Comparison of Inactivated and Live, Attenuated Influenza Vaccine in Children 5-9 Years of Age-Year 3 Amendment - Article Avian flu; Bird flu; Bird flu (avian influenza); H5N1
Clinical Trial: Comparison of Inactivated and Live, Attenuated Influenza Vaccine in Children 5-9 Years of Age-Year 3 Amendment
This study is currently recruiting patients.
Verified by National Institute of Allergy and Infectious Diseases (NIAID) August 2005
|Influenza || Vaccine: FluMist |
|Phase IV |
MedlinePlus related topics: Flu
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Parallel Assignment
Official Title: A Randomized Comparison of the Immune Response to Either Inactivated or Live, Attenuated Influenza Vaccine in Children 5-9 Years of Age. Subset Follow-Up for NP Samples for Influenza PCR.
Expected Total Enrollment: 40
Accepts Healthy Volunteers
- Healthy children aged 5-9 years of age.
- Parents willing to sign informed consent.
- Availability for follow-up for the planned duration of the study at least 4 weeks after last immunization.
- Acceptable medical history by screening evaluation and brief clinical assessment.
- History of immunodeficiency.
- Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.
- Household contact with immunodeficiency due to disease, medication or radiation.
- Child receiving aspirin therapy or aspirin-containing therapy.
- History of Guillain-Barr� syndrome.
- Malignancy, other than squamous cell or basal cell skin cancer.
- Autoimmune disease.
- History of asthma or reactive airways disease.
- Chronic cardiovascular and pulmonary disorder.
- Chronic metabolic diseases (including diabetes), renal dysfunction or hemoglobinopathies requiring regular medical follow-up or hospitalization during the preceding year.
- Use of immunosuppressive medication. Corticosteroid nasal sprays are permissible.
- Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol.
- Inactivated vaccine 14 days prior to vaccination.
- Live, attenuated vaccines within 60 days of study.
- Use of investigational agents within 30 days prior to study.
- Receipt of blood products or immunoglobulin in the past 6 months.
- Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment.
- Acute febrile illness on the day of vaccination.
- Known allergies to any component of the vaccine, including thimerosal.
- History of allergy to eggs or egg products.
- Any condition that, in the opinion of the investigator, might interfere with study objectives.
Location and Contact Information
Stanford University School of Medicine, Stanford, California, 94305, United States; Recruiting
Last Updated: August 29, 2005
Record first received: August 26, 2005
ClinicalTrials.gov Identifier: NCT00138385
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-30