Phase 4
N=29,255
Control of Epidemic Influenza Through a School-based Influenza Vaccination Program
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00138294 ↗Enrolled (actual)
29,255
Serious AEs
0.2%
Results posted
May 2017
Primary outcome: Primary: MAARI Rate During the Epidemic Period (2007-2008) — 12503; 18998 Number of MAARI
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- live attenuated and inactivated influenza vaccines (Biological)
- Age
- Pediatric, Adult · 4+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MAARI Rate During the Epidemic Period (2007-2008) |
12503; 18998 | — |
| PRIMARY MAARI Rate During the Epidemic Period (2008-2009) |
6630; 12429 | — |
| PRIMARY MAARI Rate During the Epidemic and Pandemic Period (2009-2010) |
15155; 25984 | — |
| SECONDARY Proportion of SAEs Detected in LAIV Recipients |
0.00005; 0.00012 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00138294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.