- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00138294
Control of Epidemic Influenza Through a School-based Influenza Vaccination Program (CEI)
Phase 4, School-based, Open-labeled Research Trial for Control of Epidemic Influenza Through a School-based Influenza Vaccination Program in Central Texas.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Texas
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Temple, Texas, United States, 76508
- Scott & White Hospital and Clinic
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Waco, Texas, United States, 76710
- Scott & White Hospital and Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Cities
Children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) with be offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program.
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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
Other Names:
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Active Comparator: Comparison Cities
Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites will received their influenza vaccines (live attenuated or inactivated influenza vaccines) by the local healthcare providers.
|
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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MAARI Rate During the Epidemic Period (2007-2008)
Time Frame: 12/16/2007 to 3/29/2008 (15 weeks)
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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.
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12/16/2007 to 3/29/2008 (15 weeks)
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MAARI Rate During the Epidemic Period (2008-2009)
Time Frame: 1/4/2009 to 3/21/2009 (11 weeks)
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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.
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1/4/2009 to 3/21/2009 (11 weeks)
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MAARI Rate During the Epidemic and Pandemic Period (2009-2010)
Time Frame: 8/25/09 to 4/3/10 (32 weeks)
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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.
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8/25/09 to 4/3/10 (32 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of SAEs Detected in LAIV Recipients
Time Frame: pre-, post- influenza vaccination
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Serious adverse events (SAEs) within 42 days post-LAIV vaccination will be captured in seasonal and pandemic vaccinated study subjects.
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pre-, post- influenza vaccination
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Pedro A Piedra, MD, Baylor College of Medicine
Publications and helpful links
General Publications
- 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):444-52. doi: 10.1097/INF.0b013e3181660c2e.
- 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 indirect protection in children. Pediatrics. 2007 Sep;120(3):e553-64. doi: 10.1542/peds.2006-2836. Epub 2007 Aug 13.
- 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):4038-45. doi: 10.1016/j.vaccine.2007.02.060. Epub 2007 Mar 12.
- 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, nonrandomized, open-label trial. Pediatrics. 2005 Sep;116(3):e397-407. doi: 10.1542/peds.2004-2258.
- 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 children. Vaccine. 2005 Feb 18;23(13):1540-8. doi: 10.1016/j.vaccine.2004.09.025.
- 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 2000-2001 influenza A(H1N1) and B epidemic in healthy children. Arch Pediatr Adolesc Med. 2004 Jan;158(1):65-73. doi: 10.1001/archpedi.158.1.65.
- 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;158(4):305-11. doi: 10.1093/aje/kwg163.
- Glezen WP, Gaglani MJ, Kozinetz CA, Piedra PA. Direct and indirect effectiveness of influenza vaccination delivered to children at school preceding an epidemic caused by 3 new influenza virus variants. J Infect Dis. 2010 Dec 1;202(11):1626-33. doi: 10.1086/657089. Epub 2010 Oct 28.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCM H-21853 (Other Identifier: Baylor College of Medicine)
- Flu-035-09 (Other Identifier: MedImmune Inc)
- SW070912 (Other Identifier: Scott and White)
- R01AI041050 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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