Status:
COMPLETED
A/H5N1 Vaccine in Healthy Children Aged 2-9 Years
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
2-9 years
Phase:
PHASE1
PHASE2
Brief Summary
The purposes of this study are: to make sure that there are no serious side effects of an experimental inactivated influenza A/H5N1 vaccine in children; and to see how the body's immune system reacts ...
Detailed Description
The goals of this study are to assess the safety, reactogenicity, and immunogenicity of 45-microgram dosage level of monovalent subvirion influenza A/H5N1 virus vaccine administered by intramuscular (...
Eligibility Criteria
Inclusion
- The subject must be male or female, aged 2 through 9 years at enrollment.
- The subject must be in good health (and not on any chronic medications), as determined by medical history and a history-directed targeted physical examination.
- Parents or guardians must be able to understand and comply with planned study procedures and be available for all study visits.
- Parents or guardians must provide written consent prior to initiation of any study procedures, and subject may provide written assent as appropriate.
Exclusion
- The subject must not have a known allergy to eggs or other components of the vaccine or sensitivity or allergy to latex.
- The subject must not have a history of asthma or recurrent wheezing.
- The subject must not be undergoing immunosuppression as a result of an underlying illness or treatment.
- The subject must not have an active neoplastic disease or a history of any hematologic malignancy.
- The subject must not be using oral or parenteral steroids, inhaled steroids, or other immunosuppressive or cytotoxic drugs. Note: Subjects on nasal or topical steroids will be allowed to enroll in this study.
- The subject must not have a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
- The subject must not have received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
- The subject must not have an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses (these conditions include, but are not limited to, known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
- The subject must not have a history of severe reactions following immunization with contemporary influenza virus vaccines.
- The subject must not have an acute illness, including an axillary temperature greater than 100 degrees F, within 3 days prior to vaccination.
- The subject must not have received an experimental vaccine or medication within one month prior to enrollment in this study, or expect to receive an experimental vaccine, medication, or blood product during the 13-month study period.
- The subject must not have any condition that would, in the opinion of the investigator, place them at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
- History of Guillain-Barré syndrome.
- The subject must not be participating concurrently in another clinical trial (either in active phase or in follow-up phase).
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT00133536
Start Date
January 1 2006
End Date
April 1 2007
Last Update
August 27 2010
Active Locations (4)
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1
UCLA Center For Vaccine Research
Torrance, California, United States, 90502
2
University of Maryland Baltimore
Baltimore, Maryland, United States, 21201
3
Saint Louis University
St Louis, Missouri, United States, 63104
4
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039