Status:
COMPLETED
Inactivated Influenza Vaccine in Infants 10-22 Weeks of Age
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
10-22 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
Influenza virus is an important global cause of morbidity and mortality. Influenza A or B viruses cause epidemics of disease almost every winter in the United States with an average of 36,000 deaths a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00231920
Start Date
October 1 2004
End Date
October 1 2006
Last Update
August 12 2011
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
2
Vanderbilt University
Nashville, Tennessee, United States, 37232-2573