Evaluation of a School-based Influenza Vaccination Program

NCT ID: NCT00961337

Last Updated: 2009-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

7854 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza Influenza Vaccines

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vaccination township

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

Group Type EXPERIMENTAL

Trivalent inactivated influenza vaccine

Intervention Type BIOLOGICAL

one dose

Control townships

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Trivalent inactivated influenza vaccine

one dose

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Brand Name: VAXIGRIP

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Public Health Bureau,Taoyan County Governmnet, Taiwan

UNKNOWN

Sponsor Role collaborator

Education Department,Taoyan County Governmnet, Taiwan

OTHER

Sponsor Role collaborator

Centers for Disease Control, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Centers for Disease Control, Department of Health,Taiwan, R.O.C.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jen-Hsiang Chunag, MD, MS, PhD.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centers for Disease Control, Taiwan

Taipei, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DOH97-DC-2003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study of a Flu Vaccine in Children
NCT00001127 COMPLETED PHASE3
A/H5N1 Vaccine in Healthy Children Aged 2-9 Years
NCT00133536 COMPLETED PHASE1/PHASE2