A Comparison of One Versus Two Doses of Influenza Vaccine in Children 5-8 Years of Age

Inclusion Criteria:

• Immunocompetent children who are at least 5 and no more than 8 years of age on the date of the first vaccination.
• Parents able to give informed consent and child available for all study visits.
• Family able to understand and comply with planned study procedures.
• Family must have telephone accessibility.

Exclusion Criteria:

• Previous receipt of influenza vaccine of any kind (shot or nasal spray).
• Active cancer or blood system abnormalities such as leukemia.
• Immunocompromising illnesses or current receipt of immunosuppressive agents
• Allergy to eggs or egg protein, or to gentamicin (an antibiotic that is present in trace amounts in the vaccine).
• Any acute or chronic condition that (in the opinion of the investigator) would render vaccination unsafe or would interfere with the evaluation of responses.

Temporary Exclusion Criteria:

Acute disease, defined as the presence of moderate or severe illness with or without fever, at the time of enrollment. Influenza vaccine may be administered to children with minor illnesses, such as diarrhea, mild upper respiratory infection and low-grade febrile illness with an oral temperature <100.4 F.