NCT00961337

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,854

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2009

Completed
Last Updated

August 18, 2009

Status Verified

August 1, 2009

Enrollment Period

5 months

First QC Date

August 10, 2009

Last Update Submit

August 17, 2009

Conditions

InfluenzaInfluenza Vaccines

Keywords

school childreninfluenza vaccinationvaccine effectivenessinfluenza attack rateabsenteeismInfluenza vaccine

Outcome Measures

Primary Outcomes (1)

  • Influenza attack rate

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

Secondary Outcomes (3)

  • Children's absenteeism

    before and after week 38, 2008

  • Vaccine effectiveness

    From November, 2008 to February, 2009

  • Side effects after vaccination

    within one week after vaccination

Study Arms (2)

Vaccination township

EXPERIMENTAL

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

Biological: Trivalent inactivated influenza vaccine

Control townships

NO INTERVENTION

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

Interventions

Trivalent inactivated influenza vaccineBIOLOGICAL

one dose

Also known as: Brand Name: VAXIGRIP
Vaccination township

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • One junior high school in Shinwu township because it had both high school and junior high school

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centers for Disease Control, Taiwan

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Jen-Hsiang Chunag, MD, MS, PhD.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 10, 2009

First Posted

August 18, 2009

Study Start

October 1, 2008

Primary Completion

March 1, 2009

Study Completion

May 1, 2009

Last Updated

August 18, 2009

Record last verified: 2009-08

Locations

TW(1)