Status:
COMPLETED
Open-Label Study of H5 Vaccine in Participants of Protocol 04-077
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
2-10 years
Phase:
PHASE1
PHASE2
Brief Summary
This study may provide safety information on a flu vaccine given to children and may provide immunogenicity information to add to what was collected in a previous flu vaccine study. Participants will ...
Detailed Description
The recent emergence of novel influenza virus strains in human populations has encouraged efforts to develop vaccines for a potential pandemic. The objectives of this study are to evaluate the safety ...
Eligibility Criteria
Inclusion
- The subject must be male or female, aged 2 through 10 years at enrollment, and must have participated in protocol 04-077 as a placebo recipient or a subject at the UCLA site.
- 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 of the subject must be able to understand and comply with planned study procedures and be available for all study visits.
- Parents or guardians of the subject 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 receive any other inactivated vaccines within 2 weeks before or after any study vaccine or any other live vaccines within 4 weeks before or after any study vaccine 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 or equal to 100 degrees F or an oral temperature greater than or equal to 101 degrees F within 3 days prior to vaccination.
- The subject must not have received an experimental vaccine or medication within 1 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.
- The subject must not have a history of Guillain-Barré syndrome.
- The subject must not be participating concurrently in another clinical trial aside from DMID 04-077 (either in active phase or in follow-up phase).
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00402649
Start Date
February 1 2007
End Date
December 1 2007
Last Update
June 13 2011
Active Locations (3)
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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