Influenza Clinical Trial
— CEIOfficial title:
Phase 4, School-based, Open-labeled Research Trial for Control of Epidemic Influenza Through a School-based Influenza Vaccination Program in Central Texas.
Verified date | May 2017 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 29255 |
Est. completion date | June 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 18 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Scott & White Hospital and Clinic | Temple | Texas |
United States | Scott & White Hospital and Clinic | Waco | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine | National Institute of Allergy and Infectious Diseases (NIAID), Novartis, Sanofi Pasteur, a Sanofi Company, Scott and White Hospital & Clinic |
United States,
Gaglani MJ, Piedra PA, Herschler GB, Griffith ME, Kozinetz CA, Riggs MW, Fewlass C, Halloran ME, Longini IM Jr, Glezen WP. Direct and total effectiveness of the intranasal, live-attenuated, trivalent cold-adapted influenza virus vaccine against the 2000-2 — View Citation
Gaglani MJ, Piedra PA, Riggs M, Herschler G, Fewlass C, Glezen WP. Safety of the intranasal, trivalent, live attenuated influenza vaccine (LAIV) in children with intermittent wheezing in an open-label field trial. Pediatr Infect Dis J. 2008 May;27(5):444- — View Citation
Halloran ME, Longini IM Jr, Gaglani MJ, Piedra PA, Chu H, Herschler GB, Glezen WP. Estimating efficacy of trivalent, cold-adapted, influenza virus vaccine (CAIV-T) against influenza A (H1N1) and B using surveillance cultures. Am J Epidemiol. 2003 Aug 15;1 — View Citation
Halloran ME, Piedra PA, Longini IM Jr, Gaglani MJ, Schmotzer B, Fewlass C, Herschler GB, Glezen WP. Efficacy of trivalent, cold-adapted, influenza virus vaccine against influenza A (Fujian), a drift variant, during 2003-2004. Vaccine. 2007 May 16;25(20):4 — View Citation
Piedra PA, Gaglani MJ, Kozinetz CA, Herschler G, Riggs M, Griffith M, Fewlass C, Watts M, Hessel C, Cordova J, Glezen WP. Herd immunity in adults against influenza-related illnesses with use of the trivalent-live attenuated influenza vaccine (CAIV-T) in c — View Citation
Piedra PA, Gaglani MJ, Kozinetz CA, Herschler GB, Fewlass C, Harvey D, Zimmerman N, Glezen WP. Trivalent live attenuated intranasal influenza vaccine administered during the 2003-2004 influenza type A (H3N2) outbreak provided immediate, direct, and indire — View Citation
Piedra PA, Gaglani MJ, Riggs M, Herschler G, Fewlass C, Watts M, Kozinetz C, Hessel C, Glezen WP. Live attenuated influenza vaccine, trivalent, is safe in healthy children 18 months to 4 years, 5 to 9 years, and 10 to 18 years of age in a community-based, — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MAARI Rate During the Epidemic Period (2007-2008) | The rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). This data was obtained from the SWHP database. | 12/16/2007 to 3/29/2008 (15 weeks) | |
Primary | MAARI Rate During the Epidemic Period (2008-2009) | The rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). This data was obtained from the SWHP database. | 1/4/2009 to 3/21/2009 (11 weeks) | |
Primary | MAARI Rate During the Epidemic and Pandemic Period (2009-2010) | The rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). This data was obtained from the SWHP database. | 8/25/09 to 4/3/10 (32 weeks) | |
Secondary | Proportion of SAEs Detected in LAIV Recipients | Serious adverse events (SAEs) within 42 days post-LAIV vaccination will be captured in seasonal and pandemic vaccinated study subjects. | pre-, post- influenza vaccination |
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