Effect of Health Education on Promoting Influenza Vaccination Health Literacy Among Primary School Students
Phase: NA
Conditions: Vaccination; Infection, Influenza
Sponsor: Sun Yat-sen University

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Title: Effect of health education on promoting influenza vaccination health 
literacy among primary school students: a cluster randomized controlled trial 
protocol 
NCT number: NCT06048406 
Document date: 01 September 2023 
INTRODUCTION 
The Influenza virus, known for its mutability and potent infectivity, poses a 
significant health risk. Recent trends indicate an escalating incidence of influenza in 
China, thereby posing a substantial threat to public health.1, 2 According to national 
influenza surveillance data, each October marks the onset of the winter and spring 
influenza epidemic seasons across various regions in China.3, 4 Currently, the most 
effective preventative measure against influenza is vaccination.5 Seasonal influenza 
vaccinations have demonstrated efficacy in reducing the risk of influenza infection 
and severe complications across all age groups.6 Seasonal influenza epidemics often 
precipitate outbreaks in densely populated areas such as schools, childcare 
institutions, and nursing homes.6  
 
Health literacy, defined as an individual's capacity to acquire, comprehend, and utilize 
basic health information and services for informed health decisions, plays a pivotal 
role in vaccination uptake.7, 8 Enhancing vaccine health literacy can potentially 
augment vaccination willingness and mitigate vaccination hesitancy.9 Therefore, 
improving the population's awareness, attitudes, and behaviors towards influenza 
vaccination health literacy is integral to the successful implementation of influenza 

2 
 
prevention and control measures and strategy development. 
 
While numerous studies have investigated the broader implications of health 
education interventions on vaccination awareness and rates, there remains a distinct 
lack of focused research specifically targeting primary school students, especially 
within the context of China.10-12 The unique age group, characterized by their 
transitional cognitive abilities and susceptibility to influence, may respond differently 
to health literacy interventions than other age cohorts. Moreover, regional differences, 
cultural practices, and local health infrastructure in China might further impact the 
effectiveness of such interventions. Thus, this study aims to investigate the influence 
of health education on influenza vaccination rates and the level of influenza 
vaccination health literacy among fourth and fifth-grade primary school students. The 
methodological approach will involve a cluster randomized trial with schools serving 
as the unit of analysis. The findings will provide a scientific basis for future 
interventions. 
 
METHODS AND ANALYSIS 
Study objectives 
This study seeks to explore the impact of health education interventions on 
vaccination and influenza vaccination awareness among senior primary school 
students. By evaluating the impact of health education on the seasonal influenza 
vaccination rate and the level of influenza vaccination health literacy, we aim to 
provide a scientific foundation for regional influenza prevention and control 

3 
 
strategies. The specific objectives of this research are: 1) To ascertain the rate of 
influenza infection, the status of influenza vaccination, and the level of health literacy 
related to influenza vaccination among primary school students in Dongguan City. 2) 
To compare and contrast the influenza vaccination rate and the level of influenza 
vaccination health literacy between the experimental and control groups, thereby 
evaluating the impact of health education intervention on these parameters. 3) To 
assess the efficacy of influenza vaccine immunization among primary school students 
in Dongguan City. 
 
Study design  
The proposed study is a cluster randomized controlled trial. Two administrative 
districts, one in the central urban area and the other in the non-central urban area of 
Dongguan, will be selected for this study. Within each district, ten primary schools 
will be randomly selected, with half designated as intervention group schools and the 
remaining half as control group schools. This results in a total of twenty primary 
schools, evenly split between the intervention and control groups.  
 
The intervention group will receive a health education intervention focused on 
influenza vaccination, while the control group will continue with their routine school 
health education. The intervention period for this study is projected to last 
approximately three to four months. Data collection will conduct at the onset and 
conclusion of the intervention period. The primary outcomes of interest are the 
differences in influenza vaccination rates and influenza vaccination health literacy 
levels between the experimental and control groups, which will be used to evaluate 

4 
 
the effectiveness of the intervention. The overview of the study procedure is shown in 
the Figure 1.  
 
 
Study sample 
Study participants are primary school students in grades 4 to 5 in Dongguan City. 
Inclusion criteria include: 1) Primary school students within the age range of 7-12 years. 
2) Students and their parents who voluntarily agree to participate in the study and 
provide signed informed consent. 3) Permanent residents of Dongguan City who are 
expected to complete the project without transferring schools during the study period. 
In addition, 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, or unwilling to participate in 
the project, will be excluded.  
 
