At a glance
ClinicalIndex Comparison Record- ✓Age 4 through 18 years
- ✓Healthy subject meeting all inclusion criteria and none of the exclusion criteria
- ✓Signed informed consent from parent/legal guardian with subject assent if age ≥7 years
- ✕History of hypersensitivity or anaphylactic reaction to FluMist™ components, including eggs or egg products
- ✕On aspirin therapy or aspirin-containing therapy
- ✕History of Guillain-Barré syndrome
- ✕Known or suspected immune deficiency diseases or conditions such as HIV, malignancy, leukemia, or lymphoma
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 4, School-based, Open-labeled Research Trial for Control of Epidemic Influenza Through a School-based Influenza Vaccination Program in Central Texas.
In Brief
A Phase 4 clinical trial evaluating live attenuated and inactivated influenza vaccines for Influenza. Completed, enrolled 29,255 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
Live Attenuated Influenza Vaccine (LAIV) and Inactivated Influenza Vaccine (IIV) were administered to eligible children through a research program to improve vaccination coverage in school-aged children. Children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) will be offered LAIV or IIV through a school-based research vaccination program. Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites received LAIV or IIV from the local healthcare providers