Immunogenicity and Safety Trial of Adjuvanted and Non-adjuvanted Trivalent Influenza Vaccine in Tropical Africa

This is an interventional prevention trial for Influenza focused on measuring influenza, influenza vaccine, immunogenicity, Africa, Senegal Read More

Inclusion Criteria:

• A male or female child at least 6 months of age and under 6 years of age (has not yet reached 72 months of age) at the enrollment visit.
• Free of obvious health problems, as established by the medical history and screening evaluations, including physical examination.
• Subject's parent or legal guardian is willing to provide written informed consent prior to the subject's first study vaccination.

Exclusion Criteria:

• Known hypersensitivity to any component in adjTIV or TIV (which include egg protein) or placebo.
• Receipt of any non-study vaccine within two weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 56 visit.
• Previous receipt of any influenza vaccine.
• Hypersensitivity after previous administration of any vaccine.
• Acute illness accompanied by a body temperature of 37.5°C or greater (axillary measurement) within 14 days of enrollment visit. (Enrollment and administration of adjTIV, TIV, or placebo should be postponed until at least 14 days after recovery. Minor illnesses, such as mild upper respiratory infection, with an axillary temperature of <37.5°C, are not reason for exclusion or postponing study vaccination.)
• Any condition that, in the opinion of the investigator, would pose a health risk to the participant if he/she participates in the study or would interfere with the evaluation of the study objectives.