Sampling method 
The study employs a multi-stage cluster sampling method. In the first stage, one 
central urban area (tentatively identified as Dongcheng Street, which oversees 31 
primary schools) and one non-central urban area (tentatively identified as Gaobu 
Town, which oversees 13 primary schools) will be randomly selected, reflecting the 
urban-rural structure of Dongguan City. In the second stage, ten primary schools will 
be randomly selected from each administrative district, with five designated as 
intervention group schools and the remaining five as control group schools. This 
results in a total of twenty primary schools, evenly split between the intervention and 

5 
 
control groups. In the third stage, two classes from each of the two grades (fourth and 
fifth grades) are randomly selected from each of the twenty selected schools using a 
cluster sampling method, with surveys conducted at the class level. Each school 
comprises a minimum of 152 students. Schools with 152 students will have one 
additional class randomly selected. The final estimated total sample size is projected 
to be 3036. Random sampling and randomized grouping are achieved using computer 
software to generate random numbers. The sample size is determined using the 
following formula: 
𝑛𝑛=
ቄ𝑧𝑧1−𝛼𝛼/2 ඥ2 (𝑚𝑚−1)𝜌𝜌+ 2 + 𝑧𝑧𝛽𝛽ඥ(𝑚𝑚𝑚𝑚+ 1)ቅ
2
∗{𝑝𝑝1(1 −𝑝𝑝1) + 𝑝𝑝2(1 −𝑝𝑝2)}
(𝑝𝑝1 −𝑝𝑝2)2
 
where: 𝑛𝑛 is the desired sample size for each cohort, 𝑧𝑧1−𝛼𝛼/2  is the value 
corresponding to the accepted Type I error rate (eg 𝑧𝑧1−𝛼𝛼/2 about 1.96 for an error rate 
of 0.05 ), 𝑧𝑧𝛽𝛽is the value corresponding to the desired statistical power, e.g., for a 
power of 0.8, 𝑧𝑧𝛽𝛽 is approximately 0.84. 𝑚𝑚 is the size of each cohort, 𝜌𝜌 is the intra-
group correlation coefficient, 𝑝𝑝1 is the expected outcome rate in the test group (ie, 
influenza vaccination rate), and 𝑝𝑝2 is the expected outcome rate in the control group. 
Based on the assumption that the anticipated influenza vaccination rate is 80% in the 
intervention group and 50% in the control group, the estimated sample size, denoted 
as 'n', is 138 students per school.13, 14 This implies that approximately 138 primary 
school students are required for each group, yielding a total sample size of 2760 
individuals. To account for potential sample attrition, the sample size is expanded by 
10%, resulting in a final estimated total sample size of 3036 for statistical analysis.  
 
Intervention methods 
The intervention group will receive a health education intervention focused on 

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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. The details are as follows: 
1) Educational activities include classroom lectures and parent meetings. Medical 
professionals or public health experts will be invited to deliver lectures at the school, 
providing detailed information on the role and benefits of influenza vaccination and 
the risks of influenza. Teachers and relevant school staff will be trained to understand 
the importance of influenza vaccination, reinforcing these messages in everyday 
teaching. Content about influenza vaccines will be incorporated into school health 
education courses, facilitating student learning about influenza vaccines. In addition, 
Teachers will discuss the importance of the flu vaccine at parent meetings, 
encouraging parents to facilitate their children's vaccination. 
2) Promotional materials include educational booklet, animated videos, vaccination 
service and vaccination souvenirs. Educational booklet will be designed and distribute 
to students to raise their awareness of flu vaccines. Animated videos will be created to 
explain the effects of flu vaccines and the benefits of vaccination in an easy-to-
understand manner. These videos will be played on school TVs or computers, and 
students will be organized to watch them. Influenza vaccination services will be 
provided to students who have no contraindications to influenza vaccination, are in 

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good health, and are 4-6 months post their last influenza vaccination, based on the 
principle of informed consent, voluntariness, and self-payment. 'Epidemic Prevention 
Little Guards' medals will be created and distributed to vaccinated students as a 
commemorative incentive to encourage vaccination. 
 
