Influenza Clinical Trial
Official title:
Prospective Pilot Safety Study Administering Two Doses of Inactivated Influenza Vaccine to Infants 10-22 Weeks of Age
This study proposes to enroll 50 young infants, ages 10 to 22 weeks. Each of the fifty infants will receive two 0.25mL doses of preservative-free Fluzone®, given a minimum of 28 days apart but no more than 42 days apart. Preservative-free Fluzone® will not be administered at the same time as other routine vaccines. Approximately 2-3mLs of blood sample will be obtained prior to the first vaccination, approximately 4 weeks after the second vaccination and 6 months after the second vaccination for the measurement of immune response. The primary purpose of this study is twofold: 1.) To determine the safety of administering two doses of preservative-free Fluzone® to young infants and 2.) To determine the capability of inducing an immune response of administering two doses of preservative-free Fluzone® to young infants.
Status | Completed |
Enrollment | 23 |
Est. completion date | October 2006 |
Est. primary completion date | August 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 10 Weeks to 22 Weeks |
Eligibility |
Inclusion Criteria: 1. Healthy infants, 10-22 weeks of age 2. Up to date with routine immunizations (Hepatitis B [Hep B]; diphtheria, tetanus and pertussis [DTaP]; pneumococci [Prevnar]; polio [IPV]; Haemophilus influenzae type B [Hib]) 3. Free of obvious health problems as established by medical history and clinical examination before entering into the study 4. Parent/legal guardian willing and capable of signing written informed consent 5. Parent/legal guardian expected to be available for entire study 6. Parent/legal guardian can be reached by telephone. Exclusion Criteria: 1. History of hypersensitivity to eggs or egg proteins 2. Former premature infants (<37 weeks) 3. History of wheezing or use of bronchodilator medication 4. History of hospitalization (excluding birth) 5. Significant underlying chronic illness (i.e. congenital heart defect, bronchopulmonary dysplasia, HIV) 6. Immunodeficiency disease or use of immunosuppressive therapy by the participant 7. Any other condition which in the clinical judgment of the investigator might interfere with vaccine evaluation 8. Current enrollment and participation in a clinical trial for an investigational drug or vaccine 9. Plans for participation in another clinical trial with an investigational drug or vaccine for the duration of this flu study. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Vanderbilt University | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
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