Evaluation of a School-based Influenza Vaccination Program

Influenza Clinical Trial

Official title:

Evaluation of a School-based Influenza Vaccination Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00961337
• Other study ID #: DOH97-DC-2003
• 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

• Influenza
• Influenza Vaccines
• Influenza, Human

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