Intervention time 
Staff of the affiliated street Center for Disease Prevention and Control (CDC) will visit 
the school in the first month to implement intervention activities using the health 
education intervention package. The intervention period will commence in September 
2023 and conclude in February 2024, resulting in a total intervention duration of 
approximately three to four months. The specific intervention process is as follows: 1) 
At the start of the semester (early intervention stage in September 2023), initiation 
activities will be conducted. The investigators will introduce the study to teachers and 
students, and medical professionals or public health experts will be invited to deliver 
classroom lectures at the intervention group schools. Baseline data will be collected at 
this stage. 2) During the intervention period (September 2023 – January 2024), the 
intervention group will follow the health education intervention toolkit to conduct 
intervention activities. 3) At the conclusion of the semester (February 2024), follow-up 
data will be collected. The intervention timeline is shown in the Figure 2. 
 
Data collection and analysis 
Questionnaire surveys will be administered to students and parents before and after 

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the intervention, using self-completion. The questionnaire design, which is informed 
by similar research literature (Appendix 1 & 2), will undergo evaluations for 
reliability and validity. The questionnaire will include the following content: 1) Socio-
demographic characteristics (name, age, sex, class, residential address, parents' 
educational level, occupation, family income); 2) Personal history (basic disease 
history, allergy history, and personal history); 3) Influenza vaccination health literacy 
level. The health literacy level concerning influenza vaccination will be assessed 
across four dimensions: knowledge, attitude, behavior, and skills related to influenza 
vaccination. Details of these four dimensions include knowledge of basic facts about 
the influenza vaccine (such as its efficacy, vaccination frequency, and side effects), 
attitudes towards the influenza vaccine (including perceptions of its efficacy and 
safety), behavioral characteristics related to influenza vaccination (such as willingness 
to be vaccinated, vaccination status, and timing of vaccination), and sources of 
information about the influenza vaccine. 
 
Confirmation of influenza and surveillance of influenza-like cases 
Influenza cases are characterized by initial symptoms such as fever, headache, 
myalgia, and general malaise, with body temperatures potentially reaching 39-40°C. 
Patients may experience chills, muscle and joint pain, fatigue, loss of appetite, nasal 
congestion, runny nose, substernal discomfort, facial flushing, and conjunctival 
hyperemia. Confirmed cases must have one or more of the following positive 
pathogenic test results: influenza virus nucleic acid test, influenza antigen test, 
influenza virus culture isolation, and a four-fold or greater increase in the level of 
influenza virus-specific IgG antibody in the convalescent and recovery period double 
sera compared to the acute stage.  

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Confirmed cases of influenza will primarily be identified through the municipal CDC 
influenza surveillance network. Furthermore, influenza-like illness (ILI) is defined as 
instances of fever (body temperature ≥ 38°C) accompanied by either a cough or sore 
throat, with epidemiological evidence or a positive influenza rapid antigen test, and 
excluding other diseases that cause influenza-like symptoms. The fever should occur 
within the current acute febrile illness period. Body temperature identification 
includes self-measurement by patients and temperature detection by medical 
institutions. Identification of ILI cases can be achieved through establishment of a 
case reporting system in schools or student or parent self-report. The case reporting 
system in schools involves training school medical staff and teachers to understand 
the definition and reporting methods for ILI cases. When students exhibit influenza-
like symptoms (such as fever, cough, sore throat, or other symptoms), the school's 
medical staff or teachers will report these cases. Concurrently, a morning inspection 
and registration system for illness-related absenteeism will be implemented. Cases 
identified through the student or parent self-report will be obtained by questionnaires, 
telephone calls, emails, or online platform reports. 
 
Study outcomes 
Primary outcomes include the influenza vaccination rate and the influenza vaccination 
health literacy level. The influenza vaccination rate will be calculated as the number 
of vaccinated individuals divided by the total number of individuals, multiplied by 
100%. Regarding the influenza vaccination health literacy level, each correct answer 
for the scale will be scored as one point, with incorrect answers receiving no points. 
Based on the scores, health literacy levels will be categorized as low, medium, or 

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high. 
 
Secondary outcomes include influenza incidence, the ILI incidence and the influenza 
vaccine protection rate. The influenza incidence will be calculated as the number of 
individuals diagnosed with influenza divided by the total number of individuals, 
multiplied by 100%, The ILI incidence will be calculated as the number of ILI cases 
divided by the total number of participants, multiplied by 100%. 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%. 
 
