Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Age from > = 6 to < 24 months (not having reached 2nd birthday).
Born after a full-term (≥ 37 weeks), and birth weight of >= 2.5 kg (>= 5 pounds, 8 ounces)
History of prior or first attendance as a patient, or as a sibling of a patient, seeking routine immunization or other clinical care at the Hospital Infantíl Robert Reid Cabral (HIRRC)
The parent(s) or legal guardian(s) provide(s) written informed consent and agree(s) to bring the infant back to the clinic for all visits scheduled in the study
Up-to-date for routine doses of vaccines officially recommended for the patient's age in the Dominican Republic to prevent tuberculosis, polio, diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae B
In good health, as determined by medical history and physical examination collected in accordance with the Case Report Form (CRF), and by the clinical judgment of the investigators.

Exclusion Criteria:

Infants WHOSE PARENT(S)/LEGAL GUARDIAN(S):

Are unable or unwilling to give written informed consent for their infant to participate in the study
Cannot be contacted by telephone (family's own or a neighbor's) if necessary for adverse events if scheduled followup return appointments are missed
Are unable to complete the diary for adverse events; are unable to measure and record temperatures or maximal diameter of local reactions or limb circumference; or have difficulty understanding written instructions; or other factors which indicate exclusion in the judgement of the study staff.

INFANTS who:

Have fever (by parental report or by rectal temperature ≥ 38.5° C or axillary ≥ 38.0° C) currently or within the past 3 days, or who are currently suffering from an acute or chronic infectious disease (including known HIV)
Have had an acute or chronic infection requiring systemic antimicrobial therapy (antibiotic or antiviral) or other prescribed treatment within the past 21 days. This includes any underlying illness that may limit their response to vaccination, such as those receiving intravenous immunoglobulin for agammaglobulinemia, or systemic steroid therapy.
Are malnourished, defined by weight less than two standard deviations below the median weight for their age
Are allergic to eggs, or have a history of any anaphylactic shock, asthma, urticaria, or other allergic reaction after previous vaccinations, or have allergy or hypersensitivity to any component of the study vaccine
Have ever previously received any influenza vaccine
Have received within the prior 28 days, or for whom there is the indication to receive in the next 56 days, any non-study vaccination or investigational agent outside of the study
Have a known bleeding diathesis, or any condition with a prolonged bleeding time
Currently have any serious confirmed or suspected disease, such as metabolic, cardiac, or autoimmune disease, or diabetes
Have a history of epilepsy or a seizure disorder, or neurodevelopmental disorders such as autism
Have a genetic anomaly or known cytogenic disorder (e.g., Down's syndrome)
Have leukemia, lymphoma, or any other cancer/neoplasm
Have known or suspected immune dysfunction, including HIV infection, or receives(ed) immunosuppressive therapy, including systemic corticosteroids
Have ever received blood, blood products, or parenteral preparations of immunoglobulin
Have any other serious disease (e.g., with signs of cardiac or renal failure), including progressive neurologic disease
Have any condition which, in the opinion of the investigator, may interfere in the evaluation of the objectives of the study