Safety of a Quadrivalent Influenza Vaccine (VaxigripTetra™) in Subjects Aged 6 Months and Older in Vietnam

Inclusion criteria :

• Aged 6 months and older on the day of inclusion
• Participants aged < 18 years: ICF has been signed and dated by the parent or anotherlegally acceptable representative; Assent form has been signed and dated by theparticipant aged 12 to 15 years.
• Participants aged ≥ 16 years: ICF signed and dated by the participant.
• Participants are able to attend all scheduled visits and to comply with all studyprocedures. For participants aged 6 months to 17 years, parent/legally acceptablerepresentative are able to attend all scheduled visits and to comply with all studyprocedures
• For participants < 2 years: Born at full term of pregnancy (≥ 37 weeks) and/or with abirth weight ≥ 2.5 kg

Exclusion criteria:

• Participant is pregnant, or lactating, or of childbearing potential and not using aneffective method of contraception or abstinence from at least 4 weeks prior tovaccination until at least 4 weeks after vaccination. To be considered ofnon-childbearing potential, a woman must be pre-menarche or post-menopausal for atleast 1 year, or surgically sterile
• Participation at the time of study enrollment (or in the 4 weeks preceding studyvaccination) or planned participation during the present study period in anotherclinical study investigating a vaccine, drug, device, or medical procedure
• Receipt of any vaccine in the 4 weeks preceding the study vaccination or plannedreceipt of any vaccine in the 4 weeks following the study vaccination.
• Receipt of immune globulins, blood or blood-derived products in the past 3 months
• Known or suspected congenital or acquired immunodeficiency; or receipt ofimmunosuppressive 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 vaccine components, or history of alife-threatening reaction to the vaccine used in the study or to a vaccine containingany of the same substances
• Known thrombocytopenia, contraindicating intramuscular vaccination based oninvestigator's judgment
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,contraindicating IM vaccination based on investigator's judgment
• Deprived of freedom by an administrative or court order, or in an emergency setting,or hospitalized involuntarily
• Current alcohol abuse or drug addiction
• Chronic illness that, in the opinion of the investigator, is at a stage where it mightinterfere with study conduct or completion
• Moderate or severe acute illness/infection (according to Investigator judgment) on theday of vaccination or febrile illness/body temperature (temperature ≥ 37.5 C or ≤ 35.5C). A prospective subject should not be included in the study until the condition hasresolved or the febrile event has subsided
• Identified as Investigator or employee of the Investigator or study center with directinvolvement in the proposed study, or identified as an immediate family member (i.e.parent, spouse, natural or adopted child) of the Investigator or employee with directinvolvement in the proposed study The above information is not intended to contain all considerations relevant to a patient'spotential participation in a clinical trial.