Statistical analysis plan 
Continuous variables will be described using means ± standard deviation or median 
(interquartile range), and comparisons will be made using two independent samples t-
tests or Wilcoxon rank-sum tests. Categorical variables will be described using 
frequency and composition ratios, and rate comparisons will be conducted using Chi-
square tests or Fisher's exact probability method. The association between the level of 
influenza vaccination health literacy and vaccination willingness will be analyzed 
using multivariate logistic regression. 
 
Quality control  
Quality Control will be conducted in accordance with the requisite quality control 
standards, with dedicated on-site quality control personnel assigned to oversee 
investigation and evaluation. These personnel should be proficient in various testing 
technical requirements and quality control points, and familiar with the on-site 

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organizational process and division of responsibilities. Their primary responsibilities 
include: on-site inspection of various investigation and evaluation operational 
processes, immediate correction of identified issues; on-site review and re-testing of 
collected information, with rectification based on re-test results; collection, 
summarization, and analysis of investigation and evaluation quality control issues, 
with timely reporting and sharing of these issues. 
 
Patient and public involvement 
Students and their parents, teachers, and/or the public were not involved in the design, 
or conduct, or reporting, or dissemination plans of this study. 
 
ETHICS AND DISSEMINATION 
This study follows the Declaration of Helsinki and the Chinese clinical trial research 
ethics and regulations. Before the commencement of the project, ethical approval has 
been sought from the Ethics Committee of the School of Public Health, Sun Yat-sen 
University. The research process respects the autonomy of students and schools. The 
primary schools selected for this study have an equal probability of being assigned to 
either the intervention or control group, ensuring the impartiality and fairness of the 
research. Prior to the initiation of the study, the lead researcher provided an overview 
of the study's purpose, procedures, and potential risks. Comprehensive informed 
consent forms, detailing the study's intent, processes, and potential risks, will be 
handed to both students and their guardians, and participation is strictly voluntary. 
Data confidentiality is ensured through anonymization and restricted access, with only 
the core study team able to view raw data. Provisions are also in place to address any 
adverse reactions or events related to the study or vaccination. 

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Findings from the study will be made accessible to both the scientific community and 
the public. Results are slated for submission to peer-reviewed journals, ensuring 
validation and broader reach within the research community. Beyond academic 
circles, outcomes will be relayed to key stakeholders, including school officials, 
health departments, and community leaders, fostering informed decisions at the 
grassroots level. Additionally, feedback sessions, online postings, and conference 
presentations are avenues being considered to ensure widespread dissemination and 
awareness. 
 
Funding: This work was supported by the Department of Education of Guangdong 
Province (grant number: 51000-42240006). 
 
REFERENCES  
1 C Xu, Liu L, Ren B, et al. Incidence of influenza virus infections confirmed by 
serology in children and adult in a suburb community, northern China, 2018-2019 
influenza season. Influenza Other Respir Viruses. 2021;15(2):262-9. 
2 M Van Ranst, Zöllner Y, Schelling J, et al. The burden of seasonal influenza: 
improving vaccination coverage to mitigate morbidity and its impact on healthcare 
systems. Expert Rev Vaccines. 2023;22(1):518-9. 
3 H Liu, Zhang Y, Tian Y, et al. Epidemic features of seasonal influenza transmission 
among eight different climate zones in Gansu, China. Environ Res. 2020;183:109189. 
4 C Diamond, Gong H, Sun FY, et al. Regional-based within-year seasonal variations 
in influenza-related health outcomes across mainland China: a systematic review and 

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spatio-temporal analysis. BMC Med. 2022;20(1):58. 
5 JJ Treanor. CLINICAL PRACTICE. Influenza Vaccination. N Engl J Med. 
2016;375(13):1261-8. 
6 B Michiels, Govaerts F, Remmen R, et al. A systematic review of the evidence on 
the effectiveness and risks of inactivated influenza vaccines in different target groups. 
Vaccine. 2011;29(49):9159-70. 
7 C Lorini, Santomauro F, Donzellini M, et al. Health literacy and vaccination: A 
systematic review. Hum Vaccin Immunother. 2018;14(2):478-88. 
8 P Zanobini, Lorini C, Caini S, et al. Health Literacy, Socioeconomic Status and 
Vaccination Uptake: A Study on Influenza Vaccination in a Population-Based Sample. 
Int J Environ Res Public Health. 2022;19(11). 
9 LM Siena, Isonne C, Sciurti A, et al. The Association of Health Literacy with 
Intention to Vaccinate and Vaccination Status: A Systematic Review. Vaccines (Basel). 
2022;10(11). 
10 Y Chen, Gu W, He B, et al. Impact of a community-based health education 
intervention on awareness of influenza, pneumonia, and vaccination intention in 
chronic patients. Hum Vaccin Immunother. 2022;18(1):1-8. 
11 A Llupià, García-Basteiro AL, Olivé V, et al. New interventions to increase 
influenza vaccination rates in health care workers. Am J Infect Control. 
2010;38(6):476-81. 
12 L Tao, Lu M, Wang X, et al. The influence of a community intervention on 
influenza vaccination knowledge and behavior among diabetic patients. BMC Public 

