Evaluation of a School-based Influenza Vaccination Program

August 17, 2009 updated by: Centers for Disease Control, Taiwan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7854

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei City, Taiwan, 100
        • Centers for Disease Control, Taiwan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control, Taiwan

Collaborators

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

Investigators

  • Principal Investigator: Jen-Hsiang Chunag, MD, MS, PhD., National Health Command Center, Centers for disease control, Department of Health, Taiwan, R.O.C

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

August 10, 2009

First Submitted That Met QC Criteria

August 17, 2009

First Posted (Estimate)

August 18, 2009

Study Record Updates

Last Update Posted (Estimate)

August 18, 2009

Last Update Submitted That Met QC Criteria

August 17, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOH97-DC-2003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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