Inactivated Influenza Vaccine in Infants 10-22 Weeks of Age
Completed · Phase 1
Conditions studied: Influenza
In brief
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.
Key facts
- Study ID
- NCT00231920
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 23
- Starts
- 2004-10-01
- Expected to finish
- 2006-10-01
- Last updated by the study team
- 2011-08-12
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy infants, 10-22 weeks of age
- Up to date with routine immunizations (Hepatitis B [Hep B]; diphtheria, tetanus and pertussis [DTaP]; pneumococci [Prevnar]; polio [IPV]; Haemophilus influenzae type B [Hib])
- Free of obvious health problems as established by medical history and clinical examination before entering into the study
- Parent/legal guardian willing and capable of signing written informed consent
- Parent/legal guardian expected to be available for entire study
- Parent/legal guardian can be reached by telephone.
You may not qualify if…
- History of hypersensitivity to eggs or egg proteins
- Former premature infants (<37 weeks)
- History of wheezing or use of bronchodilator medication
- History of hospitalization (excluding birth)
- Significant underlying chronic illness (i.e. congenital heart defect, bronchopulmonary dysplasia, HIV)
- Immunodeficiency disease or use of immunosuppressive therapy by the participant
- Any other condition which in the clinical judgment of the investigator might interfere with vaccine evaluation
- Current enrollment and participation in a clinical trial for an investigational drug or vaccine
- Plans for participation in another clinical trial with an investigational drug or vaccine for the duration of this flu study.
Where it is running
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- Vanderbilt University — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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