Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06048406
Other study ID # SunYat-senU20230908
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 11, 2023
Est. completion date June 30, 2024

Study information

Verified date February 2024
Source Sun Yat-sen University
Contact Lin Xu, PhD
Phone 86-20-87335523
Email shellylxu@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 3036
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 7 Years to 12 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
Health education
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.

Locations

Country Name City State
China Dongguang Center for Disease Control and Prevention Dongguang Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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%. Within 20 weeks from enrollment
Secondary 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. Within 20 weeks from enrollment
Secondary 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% Within 20 weeks from enrollment
Secondary 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%. Within 20 weeks from enrollment
Secondary 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%. Within 20 weeks from enrollment
See also
  Status Clinical Trial Phase
Completed NCT05523089 - The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults Phase 2
Completed NCT05009251 - Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake N/A
Completed NCT03282240 - Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US Phase 3
Completed NCT00971425 - Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1) Phase 3
Completed NCT00968526 - Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults Phase 3
Completed NCT00968539 - Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults Phase 3
Completed NCT05525494 - Patient Portal Flu Vaccine Reminders (5) N/A
Completed NCT04074928 - Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects Phase 3
Completed NCT04695717 - This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam Phase 3
Completed NCT05012163 - Lottery Incentive Nudges to Increase Influenza Vaccinations N/A
Completed NCT03888989 - Response to Influenza Vaccine During Pregnancy Phase 1
Completed NCT04109222 - Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively Phase 4
Completed NCT02587221 - Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age Phase 3
Completed NCT03453801 - The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection Phase 1
Completed NCT01440387 - A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older Phase 3
Terminated NCT01195779 - Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children Phase 2
Completed NCT03321968 - Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults Phase 3
Completed NCT00972517 - Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children Phase 3
Completed NCT04570904 - Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
Recruiting NCT03331991 - Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel N/A