Status:
COMPLETED
Control of Epidemic Influenza Through a School-based Influenza Vaccination Program
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Scott and White Hospital & Clinic
Novartis
Conditions:
Influenza
Eligibility:
All Genders
4-18 years
Phase:
PHASE4
Brief Summary
The main purpose of this study is to learn if influenza vaccines (live attenuated and inactivated influenza vaccines), when given to school-aged children 4 to 18 years of age, can stop or lessen the i...
Detailed Description
This study was conducted in three phases. The first phase spanned from 1998-2003 (PubMed ID:14706961; PubMed ID: 12915495) and the second phase spanned from 2003-2007 (PubMedID: 18401289; PubMed ID: 1...
Eligibility Criteria
Inclusion
- signed informed consent form by adult participant or parent/ legal guardian who are able to understand and comply with the protocol and assent when appropriate (usually age greater than or equal to 7 years)
- healthy subject, 4 through 18 years of age and none of the exclusion criteria
Exclusion
- history of hypersensitivity, especially anaphylactic reaction, to any components of FluMist™, including eggs or egg products
- on aspirin therapy or aspirin-containing therapy
- history of Guillain-Barré syndrome
- known or suspected immune deficiency diseases such as combined immunodeficiency, agammaglobulinemia, and thymic abnormalities and conditions such as human immunodeficiency virus infection, malignancy, leukemia or lymphoma
- on immunosuppressive therapies such as systemic corticosteroids, alkylating drugs, antimetabolites, or radiation
- close contact within 21 days after vaccination with immunocompromised individuals
- history of asthma or reactive airway disease
- history of chronic or underlying diseases for which the licensed inactivated flu vaccine (IIV-T) is recommended such as chronic disorders of the cardiovascular and pulmonary systems, or chronic conditions such as metabolic diseases, renal dysfunction or hemoglobinopathies that required medical follow-up or hospitalization during the preceding year
- concurrent use with an anti-influenza compound
- pregnant or plans to become pregnant within 42 days after vaccination
- nursing mother and
- any condition which, in the opinion of the investigator, interferes with evaluation of the vaccine
Key Trial Info
Start Date :
October 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
29255 Patients enrolled
Trial Details
Trial ID
NCT00138294
Start Date
October 1 1998
End Date
June 1 2010
Last Update
May 19 2017
Active Locations (2)
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1
Scott & White Hospital and Clinic
Temple, Texas, United States, 76508
2
Scott & White Hospital and Clinic
Waco, Texas, United States, 76710