose Levels Adjuvanted With Matrix-M in Healthy Participants 18 Years of Age and Above.
