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Completed

NCT Number: NCT00961337

Evaluation of a School-based Influenza Vaccination Program

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.

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Key information

Conditions

Influenza Infections Influenza Vaccines Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centers for Disease Control, Taiwan

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trivalent Inactivated Influenza Vaccine

Biological

one dose

Other names: Brand Name: VAXIGRIP

Primary outcomes

  1. Influenza attack rate

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

Secondary outcomes

  1. Children's absenteeism

    Time frame: before and after week 38, 2008

  2. Vaccine effectiveness

    Time frame: From November, 2008 to February, 2009

  3. Side effects after vaccination

    Time frame: within one week after vaccination

Sponsors and collaborators

Lead sponsor

Centers for Disease Control, Taiwan

Other Gov

Collaborators

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

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 18, 2009
Registry last updated
Aug 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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