Control of Epidemic Influenza Through a School-based Influenza Vaccination Program

Completed · Phase 4

Conditions studied: Influenza

In brief

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 influenza (flu) outbreak in the community. Another purpose is to show that vaccination of these children will significantly reduce breathing problems (in the vaccinated children and unvaccinated people they come in contact with in the community) that require a visit to the doctor for treatment. Another purpose is to continue to collect safety and flu protection information on live attenuated influenza vaccine (LAIV or FluMist) given to children. The study investigators believe that vaccination of healthy school-aged children is an effective plan for preventing many people in the community from catching the flu. Children will take part in the study for 5 to 10 months.

Key facts

Study ID

NCT00138294

Run by

Baylor College of Medicine

People needed

29255

Starts

1998-10-01

Expected to finish

2010-06-01

Last updated by the study team

2017-05-19

Who can join

Age: 4 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Scott & White Hospital and Clinic — Temple, Texas, United States
• Scott & White Hospital and Clinic — Waco, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.