Evaluation of a School-based Influenza Vaccination Program

This study has been completed.
Sponsor:
Collaborators:
Public Health Bureau,Taoyan County Governmnet, Taiwan
Education Department,Taoyan County Governmnet, Taiwan
Information provided by:
Centers for Disease Control, Taiwan
ClinicalTrials.gov Identifier:
NCT00961337
First received: August 10, 2009
Last updated: August 17, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Influenza
Influenza Vaccines
Biological: Trivalent inactivated influenza vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of a School-based Influenza Vaccination Program

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control, Taiwan:

Primary Outcome Measures:
  • Influenza attack rate [ Time Frame: Three time points: November, December, 2008; February, 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Children's absenteeism [ Time Frame: before and after week 38, 2008 ] [ Designated as safety issue: No ]
  • Vaccine effectiveness [ Time Frame: From November, 2008 to February, 2009 ] [ Designated as safety issue: No ]
  • Side effects after vaccination [ Time Frame: within one week after vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 7854
Study Start Date: October 2008
Study Completion Date: May 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Brand Name: VAXIGRIP
No Intervention: Control townships
Guanyin township was designated as control township which only provide free vaccination on grade 1-4 students.

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.

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00961337

Locations
Taiwan
Centers for Disease Control, Taiwan
Taipei City, Taiwan, 100
Sponsors and Collaborators
Centers for Disease Control, Taiwan
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
  More Information

No publications provided

Responsible Party: Jen-Hsiang Chuang, Centers for Disease Control, Department of Health,Taiwan, R.O.C.
ClinicalTrials.gov Identifier: NCT00961337     History of Changes
Other Study ID Numbers: DOH97-DC-2003
Study First Received: August 10, 2009
Last Updated: August 17, 2009
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Centers for Disease Control, Taiwan:
school children
influenza vaccination
vaccine effectiveness
influenza attack rate
absenteeism
Influenza vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014