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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00961337
Other study ID # DOH97-DC-2003
Secondary ID
Status Completed
Phase Phase 4
First received August 10, 2009
Last updated August 17, 2009
Start date October 2008
Est. completion date May 2009

Study information

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

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
Trivalent inactivated influenza vaccine
one dose

Locations

Country Name City State
Taiwan Centers for Disease Control, Taiwan Taipei City

Sponsors (3)

Lead Sponsor Collaborator
Centers for Disease Control, Taiwan Education Department,Taoyan County Governmnet, Taiwan, Public Health Bureau,Taoyan County Governmnet, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

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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