Influenza Clinical Trial
Official title:
Phase 4, School-based, Open-labeled Research Trial for Control of Epidemic Influenza Through a School-based Influenza Vaccination Program in Central Texas.
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.
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: 17698577). The final phase of the study spanned 2007-2011 and is the
scope of this submission.
The goal of the final phase is to control epidemic influenza through active immunization of
healthy school-aged children with the cold-adapted, trivalent, live, attenuated influenza
vaccine (LAIV) and at-risk children with the inactivated influenza vaccine (IIV) through a
school-based vaccination program.
The hypothesis is that universal vaccination of healthy school-aged children is an
alternative and effective strategy for the control of epidemic influenza, and will serve as
a model for the control of pandemic influenza and biodefense. The specific aims of the study
are: to control the spread of influenza to susceptible adults 35 years of age or older by
vaccination of school-aged children 4-18 years of age; to control the spread of influenza to
susceptible children and young adults less than 35 years of age by vaccination of
school-aged children 4-18 years of age; to develop a school-based vaccination program for
rapid and timely delivery of LAIV and IIV to children 4-18 years of age; to demonstrate in
school-aged children the direct and total effectiveness of influenza vaccines to reduce the
rates of medically attended acute respiratory illness (MAARI) in LAIV and IIV recipients
during influenza epidemics; and to capture safety information on LAIV post-licensure.
This is an open-label, up to four year community-based study. In each of the first three
study years, school-aged children (4 through 18 years of age) who receive medical care at
the Scott & White Clinics (SWCs), Temple-Belton area, Texas, will be asked to participate in
this study. Study participants will receive LAIV or IIV according to their health status.
Other children from Temple-Belton area who do not receive medical care at the SWC will be
invited to participate in the study and may receive LAIV or IIV. A comparable population
enrolled in the SWCs in Waco/McLennan County area and Bryan/College Station will serve as
comparison groups.
In the fourth and final year of the study, LAIV will not be provided through the study.
However, influenza surveillance will continue and MAARI data will be collected to assess
continued protective benefit of influenza vaccines. The final year will also be devoted to
completion of data analysis and preparation of manuscripts.
Children 4 years through 8 years who have not previously been vaccinated with an influenza
vaccine will be offered a second dose 4 to 6 weeks after the first dose. The influenza
vaccines will contain the three influenza virus strains chosen by the FDA. Each subject will
receive by nasal spray a 0.2 ml dose (0.1 ml in each nostril) of the LAIV or 0.5 ml
intramuscularly.
The duration of each study year is approximately five to ten months, from the time of
enrollment (August to January, at the discretion of the investigators) depending on vaccine
availability and the timing of influenza activity, to the end of the influenza season (May).
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