Control of Epidemic Influenza Through a School-based Influenza Vaccination Program (CEI)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2010 by Baylor College of Medicine.
Recruitment status was Active, not recruiting

Sponsor:

Collaborators:

Scott and White Hospital & Clinic

Novartis

Sanofi Pasteur MSD

Information provided by:

Baylor College of Medicine

ClinicalTrials.gov Identifier:

NCT00138294

First received: August 26, 2005

Last updated: March 4, 2010

Last verified: March 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	August 26, 2005
Last Updated Date	March 4, 2010
Start Date ^ICMJE	October 2003
Estimated Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 4, 2010)	Effectiveness [ Time Frame: pre-, post- and the influenza outbreak periods ] [ Designated as safety issue: No ] Age-specific rates for medically attended acute respiratory illness (MAARI) in the pre-, post- and the influenza outbreak periods will be calculated for the intervention and comparison communities. Overall effectiveness will be evaluated in the intervention communities. Overall effectiveness will compare age-specific MAARI rates during the influenza outbreak for SWHP members in the intervention and comparison communities, irrespective of influenza vaccination status.
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00138294 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 4, 2010)	Effectiveness and safety [ Time Frame: pre-, post- and the influenza outbreak periods ] [ Designated as safety issue: Yes ] Age-specific rates for MAARI and P&I will be determined in seasonal (CAIV-T and IIV-T) and pandemic SWHP student vaccinees compared to age-eligible SWHP non-participants who had never received seasonal (CAIV-T or IIV-T) or pandemic influenza vaccine in the intervention communities (direct effectiveness) and comparison communities (total effectiveness). Serious adverse events (SAEs) and MAARI adverse events within 42 days post vaccination will be captured in seasonal (CAIV-T and IIV-T) and pandemic vaccinated study subjects.
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Control of Epidemic Influenza Through a School-based Influenza Vaccination Program
Official Title ^ICMJE	Phase 4, School-based, Open-labeled Research Trial for Control of Epidemic Influenza Through a School-based Influenza Vaccination Program in Central Texas.
Brief 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.
Detailed Description	In this renewal application (2008-2012), the study goal 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 ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Influenza
Intervention ^ICMJE	Biological: influenza vaccine live attenuated influenza vaccine (FluMist); 0.2 ml intranasal dose inactivated influenza vaccine, 0.5 ml intramuscular injection Other Names: FluMist Fluzone Biological: Live attenuated influenza vaccine and inactivated influenza vaccine live attenuated influenza vaccine; 0.2 ml intranasal dose, 0.1 ml to each nostril inactivated influenza vaccine; 0.5 ml dose by intramuscular injection Other Names: FluMist Fluzone
Study Arm (s)	Active Comparator: influenza vaccine 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 vaccination program. 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 by the local healthcare providers Interventions: Biological: influenza vaccine Biological: Live attenuated influenza vaccine and inactivated influenza vaccine
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. 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. 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. 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. 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. 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. 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. 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. Epub 2010 Oct 28.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	12000
Estimated Completion Date	December 2011
Estimated Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	4 Years to 18 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00138294
Other Study ID Numbers ^ICMJE	BCM H-21853, Flu-035-09, BCM H-21853, SW070912, R01 AI041050 (ended 31Jan2009)
Has Data Monitoring Committee	Yes
Responsible Party	Pedro A. Piedra, M.D., Baylor College of Medicine
Study Sponsor ^ICMJE	Baylor College of Medicine
Collaborators ^ICMJE	Scott and White Hospital & Clinic Novartis Sanofi Pasteur MSD
Investigators ^ICMJE	Not Provided
Information Provided By	Baylor College of Medicine
Verification Date	March 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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