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Health. 2019;19(1):1747. 
 
 
 

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Randomly select 20 schools and allocate them into intervention group 
and control group according to 1:1. Randomly select 2 classes from 
grades 4 to 5 in 10 intervention groups and 10 control groups. A total of 
3036 Students will be included.
Identify students based on inclusion and exclusion criteria
Baseline data will be collected (general demographic characteristics, 
epidemiological history, underlying disease history, allergy history, 
personal history, health literacy level of influenza vaccination)
Intervention group (N=1518): 
Received enhanced health 
education package
Control group (N=1518): 
Received no intervention
Data collection after the intervention
Data entry, analysis, writing and publication of results
 
Figure 1 Overview of the study 
 
 

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Figure 2 Intervention timeline 
 
 

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Appendix  
Appendix I Health Literacy Research Questionnaire (Parent Version) 
Appendix II Health Literacy Research Questionnaire (Student Version) 
Appendix III Registration Form of Influenza-like Cases in the School Clinic 
Appendix IV SPIRIT 2013 Checklist  
 

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Appendix I Questionnaire for the Health Literacy Study of Influenza Vaccination 
among Primary School Students in Dongguan City (Parent Version) 
 
Question 
Basic information 
 
 
The street where your child’s school belong is? 
 
Your child’s school? 
 
Your child’s ID type? 
 
Your child’s ID number? 
 
Your phone number? 
 
Are you the child's father, mother or? 
 
Do you currently live with your children? 
 
Your age? 
 
Your spouse's age? 
 
Your highest level of education? 
 
Your spouse’s highest level of education? 
 
Your occupation? 
 
Your spouse’s occupation? 
 
Your home address? 
 
Your household income? 
 
How many children do you currently have? 
 
How is your child's health? 
Knowledge questions 
 
Do you know what the symptoms of flu are? 
 
Do you know when is the flu season in Dongguan?  
 
Do you know how the flu is transmitted? 
 
Do you think the flu is an infectious disease? 
 
Do you know what the flu vaccine is? 
 
Have you heard of the flu vaccine? 
 
Do you know the minimum age for children to receive their first 

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flu vaccination? 
 
Do you think it's appropriate to get the flu vaccine during a flu 
epidemic? 
 
Do you know the contraindications of flu vaccination? 
 
Do you know what the possible side effects of the flu vaccine 
are? 
Attitude Questions 
 
Do you think the flu is just a cold? 
 
Do you think you need to be quarantined at home after getting 
the flu? 
 
Do you think your family and friends are likely to get the flu 
during the pandemic season? 
 
If you or your child gets the flu, there is a high risk of 
transmitting it to others around you? 
 
Do you think that getting the flu can cause serious consequences 
or complications? 
 
If you or a family member gets the flu, it can have a serious 
impact on your or your family's health? 
 
Do you think the flu vaccination is the most effective preventive 
measure against influenza? 
 
Do you think the flu vaccination is effective in reducing the risk 
of spreading the influenza virus? 
 
Do you think the flu vaccination will reduce the risk of your 
family getting the flu? 
 
Do you think the flu vaccination will reduce the symptoms of 
influenza in your family? 
 
Do you think children are a priority and recommended 
population for the flu vaccination? 
 
Do you think the flu vaccine needs to be given every year to 

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prevent the flu? 
 
Do you think getting a flu vaccine is good for you and your 
child's health? 
 
Do you think it is necessary to get a flu vaccine? 
 
Are you confident that the flu vaccine is safe? 
Behavioral questions 
 
Within the last year, have you ever had influenza (or had a 
sudden onset of illness with a high fever ≥38°C accompanied by 
flu-like symptoms such as generalised malaise, myalgia, sore 
throat, etc.)? 
 
