The purpose of the study is to find out if children 5 through 8 years of age who are getting influenza vaccine for the first time should get one or two doses.

Condition	Intervention	Phase
Influenza	Vaccine: Fluzone	Phase IV

Further Study Details: 

Primary Outcomes: Immunogenicity of one dose vs two doses of influenza vaccine.
Secondary Outcomes: Overall reactogenicity of influenza vaccine in one dose vs two doses.
Expected Total Enrollment:  250

Currently, two doses of influenza vaccine are recommended for children younger than 9 years receiving influenza vaccine for the first time. While the scientific support for 2 doses of vaccine in infants and toddlers is sound, the need for 2 doses of vaccine for adequate immunogenicity in older children is less certain. If the immunogenicity of a one-dose vaccine regimen is comparable to a two-dose regimen, then one dose would be preferable for reasons of safety, practicality and economics, and would reduce a major barrier to vaccination in this injection-adverse age group. This study will compare the immunogenicity and reactogenicity of one versus two doses of influenza vaccine in children aged 5 to 8 years old receiving influenza vaccine for the first time. All children enrolled in the study will receive two doses of vaccine, and the immune response after one dose of vaccine will be compared to the immune response after two doses of vaccine.

Ages Eligible for Study:  5 Years   -   8 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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.

Washington
      Group Health Cooperative Center for Health Studies, Seattle,  Washington,  98101,  United States

Study chairs or principal investigators

Lisa A Jackson, MD, MPH,  Principal Investigator,  Group Health Cooperative   

Study ID Numbers:  CDC Protocol 4258; VSD contract #200-2002-00732
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00158665
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13