Overview

This trial is active, not recruiting.

Condition influenza
Treatments influenza vaccine, live attenuated influenza vaccine and inactivated influenza vaccine
Phase phase 4
Sponsor Baylor College of Medicine
Collaborator Scott and White Hospital & Clinic
Start date October 2003
End date May 2011
Trial size 12000 participants
Trial identifier NCT00138294, BCM H-21853, Flu-035-09, R01 AI041050 (ended 31Jan2009), SW070912

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
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
influenza vaccine FluMist
live attenuated influenza vaccine (FluMist); 0.2 ml intranasal dose inactivated influenza vaccine, 0.5 ml intramuscular injection
live attenuated influenza vaccine and inactivated influenza vaccine FluMist
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

Primary Outcomes

Measure
Effectiveness
time frame: pre-, post- and the influenza outbreak periods

Secondary Outcomes

Measure
Effectiveness and safety
time frame: pre-, post- and the influenza outbreak periods

Eligibility Criteria

Male or female participants from 4 years up to 18 years old.

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

Additional Information

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.
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).
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by Baylor College of Medicine.