If yes, when was the last time you had influenza (or had a sudden 
onset of illness with high fever ≥38°C accompanied by 
influenza-like symptoms such as generalised malaise, myalgia, 
sore throat, etc.)? 
 
Has your child had influenza (or had a sudden onset of illness 
with high fever ≥38°C, accompanied by flu-like symptoms such 
as generalised weakness, myalgia, sore throat, etc.) within the 
last year? 
 
If yes, when was the last time your child had influenza (or had a 
sudden onset of illness with a high fever ≥38°C accompanied by 
influenza-like symptoms such as generalised malaise, myalgia 
and sore throat)? 
 
Have you taken your child for a flu vaccination between 2020 
and 2022? 
 
Have you or your spouse been vaccinated against flu in 2023? 
 
If you have been vaccinated against flu, when did you or your 
spouse get the flu vaccine this year? 
 
Has your child been vaccinated against flu in 2023? 
 
If your child has been vaccinated against flu, when did your 

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child get the flu vaccine this year? 
 
If your child has been vaccinated against flu, why did you decide 
to take your child for a flu vaccination this year? 
 
If your child hasn’t been vaccinated against flu, why did you 
decide not to take your child for a flu vaccination this year? 
 
If your child has not had a flu vaccination this year, are you 
currently willing to take your child to get one? 
 
Would you be willing to take your child for a flu vaccination in 
the future? 
 
Would you like to recommend that others get the flu vaccine? 
Skill Questions 
 
 
Do you know how to schedule your flu vaccine? 
 
Do you take an active interest in information about flu 
vaccinations? 
 
Where do you get information about flu vaccinations? 
 
 
 

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Appendix II Questionnaire for Health Literacy Study of Influenza Vaccination 
among Primary School Students in Dongguan City (Student Version) 
 
Question 
Basic information 
 
 
Your class? 
 
Your gender? 
 
How old are you? 
knowledge questions 
 
Have you heard of the influenza or flu? 
 
Do you know what the symptoms of having the flu are? 
 
Do you think you can spread the flu to other people when you 
get it? 
 
Do you think you can go to class after getting the flu? 
 
Have you heard of the flu vaccine? 
 
Do you know what the flu vaccine does? 
 
Do you know how the flu vaccine works? (For example, it helps 
our body learn how to beat the flu virus) 
Attitude Questions 
 
Do you think getting a flu vaccine is a good thing or a bad thing? 
 
Are you afraid of getting the flu vaccine? Why? 
Behavioral questions 
 
Within the last year, have you had the flu (or had flu-like 
symptoms such as sudden high fever, temperature over 38°C, 
general lack of energy, headache, sore throat, etc.)? 
 
If yes, when was the last time you had influenza (or had a sudden 
onset of illness with high fever ≥38°C accompanied by 
influenza-like symptoms such as generalised malaise, myalgia, 
sore throat, etc.)? 
 
Have you been vaccinated against flu in 2023? 

23 
 
 
If you have been vaccinated, when did you get your flu vaccine 
in 2023? 
 
Would you like your parents to take you for a flu vaccination? 
Skill Questions 
 
 
Where do you get information about flu vaccinations? 
 
Who do you ask if you have questions about the flu vaccine? 
 
 
 

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Appendix III Registration Form of Influenza-like illness Cases in the School Clinic 
 
School:                  
Serial No. 
See a 
doctor 
Date 
Name 
Gender 
Age 
Body 
temperature 
Symptom 
Remark 
Sore throat 
Cough 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: (1) Influenza-like illness refers to patients exhibiting a body temperature of ≥ 38℃, accompanied by either a cough or sore throat. 
(1) Symptom Column: Please mark a '√' under the appropriate item to indicate the presence of a symptom. 
(2) This form should be completed by the school doctors. 
(3) If there is a history of exposure to live poultry or a live poultry market, please provide this information in the 'Remarks' column. 
 
