Status:
COMPLETED
Comparison of Flu Vaccine Doses in Children
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
6-35 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the possibility that giving an increased dose of flu vaccine to children 6 through 35 months of age will improve protection against influenza without increasin...
Detailed Description
Influenza is an important cause of morbidity and mortality among both children and adults. Influenza A and/or B viruses cause yearly epidemics in the United States with an average of 36,000 deaths and...
Eligibility Criteria
Inclusion
- All Subjects
- Healthy children 6-35 months of age (naïve cohort) or 12-35 months of age (fully primed cohort)
- Free of obvious health problems as established by medical history and clinical examination before entering 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
- Fully Primed Cohort
- Have received two doses of 2009-2010 H1N1 and two doses of trivalent inactivated influenza vaccine (TIV) at anytime in the past as defined for the purpose of this study.
Exclusion
- All Subjects:
- Have known allergy to eggs or other components of the vaccine. \*Refer to the Fluzone package insert for a list of vaccine components.
- Known or suspected latex allergy.
- Former premature infants (\<32 weeks).
- History of bronchodilator use more than 2 times per week within 28 days of vaccination.
- Significant underlying chronic illness (e.g., congenital heart disease, bronchopulmonary dysplasia).
- Immunodeficiency disease or use of immunosuppressive therapy by the participant, including perinatal exposure to or infection with human immunodeficiency virus (HIV), or known infection with hepatitis B or hepatitis C.
- Any other condition that, in the clinical judgment of the investigator, may interfere with vaccine evaluation. Children receiving antibiotics are eligible for enrollment.
- Have long term use of glucocorticoids including oral, parenteral or high-dose inhaled steroids (\>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Nasal and topical steroids are allowed.)
- Previous, exposure to an investigational drug or investigational vaccine within 28 days prior to vaccination in this trial.
- Plans for participation in another clinical trial with an investigational drug or investigational vaccine for the duration of this study.
- History of Guillain-Barré syndrome or any other neuromuscular disease.
- History of seizures (including febrile seizures).
- Naïve Cohort:
- Any prior influenza vaccination.
- History of documented laboratory-confirmed influenza infection.
- Fully primed Cohort:
- Have not received two doses of 2009-2010 H1N1 and two doses of trivalent inactivated influenza vaccine (TIV) at anytime in the past as defined for the purpose of this study.
- Allergic response to prior receipt of influenza vaccine.
- Criteria for temporarily delaying vaccine administration for both groups:
- The following conditions are temporary or self-limiting and a subject may be included in the study once the condition(s) has/have resolved, provided that the subject is otherwise eligible:
- Receipt of blood products in the previous 90 days
- Fever (axillary temperature \> 100.0 degrees Fahrenheit/37.8 degrees Celsius), or an acute illness within 48 hours of enrollment.
- Receipt of any live vaccines within four weeks or any inactivated vaccines within two weeks of study vaccination.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT01164553
Start Date
October 1 2010
End Date
October 1 2012
Last Update
April 29 2013
Active Locations (7)
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1
Emory Children's Center - Pediatric Infectious Diseases
Atlanta, Georgia, United States, 30322-1014
2
Emory University School of Medicine - Emory Children's Center - Pediatric Infectious Diseases
Atlanta, Georgia, United States, 30322
3
University of Iowa - Infectious Disease Clinic
Iowa City, Iowa, United States, 52242-1009
4
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
Baltimore, Maryland, United States, 21201-1509