Vaccination; InfectionNCT06048406
Effect of Health Education on Promoting Influenza Vaccination Health Literacy
A study testing Health education in people with Vaccination; Infection and Influenza, run by Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this cluster randomized controlled trial is to evaluate the effect of health education interventions on influenza vaccination rates and health literacy in primary school students in the city of Dongguan in China. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Vaccination; Infection, Influenza
- What is being tested?
- Health education
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,036 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2023to 30 Jun 2024
- Phase
- Interventional
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Primary school students within the age range of 7-12 years.
- Students and their parents who voluntarily agree to participate in the study and provide signed informed consent.
- Permanent residents of Dongguan City who are expected to complete the project without transferring schools during the study period.
Who cannot join
- Individuals with contraindications to influenza vaccination, who have recently received an influenza vaccination, diagnosed with influenza or confirmed as influenza-like cases at the commencement of the study.
- Unwilling to participate in the project.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dongguang Center for Disease Control and Prevention
Dongzhoucun, Guangdong, 510000
Lin Xu, PhD, +8613602477650, xulin27@mail.sysu.edu.cn
About this study
Official title: Effect of Health Education on Promoting Influenza Vaccination Health Literacy Among Primary School Students
The goal of this cluster randomized controlled trial is to evaluate the effect of health education interventions on influenza vaccination rates and health literacy in primary school students in the city of Dongguan in China.
Individuals aged 7 to 12 years who are in grades 4-5 in primary schools in Dongguan will be enrolled. 20 primary schools will be randomly selected, with half designated as intervention group schools and the remaining half as control group schools. The intervention group will receive a monthly health education intervention focused on influenza vaccination for 5 months, while the control group will continue with their routine school health education for 5 months.
Researchers will compare the differences in influenza vaccination rates and influenza vaccination health literacy levels between the intervention and control groups after 5 months to see if health education can promote influenza vaccination health literacy among primary school students.
Read the detailed description
Introduction: Influenza is a major public health threat, and vaccination is the most effective prevention method. However, vaccination coverage remains suboptimal. Low health literacy regarding influenza vaccination may contribute to vaccine hesitancy. This study aims to evaluate the effect of health education interventions on influenza vaccination rates and health literacy.
Methods and analysis: This cluster randomized controlled trial will enroll 3036 students in grades 4-5 from 20 primary schools in Dongguan City, China. Schools will be randomized to an intervention group receiving influenza vaccination health education or a control group receiving routine health education. The primary outcome is influenza vaccination rate. Secondary outcomes include health literacy levels, influenza diagnosis rate, influenza-like illness incidence, and vaccine protection rate. Data will be collected through questionnaires, influenza surveillance, and self-reports at baseline and study conclusion.
Ethics and dissemination: Ethical approval has been sought from the Ethics Committee of the School of Public Health, Sun Yat-sen University. Findings from the study will be made accessible to both peer-reviewed journals and key stakeholders.
- Conditions
- Vaccination; Infection, Influenza
- Being tested
- Health education
- Keywords
- health education, health literacy, schools, China
- Medical subject headings
- Infections, Influenza, Human, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health educationCombination product
The intervention group will receive a health education intervention focused on influenza vaccination literacy, while the control group will continue with their standard school health education without any additional intervention. An influenza vaccination health education including topics such as the importance of influenza vaccination, benefits of vaccination, and vaccination methods, will be developed and reviewed by an expert group. The package for the intervention group will include educational activities, distribution of promotional materials, vaccination services, and distribution of vaccination souvenirs.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group will receive a monthly health education intervention focused on influenza vaccination literacy for 5 months. Receives: Combination Product: Health education |
| Control | No intervention | The control group will continue with their routine school health education for 5 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
influenza vaccination rate
he influenza vaccination rate will be calculated as the number of vaccinated individuals divided by the total number of individuals, multiplied by 100%.
Measured: Within 20 weeks from enrollment
Secondary outcomes (4)
influenza vaccination health literacy level
Regarding the influenza vaccination health literacy level, each correct answer for the health literacy research questionnaire will be scored as one point, with incorrect answers receiving no points.
Measured: Within 20 weeks from enrollment
influenza incidence
The influenza incidence will be calculated as the number of individuals diagnosed with influenza divided by the total number of individuals, multiplied by 100%
Measured: Within 20 weeks from enrollment
influenza vaccine protection rate
The influenza vaccine protection rate will be calculated as the difference between the incidence rate in unvaccinated individuals and the incidence rate in vaccinated individuals, divided by the incidence rate in unvaccinated individuals, multiplied by 100%.
Measured: Within 20 weeks from enrollment
influenza-like illness incidence
The ILI incidence will be calculated as the number of ILI cases divided by the total number of participants, multiplied by 100%.
Measured: Within 20 weeks from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start11 Sep 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vaccination; InfectionStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,036 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Xu, Sun Yat-sen University
- Investigators
- Lin Xu, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048406
- Sponsor's protocol ID
- SunYat-senU20230908
- Status last verified
- Feb 2024
- First submitted
- 8 Sep 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen J, Xie W, Huang X, Huang A, Lu T, Zhang R, Xiao J, He S, Wang J, Xu L. Impact of multifaceted health education on influenza vaccination health literacy in primary school students: a cluster randomized controlled trial. BMC Med. 2025 Jun 4;23(1):333. doi: 10.1186/s12916-025-04156-1.