Filler:                

25 
 
Appendix IV SPIRIT 2013 Checklist  
SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents* 
Section/item 
ItemNo Description 
Addressed on 
page number 
Administrative information 
 
Title 
1 
Descriptive title identifying the study design, population, interventions, and, if applicable, trial 
acronym 
2 
Trial registration 
2a 
Trial identifier and registry name. If not yet registered, name of intended registry 
2 
2b 
All items from the World Health Organization Trial Registration Data Set 
N/A 
Protocol version 
3 
Date and version identifier 
N/A 
Funding 
4 
Sources and types of financial, material, and other support 
15 
Roles and 
responsibilities 
5a 
Names, affiliations, and roles of protocol contributors 
15 
5b 
Name and contact information for the trial sponsor 
N/A 

26 
 
 
5c 
Role of study sponsor and funders, if any, in study design; collection, management, 
analysis, and interpretation of data; writing of the report; and the decision to submit the 
report for publication, including whether they will have ultimate authority over any of these 
activities 
N/A 
 
5d 
Composition, roles, and responsibilities of the coordinating centre, steering committee, 
endpoint adjudication committee, data management team, and other individuals or groups 
overseeing the trial, if applicable (see Item 21a for data monitoring committee) 
N/A 
Introduction 
 
 
 
Background and 
rationale 
6a 
Description of research question and justification for undertaking the trial, including 
summary of relevant studies (published and unpublished) examining benefits and harms for 
each intervention 
4-5 
 
6b 
Explanation for choice of comparators 
7 
Objectives 
7 
Specific objectives or hypotheses 
5 
Trial design 
8 
Description of trial design including type of trial (eg, parallel group, crossover, factorial, 
single group), allocation ratio, and framework (eg, superiority, equivalence, noninferiority, 
exploratory) 
6 
Methods: Participants, interventions, and outcomes 
 
Study setting 
9 
Description of study settings (eg, community clinic, academic hospital) and list of countries 
where data will be collected. Reference to where list of study sites can be obtained 
6 

27 
 
Eligibility criteria 
10 
Inclusion and exclusion criteria for participants. If applicable, eligibility criteria for study 
centres and individuals who will perform the interventions (eg, surgeons, psychotherapists) 
7-8 
Interventions 
11a 
Interventions for each group with sufficient detail to allow replication, including how and 
when they will be administered 
8-10 
11b 
Criteria for discontinuing or modifying allocated interventions for a given trial participant (eg, 
drug dose change in response to harms, participant request, or improving/worsening 
disease) 
N/A 
11c 
Strategies to improve adherence to intervention protocols, and any procedures for 
monitoring adherence (eg, drug tablet return, laboratory tests) 
N/A 
11d 
Relevant concomitant care and interventions that are permitted or prohibited during the trial 
N/A 
Outcomes 
12 
Primary, secondary, and other outcomes, including the specific measurement variable (eg, 
systolic blood pressure), analysis metric (eg, change from baseline, final value, time to 
event), method of aggregation (eg, median, proportion), and time point for each outcome. 
Explanation of the clinical relevance of chosen efficacy and harm outcomes is strongly 
recommended 
12-13 
Participant 
timeline 
13 
Time schedule of enrolment, interventions (including any run-ins and washouts), 
assessments, and visits for participants. A schematic diagram is highly recommended (see 
Figure) 
10, Figure2 
Sample size 
14 
Estimated number of participants needed to achieve study objectives and how it was 
determined, including clinical and statistical assumptions supporting any sample size 
calculations 
7-8 
Recruitment 
15 
Strategies for achieving adequate participant enrolment to reach target sample size 
7-8 

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Methods: Assignment of interventions (for controlled trials) 
 
Allocation: 
 
 
 
Sequence 
generation 
16a 
Method of generating the allocation sequence (eg, computer-generated random numbers), 
and list of any factors for stratification. To reduce predictability of a random sequence, 
details of any planned restriction (eg, blocking) should be provided in a separate document 
that is unavailable to those who enrol participants or assign interventions 
7-8 
Allocation 
concealment 
mechanism 
16b 
Mechanism of implementing the allocation sequence (eg, central telephone; sequentially 
numbered, opaque, sealed envelopes), describing any steps to conceal the sequence until 
interventions are assigned 
7-8 
Implementation 16c 
Who will generate the allocation sequence, who will enrol participants, and who will assign 
participants to interventions 
7-8 
Blinding 
(masking) 
17a 
Who will be blinded after assignment to interventions (eg, trial participants, care providers, 
outcome assessors, data analysts), and how 
N/A 
 
17b 
If blinded, circumstances under which unblinding is permissible, and procedure for revealing 
a participant’s allocated intervention during the trial 
N/A 
Methods: Data collection, management, and analysis 
 
