|
|
View Clinical Trial (Medical Research Study)
|
Flumist & Herd Immunity for Flu Control - NCT00138294-76508 (Clinical Trial 127593)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy127593.aspx
|
** Please review additional "Nearby Studies" on right ----->
This is an archived study that is no longer available, if you
would like to find active studies please
search our studies.
|
|
 |
 |
|
| City: |
|
Temple |
|
State:
|
|
TX |
| Zip Code: |
|
76508 |
| Conditions: |
|
Influenza |
| Purpose: |
|
The main purpose of this study is to learn if the vaccine FluMist, when given to school-aged
children 5 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 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 summary: |
|
In this renewal application, the study goal is to control epidemic influenza through active
immunization of school-aged children with the cold-adapted, trivalent, live, attenuated
influenza vaccine (LAIV). 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 5-18 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 5-18 years of age; to develop a school-based
vaccination program for rapid and timely delivery of LAIV to children 5-18 years of age; to
demonstrate in school-aged children the direct and total effectiveness of LAIV to reduce the
rates of medically attended acute respiratory illness (MAARI) in LAIV recipients during
influenza epidemics; and to capture safety information on LAIV post-licensure. This is an
open-label, four year community-based study. In each of the first three study years,
school-aged children (5 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 the LAIV. 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
the LAIV. 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 LAIV.
The final year will also be devoted to completion of data analysis and preparation of
manuscripts. Children 5 years through 8 years who have not previously been vaccinated with
FluMist will be offered a second dose 6 to 10 weeks after the first dose. The LAIV will
contain the three influenza virus strains that have been shown to induce antibodies against
those chosen by the FDA. Each subject will receive by nasal spray a 0.5 ml dose (0.25 ml in
each nostril) of the LAIV. 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). |
| 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, 5 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 |
|
|
|
|
|
|
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
February 15, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|
|
|
|