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Evaluation of a School-based Influenza Vaccination Program

Primary Purpose

Influenza, Influenza Vaccines

Status

Completed

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

Trivalent inactivated influenza vaccine

About this trial

This is an interventional prevention trial for Influenza focused on measuring school children, influenza vaccination, vaccine effectiveness, influenza attack rate, absenteeism, Influenza vaccine

Eligibility Criteria

6 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Centers for Disease Control, Taiwan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Vaccination township

Control townships

Arm Description

Shinwu township was randomly designated as intervention township which freely vaccinated on grade 1-4 and 5-9 students.

Guanyin township was designated as control township which only provide free vaccination on grade 1-4 students.

Outcomes

Primary Outcome Measures

Influenza attack rate

Secondary Outcome Measures

Children's absenteeism

Vaccine effectiveness

Side effects after vaccination

Full Information

NCT ID

NCT00961337

First Posted

August 10, 2009

Last Updated

August 17, 2009

Sponsor

Centers for Disease Control, Taiwan

Collaborators

Public Health Bureau,Taoyan County Governmnet, Taiwan, Education Department,Taoyan County Governmnet, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT00961337

Brief Title

Evaluation of a School-based Influenza Vaccination Program

Official Title

Evaluation of a School-based Influenza Vaccination Program

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Centers for Disease Control, Taiwan

Collaborators

Public Health Bureau,Taoyan County Governmnet, Taiwan, Education Department,Taoyan County Governmnet, Taiwan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza, Influenza Vaccines

Keywords

school children, influenza vaccination, vaccine effectiveness, influenza attack rate, absenteeism, Influenza vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

7854 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vaccination township

Arm Type

Experimental

Arm Description

Shinwu township was randomly designated as intervention township which freely vaccinated on grade 1-4 and 5-9 students.

Arm Title

Control townships

Arm Type

No Intervention

Arm Description

Guanyin township was designated as control township which only provide free vaccination on grade 1-4 students.

Intervention Type

Biological

Intervention Name(s)

Trivalent inactivated influenza vaccine

Other Intervention Name(s)

Brand Name: VAXIGRIP

Intervention Description

one dose

Primary Outcome Measure Information:

Title

Influenza attack rate

Time Frame

Three time points: November, December, 2008; February, 2009

Secondary Outcome Measure Information:

Title

Children's absenteeism

Time Frame

before and after week 38, 2008

Title

Vaccine effectiveness

Time Frame

From November, 2008 to February, 2009

Title

Side effects after vaccination

Time Frame

within one week after vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jen-Hsiang Chunag, MD, MS, PhD.

Organizational Affiliation

National Health Command Center, Centers for disease control, Department of Health, Taiwan, R.O.C

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centers for Disease Control, Taiwan

City

Taipei City

ZIP/Postal Code

100

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

Evaluation of a School-based Influenza Vaccination Program

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