Data collection 
methods 
18a 
Plans for assessment and collection of outcome, baseline, and other trial data, including any 
related processes to promote data quality (eg, duplicate measurements, training of 
assessors) and a description of study instruments (eg, questionnaires, laboratory tests) 
along with their reliability and validity, if known. Reference to where data collection forms 
can be found, if not in the protocol 
10-12, Appendix I-II 

29 
 
 
18b 
Plans to promote participant retention and complete follow-up, including list of any outcome 
data to be collected for participants who discontinue or deviate from intervention protocols 
N/A 
Data 
management 
19 
Plans for data entry, coding, security, and storage, including any related processes to 
promote data quality (eg, double data entry; range checks for data values). Reference to 
where details of data management procedures can be found, if not in the protocol 
10-13 
Statistical 
methods 
20a 
Statistical methods for analysing primary and secondary outcomes. Reference to where 
other details of the statistical analysis plan can be found, if not in the protocol 
13 
 
20b 
Methods for any additional analyses (eg, subgroup and adjusted analyses) 
N/A 
 
20c 
Definition of analysis population relating to protocol non-adherence (eg, as randomised 
analysis), and any statistical methods to handle missing data (eg, multiple imputation) 
N/A 
Methods: Monitoring 
 
Data monitoring 
21a 
Composition of data monitoring committee (DMC); summary of its role and reporting 
structure; statement of whether it is independent from the sponsor and competing interests; 
and reference to where further details about its charter can be found, if not in the protocol. 
Alternatively, an explanation of why a DMC is not needed 
13 
 
21b 
Description of any interim analyses and stopping guidelines, including who will have access 
to these interim results and make the final decision to terminate the trial 
N/A 
Harms 
22 
Plans for collecting, assessing, reporting, and managing solicited and spontaneously 
reported adverse events and other unintended effects of trial interventions or trial conduct 
13 
Auditing 
23 
Frequency and procedures for auditing trial conduct, if any, and whether the process will be 
independent from investigators and the sponsor 
N/A 

30 
 
Ethics and dissemination 
 
Research ethics 
approval 
24 
Plans for seeking research ethics committee/institutional review board (REC/IRB) approval 
14-15 
Protocol 
amendments 
25 
Plans for communicating important protocol modifications (eg, changes to eligibility criteria, 
outcomes, analyses) to relevant parties (eg, investigators, REC/IRBs, trial participants, trial 
registries, journals, regulators) 
N/A 
Consent or 
assent 
26a 
Who will obtain informed consent or assent from potential trial participants or authorised 
surrogates, and how (see Item 32) 
14-15 
 
26b 
Additional consent provisions for collection and use of participant data and biological 
specimens in ancillary studies, if applicable 
N/A 
Confidentiality 
27 
How personal information about potential and enrolled participants will be collected, shared, 
and maintained in order to protect confidentiality before, during, and after the trial 
14-15 
Declaration of 
interests 
28 
Financial and other competing interests for principal investigators for the overall trial and 
each study site 
15 
Access to data 
29 
Statement of who will have access to the final trial dataset, and disclosure of contractual 
agreements that limit such access for investigators 
14 
Ancillary and 
post-trial care 
30 
Provisions, if any, for ancillary and post-trial care, and for compensation to those who suffer 
harm from trial participation 
N/A 
Dissemination 
policy 
31a 
Plans for investigators and sponsor to communicate trial results to participants, healthcare 
professionals, the public, and other relevant groups (eg, via publication, reporting in results 
databases, or other data sharing arrangements), including any publication restrictions 
14-15 

31 
 
 
31b 
Authorship eligibility guidelines and any intended use of professional writers 
N/A 
 
31c 
Plans, if any, for granting public access to the full protocol, participant-level dataset, and 
statistical code 
14-15 
Appendices 
 
 
 
Informed consent 
materials 
32 
Model consent form and other related documentation given to participants and authorised 
surrogates 
20-26 
Biological 
specimens 
33 
Plans for collection, laboratory evaluation, and storage of biological specimens for genetic 
or molecular analysis in the current trial and for future use in ancillary studies, if applicable 
N/A 
*It is strongly recommended that this checklist be read in conjunction with the SPIRIT 2013 Explanation & Elaboration for important clarification 
on the items. Amendments to the protocol should be tracked and dated. The SPIRIT checklist is copyrighted by the SPIRIT Group under the 
Creative Commons “Attribution-NonCommercial-NoDerivs 3.0 Unported” license.