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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Influenza	Biological: live attenuated and inactivated influenza vaccines	Phase 4

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 Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	29255 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
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.
Actual Study Start Date :	October 1998
Actual Primary Completion Date :	June 2010
Actual Study Completion Date :	June 2010

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.	Biological: live attenuated and inactivated influenza vaccines; 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: FluMist; Fluzone
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.	Biological: live attenuated and inactivated influenza vaccines; 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: FluMist; Fluzone

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. MAARI Rate During the Epidemic Period (2007-2008) [ Time Frame: 12/16/2007 to 3/29/2008 (15 weeks) ]
   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.
2. MAARI Rate During the Epidemic Period (2008-2009) [ Time Frame: 1/4/2009 to 3/21/2009 (11 weeks) ]
   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.
3. MAARI Rate During the Epidemic and Pandemic Period (2009-2010) [ Time Frame: 8/25/09 to 4/3/10 (32 weeks) ]
   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.

Secondary Outcome Measures :

1. Proportion of SAEs Detected in LAIV Recipients [ Time Frame: pre-, post- influenza vaccination ]
   Serious adverse events (SAEs) within 42 days post-LAIV vaccination will be captured in seasonal and pandemic vaccinated study subjects.

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	4 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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, 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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Texas
Scott & White Hospital and Clinic
Temple, Texas, United States, 76508
Scott & White Hospital and Clinic
Waco, Texas, United States, 76710

Sponsors and Collaborators

Baylor College of Medicine

Scott and White Hospital & Clinic

Novartis

Sanofi Pasteur, a Sanofi Company

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator:	Pedro A Piedra, MD	Baylor College of Medicine

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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. 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Pedro Piedra, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00138294 History of Changes
Other Study ID Numbers:	BCM H-21853; Flu-035-09 ( Other Identifier: MedImmune Inc ); BCM H-21853 ( Other Identifier: Baylor College of Medicine ); SW070912 ( Other Identifier: Scott and White ); R01AI041050 ( U.S. NIH Grant/Contract )
First Posted:	August 30, 2005
Results First Posted:	May 19, 2017
Last Update Posted:	May 19, 2017
Last Verified:	May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No
Product Manufactured in and Exported from the U.S.:		No

Keywords provided by Pedro Piedra, Baylor College of Medicine:

influenza vaccine; live attenuated influenza vaccine (LAIV or FluMist); inactivated influenza vaccine (IIV)	School-based influenza vaccination program; children; herd protection

Additional relevant MeSH terms:

Influenza, Human; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections	Respiratory Tract Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs