Control of Epidemic Influenza Through a School-based Influenza Vaccination Program

NCT00138294 | Completed Phase 4 Results DMC FDA Drug

• 4 other identifiers: BCM H-21853Flu-035-09SW070912R01AI041050
• Study Type: interventional
• Target: 29,255
• Locations: 1 country
• Sites: 2

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.

Conditions

Influenza

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (1)

• Proportion of SAEs Detected in LAIV Recipients

  pre-, post- influenza vaccination

Study Arms (2)

Intervention Cities

EXPERIMENTAL

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

Comparison Cities

ACTIVE COMPARATOR

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

Interventions

live attenuated and inactivated influenza vaccines BIOLOGICAL

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

Also known as: FluMist, Fluzone

Comparison Cities; Intervention Cities

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Scott and White Hospital & Clinic: collaborator
• Novartis: collaborator
• Sanofi Pasteur, a Sanofi Company: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (2)

Scott & White Hospital and Clinic

Temple, Texas, 76508, United States

Location

Scott & White Hospital and Clinic

Waco, Texas, 76710, United States

Location

Related Publications (8)

• 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.

  PMID: 18401289 RESULT

• 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.

  PMID: 17698577 RESULT

• 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.

  PMID: 17395338 RESULT

• 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.

  PMID: 16140685 RESULT

• 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.

  PMID: 15694506 RESULT

• 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.

  PMID: 14706961 RESULT

• 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.

  PMID: 12915495 RESULT

• 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.

  PMID: 21028955 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

FluMist; Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Pedro A Piedra, MD
• Organization: Baylor College of Medicine

ppiedra@bcm.edu

713-798-5240

Study Officials

• Pedro A Piedra, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: August 30, 2005
• Study Start: October 1, 1998
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 19, 2017
• Results First Posted: May 19, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)