- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00961337
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
-
-
-
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.
|
one dose
Other Names:
|
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.
Collaborators
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.
Clinical Trials on Influenza
-
Novartis VaccinesCompletedInfluenza | Seasonal Influenza | Human Influenza | Influenza Due to Unspecified Influenza VirusBelgium
-
Gamaleya Research Institute of Epidemiology and...CompletedInfluenza A | Influenza A Virus Infection | Influenza Epidemic | Influenza H5N1Russian Federation
-
Vanderbilt University Medical CenterHuman Vaccines ProjectCompletedVaccine Reaction | Influenza | Influenza, Human | Influenza A | Influenza Type B | Influenza A H3N2 | Influenza A H1N1United States
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza Immunisation | Avian InfluenzaUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza | Avian Influenza | H1N1 InfluenzaUnited States
-
National Institute of Allergy and Infectious Diseases...University of Oxford; Wellcome Trust; World Health OrganizationCompletedInfluenza | Avian Influenza | Severe InfluenzaSingapore, Thailand, Vietnam
-
National Institute of Allergy and Infectious Diseases...Completed
-
National Institute of Allergy and Infectious Diseases...Completed
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza Immunisation | Avian InfluenzaUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza | Influenza Immunisation | Avian InfluenzaUnited States
Clinical Trials on Trivalent inactivated influenza vaccine
-
SanofiCompletedInfluenza | Myxovirus InfectionUnited States
-
British Columbia Centre for Disease ControlUnknown
-
University Health Network, TorontoCompletedLung Transplantation | Influenza VaccinesCanada
-
University of RochesterUniversity of Miami; Wake Forest University Health Sciences; University of Texas... and other collaboratorsCompleted
-
Johns Hopkins Bloomberg School of Public HealthCompletedInfluenza Virus VaccineUnited States
-
Vanderbilt UniversityUniversity of Pittsburgh; MCM Vaccines B.V.CompletedPediatric Solid Organ Transplant PatientsUnited States
-
Vanderbilt UniversityCompletedPediatric Patients With Acute Lymphoblastic LeukemiaUnited States
-
SeqirusCompletedInfluenzaUnited Kingdom
-
Wayne Sullender, M.D.All India Institute of Medical Sciences, New Delhi; Centers for Disease Control...Completed
-
University of Witwatersrand, South AfricaBill and Melinda Gates FoundationCompletedInfluenza | Human Immunodeficiency VirusSouth Africa