Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Age
0–8
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Aged 6 months to 8 years but not yet 9 years on the day of inclusion.
Subject is healthy, as determined by medical history.
Institution Review Board (IRB)-approved informed assent form signed by eligible subject (if required by local regulations) and/or an IRB-approved informed consent form signed by the subject's parent(s) or legal representative (and by an independent witness if required by local regulations).
Parent or legal guardian willing and able to attend (bring subject) to all scheduled visits and comply with all trial procedures.
You may not be if
Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
Planned participation in another clinical trial during the present trial period.
Personal or family history of Guillain-Barré Syndrome.
Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a vaccine containing the same substances.
Chronic illness at a stage that could interfere with trial conduct or completion
Received blood or blood-derived products in the previous 3 months.
Any vaccination in the 4 weeks preceding or following the trial vaccinations (Subjects can take standard childhood vaccination(s) following Visit 3 blood draw).
Known current human immunodeficiency virus (HIV), hepatitis B (HBsAg) or hepatitis C infection or seropositivity.
Known thrombocytopenia or bleeding disorder contraindicating IM vaccination.
Acute medical illness, with or without fever, within the last 72 hours or an oral temperature ≥ 37.5 °C (99.5 °F) or rectal temperature of ≥ 38°C (100.4 °F) at the time of enrollment.
History of seizures.
Received antibiotics therapy within 72 hours preceding the trial vaccination.
Received any allergy shots in the 7-day period preceding trial vaccination and/or scheduled to receive any allergy shots in the 7-day period after trial vaccination.
Any condition, which in the opinion of the investigator would pose a health risk to the participant.
Clareo Health | Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children
