Influenza Clinical Trial
Official title:
Evaluation of a School-based Influenza Vaccination Program
Verified date | August 2009 |
Source | Centers for Disease Control, Taiwan |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 7854 |
Est. completion date | May 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Years to 16 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Taiwan | Centers for Disease Control, Taiwan | Taipei City |
Lead Sponsor | Collaborator |
---|---|
Centers for Disease Control, Taiwan | Education Department,Taoyan County Governmnet, Taiwan, Public Health Bureau,Taoyan County Governmnet, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Influenza attack rate | Three time points: November, December, 2008; February, 2009 | No | |
Secondary | Children's absenteeism | before and after week 38, 2008 | No | |
Secondary | Vaccine effectiveness | From November, 2008 to February, 2009 | No | |
Secondary | Side effects after vaccination | within one week after vaccination | Yes |
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