A Comparison of One Vs Two Doses of Influenza Vaccine in Children 5-8 Years of Age - Article Avian flu; Bird flu; Bird flu (avian influenza); H5N1
Clinical Trial: A Comparison of One Vs Two Doses of Influenza Vaccine in Children 5-8 Years of Age
This study is no longer recruiting patients.
|Influenza || Vaccine: Fluzone ||Phase IV |
MedlinePlus related topics: Flu
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Secondary Outcomes: Overall reactogenicity of influenza vaccine in one dose vs two doses.
Expected Total Enrollment: 250
Study start: August 2004; Study completion: April 2006
Last follow-up: December 2004; Data entry closure: April 2005
Accepts Healthy Volunteers
- 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.
- 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.
Group Health Cooperative Center for Health Studies, Seattle, Washington, 98101, United States
Lisa A Jackson, MD, MPH, Principal Investigator, Group Health Cooperative
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