Evaluation of a School-based Influenza Vaccination Program

Study Overview
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Brief Summary
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The purpose of this study is to determine whether inactivated influenza vaccines are effective to protect school children and their households from getting influenza infection and further prevent student's absenteeism.

Detailed Description
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School children were found to be the possible spreaders of the influenza. The successful prevention measure on school children was crucial for controlling the epidemic. In Taiwan, the national influenza immunization program on the grade 1-2 students started in winter, 2007. In this intervention study, the two study townships with 27 schools were included as our study population. The three time questionnaires were issued for collecting the health status of the children during the influenza season. The information on the vaccines' safety was also collected after the vaccination. The community collaborative clinics were responsible for taking the specimens.

Official Title
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Evaluation of a School-based Influenza Vaccination Program

Conditions
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Influenza, Influenza Vaccines

Intervention / Treatment
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* Biological: Trivalent inactivated influenza vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All elementary and junior high school students living in Shinwu and Guanyin townships were eligible to be enrolled into this study Agreed inform consent to participate in this study Complete three times questionaire follow-up Exclusion Criteria: One junior high school in Shinwu township because it had both high school and junior high school

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccination township<br>Shinwu township was randomly designated as intervention township which freely vaccinated on grade 1-4 and 5-9 students. | Biological: Trivalent inactivated influenza vaccine<br>* one dose<br>* Other names: Brand Name: VAXIGRIP;|
| No Intervention: Control townships<br>Guanyin township was designated as control township which only provide free vaccination on grade 1-4 students. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influenza attack rate |  | Three time points: November, December, 2008; February, 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's absenteeism |  | before and after week 38, 2008 | 
| Vaccine effectiveness |  | From November, 2008 to February, 2009 | 
| Side effects after vaccination |  | within one week after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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school children, influenza vaccination, vaccine effectiveness, influenza attack rate, absenteeism, Influenza vaccine