PubMed 40468328Xie W, Xiao J, Chen J, Huang H, Huang X, He S, Xu L. Impact of health education on promoting influenza vaccination health literacy in primary school students: a cluster randomised controlled trial protocol. BMJ Open. 2024 Apr 12;14(4):e080115. doi: 10.1136/bmjopen-2023-080115.
PubMed 38609315
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Health Education on Promoting Influenza Vaccination Health Literacy Among Primary School Students
- ClinicalTrials.gov ID
- NCT06048406
- Acronym / sponsor ID
- SunYat-senU20230908
- Conditions
- Vaccination; Infection, Influenza
- Keywords
- health education, health literacy, schools, China
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,036 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 21 Sep 2023 (actual)
- 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 goal of this cluster randomized controlled trial is to evaluate the effect of health education interventions on influenza vaccination rates and health literacy in primary school students in the city of Dongguan in China.
Individuals aged 7 to 12 years who are in grades 4-5 in primary schools in Dongguan will be enrolled. 20 primary schools will be randomly selected, with half designated as intervention group schools and the remaining half as control group schools. The intervention group will receive a monthly health education intervention focused on influenza vaccination for 5 months, while the control group will continue with their routine school health education for 5 months.
Researchers will compare the differences in influenza vaccination rates and influenza vaccination health literacy levels between the intervention and control groups after 5 months to see if health education can promote influenza vaccination health literacy among primary school students.
Detailed description
Introduction: Influenza is a major public health threat, and vaccination is the most effective prevention method. However, vaccination coverage remains suboptimal. Low health literacy regarding influenza vaccination may contribute to vaccine hesitancy. This study aims to evaluate the effect of health education interventions on influenza vaccination rates and health literacy.
Methods and analysis: This cluster randomized controlled trial will enroll 3036 students in grades 4-5 from 20 primary schools in Dongguan City, China. Schools will be randomized to an intervention group receiving influenza vaccination health education or a control group receiving routine health education. The primary outcome is influenza vaccination rate. Secondary outcomes include health literacy levels, influenza diagnosis rate, influenza-like illness incidence, and vaccine protection rate. Data will be collected through questionnaires, influenza surveillance, and self-reports at baseline and study conclusion.
Ethics and dissemination: Ethical approval has been sought from the Ethics Committee of the School of Public Health, Sun Yat-sen University. Findings from the study will be made accessible to both peer-reviewed journals and key stakeholders.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Combination Product: Health educationThe intervention group will receive a monthly health education intervention focused on influenza vaccination literacy for 5 months. |
| Control | No intervention | –The control group will continue with their routine school health education for 5 months. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Primary school students within the age range of 7-12 years.
- Students and their parents who voluntarily agree to participate in the study and provide signed informed consent.
- Permanent residents of Dongguan City who are expected to complete the project without transferring schools during the study period.
Key exclusion criteria (2 listed)
- Individuals with contraindications to influenza vaccination, who have recently received an influenza vaccination, diagnosed with influenza or confirmed as influenza-like cases at the commencement of the study.
- Unwilling to participate in the project.
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 |
|---|---|---|
| Health educationThe intervention group will receive a health education intervention focused on influenza vaccination literacy, while the control group will continue with their standard school health education without any additional intervention. An influenza vaccination health education including topics such as the importance of influenza vaccination, benefits of vaccination, and vaccination methods, will be developed and reviewed by an expert group. The package for the intervention group will include educational activities, distribution of promotional materials, vaccination services, and distribution of vaccination souvenirs. | Combination product | Intervention |
Primary outcome
influenza vaccination rate
Time frame: Within 20 weeks from enrollment
he influenza vaccination rate will be calculated as the number of vaccinated individuals divided by the total number of individuals, multiplied by 100%.
4 secondary outcomes
influenza vaccination health literacy level
Time frame: Within 20 weeks from enrollment
influenza incidence
Time frame: Within 20 weeks from enrollment
influenza vaccine protection rate
Time frame: Within 20 weeks from enrollment
influenza-like illness incidence
Time frame: Within 20 weeks from enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Derived from this study: PubMed 40468328Chen J, Xie W, Huang X, Huang A, Lu T, Zhang R, Xiao J, He S, Wang J, Xu L. Impact of multifaceted health education on influenza vaccination health literacy in primary school students: a cluster randomized controlled trial. BMC Med. 2025 Jun 4;23(1):333. doi: 10.1186/s12916-025-04156-1.
- Derived from this study: PubMed 38609315Xie W, Xiao J, Chen J, Huang H, Huang X, He S, Xu L. Impact of health education on promoting influenza vaccination health literacy in primary school students: a cluster randomised controlled trial protocol. BMJ Open. 2024 Apr 12;14(4):e080115. doi: 10.1136/bmjopen-2023-080115.
- Individual participant dataSharing planned: No
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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.
Lin Xu, PhD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education in people with Vaccination; Infection and Influenza, run by Sun Yat-sen University at 1 site in China.
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 2 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: status not confirmed, as of the sponsor's last update on 21 Feb 2024. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Xu, PhD (86-20-87335523, shellylxu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
influenza vaccination rate (time frame: Within 20 weeks from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06048406, which also lists 2 linked publications.
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 21 Feb 2024.