InfluenzaPhase 4NCT00961337
Evaluation of a School-based Influenza Vaccination Program
A Phase 4 study testing Trivalent inactivated influenza vaccine in people with Influenza and Influenza Vaccines, run by Centers for Disease Control, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Influenza Vaccines
- What is being tested?
- Trivalent inactivated influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,854 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2008to May 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- One junior high school in Shinwu township because it had both high school and junior high school
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Influenza, Influenza Vaccines
- Being tested
- Trivalent inactivated influenza vaccine
- Keywords
- school children, influenza vaccination, vaccine effectiveness, influenza attack rate, absenteeism, Influenza vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent inactivated influenza vaccineBiological
Also called Brand Name: VAXIGRIP
one dose
| Study group | Role | What they receive |
|---|---|---|
| Vaccination township | Experimental | Shinwu township was randomly designated as intervention township which freely vaccinated on grade 1-4 and 5-9 students. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influenza attack rate
Measured: Three time points: November, December, 2008; February, 2009
Secondary outcomes (3)
Children's absenteeism
Measured: before and after week 38, 2008
Vaccine effectiveness
Measured: From November, 2008 to February, 2009
Side effects after vaccination
Measured: within one week after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startOct 2008
- Primary completionMar 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,854 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control, Taiwan
- Sponsor type
- Other government
- Collaborators
- Public Health Bureau,Taoyan County Governmnet, Taiwan, Education Department,Taoyan County Governmnet, Taiwan
- Investigators
- Jen-Hsiang Chunag, MD, MS, PhD., Principal investigator, National Health Command Center, Centers for disease control, Department of Health, Taiwan, R.O.C
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961337
- Sponsor's protocol ID
- DOH97-DC-2003
- Status last verified
- Aug 2009
- First submitted
- 10 Aug 2009
- Last updated
- 18 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a School-based Influenza Vaccination Program
- ClinicalTrials.gov ID
- NCT00961337
- Acronym / sponsor ID
- DOH97-DC-2003
- Conditions
- Influenza, Influenza Vaccines
- Keywords
- school children, influenza vaccination, vaccine effectiveness, influenza attack rate, absenteeism, Influenza vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,854 participants (actual)
- Lead sponsor
- Centers for Disease Control, TaiwanOther government
- Collaborators
- Public Health Bureau,Taoyan County Governmnet, Taiwan, Education Department,Taoyan County Governmnet, Taiwan
- Study start
- Oct 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 18 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccination township | Experimental | Biological: Trivalent inactivated influenza vaccineShinwu township was randomly designated as intervention township which freely vaccinated on grade 1-4 and 5-9 students. |
| Control townships | No intervention | –Guanyin township was designated as control township which only provide free vaccination on grade 1-4 students. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- One junior high school in Shinwu township because it had both high school and junior high school
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trivalent inactivated influenza vaccineAlso: Brand Name: VAXIGRIPone dose | Biological | Vaccination township |
Primary outcome
Influenza attack rate
Time frame: Three time points: November, December, 2008; February, 2009
3 secondary outcomes
Children's absenteeism
Time frame: before and after week 38, 2008
Vaccine effectiveness
Time frame: From November, 2008 to February, 2009
Side effects after vaccination
Time frame: within one week after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jen-Hsiang Chunag, MD, MS, PhD. principal investigator
National Health Command Center, Centers for disease control, Department of Health, Taiwan, R.O.C
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trivalent inactivated influenza vaccine in people with Influenza and Influenza Vaccines, run by Centers for Disease Control, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influenza attack rate (time frame: Three time points: November, December, 2008; February, 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2009.