Status:
COMPLETED
A Phase I Safety and Immunogenicity Study of Mix and Match of Licensed Flu Vaccine and Flumist
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
12-35 years
Phase:
PHASE1
Brief Summary
The purpose of this research is to compare the safety and ability to stimulate antibodies (part of the bodies proteins that fight infections) of two influenza (flu) vaccines given to children 12 to 35...
Detailed Description
This multi-site study is a phase I, open-label, 4-arm trial to evaluate 2 doses of influenza vaccine separated by 30 days. The vaccine will either be two doses of a single vaccine or a combination of ...
Eligibility Criteria
Inclusion
- Twelve to 35 months of age at enrollment.
- Minimum weight of 8 kg.
- In good health, as determined by parent/guardian verbal medical history and physical examination by clinical investigator.
- Parent/guardian available by telephone for safety data collection through 6 months post-dose 2.
- Ability of parent/guardian to understand and comply with the requirements of the protocol.
- Signed informed consent document and Health Insurance Portability and Accountability Act (HIPAA) authorization by the parent/guardian prior to performance of any study procedures.
Exclusion
- History of hypersensitivity to any component of LAIV or TIV, including egg or egg products.
- History of hypersensitivity to gentamicin.
- Known or suspected immune deficiency diseases or immunosuppressed or have altered or compromised immune status as a consequence of treatment with immunosuppressive therapies.
- Known close contact with a severely immunocompromised person, such as someone currently in isolation secondary to a bone marrow transplantation (LAIV recipients should avoid close contact with severely immunocompromised individuals for at least 7 days after vaccination).
- History of chronic underlying medical conditions such as chronic disorders of the cardiovascular and pulmonary systems, chronic metabolic diseases (including diabetes), renal dysfunction, or hemoglobinopathies.
- History of Guillain-Barré syndrome.
- History of asthma or reactive airways disease.
- Acute febrile (\>99.6 degrees Fahrenheit axillary) and/or respiratory illness, within the 72 hours prior to enrollment.
- Use of aspirin or aspirin containing products in the month prior to enrollment or anticipated use during the study.
- Administration of any intranasal medication within 2 weeks prior to enrollment or expected receipt during this study.
- Previous receipt of an influenza vaccine.
- Administration of any live virus vaccine within 4 weeks prior to enrollment or (other than study vaccine) planned receipt of another live virus vaccine before completion of the 2 weeks after the last vaccination in this study\*
- Administration of any inactivated vaccine within 2 weeks prior to enrollment or planned receipt of another inactivated vaccine before 2 weeks after the last vaccination in this study\*
- Participation in another investigational trial or administration of any investigational drug within 1 month prior to enrollment or during this study.
- Any condition that in the opinion of the investigator would interfere with the interpretation or evaluation of the vaccine.
- Routine immunizations can be resumed after the memory aid period following dose 2.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00231907
Start Date
September 1 2005
End Date
March 1 2007
Last Update
August 27 2010
Active Locations (3)
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1
Saint Louis University
St Louis, Missouri, United States, 63104
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
3
Vanderbilt University
Nashville, Tennessee, United States, 37232