Influenza VaccinesNCT06657573
Vaccine Chatbot for Improving Influenza Vaccination Uptake
A study testing An AI-enabled chatbot tailored for influenza vaccine consultation in people with Influenza Vaccines, run by Fudan University at 1 site in China.
Trial summary
This study aims to assess the impact of a vaccine chatbot on improving influenza vaccination uptake among children aged between 6 and 59 months through a cluster randomized trial. Read more about this study
- Who is it for?
- Ages 6 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza Vaccines
- What is being tested?
- An AI-enabled chatbot tailored for influenza vaccine consultation
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2024to 31 Mar 2025
- 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 6 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents of the child visiting clinics.
- Children aged between 6 and 59 months.
- Children who have not received an influenza vaccine in both the current and previous flu seasons and have not yet made an appointment for an influenza vaccine.
- Children who have no contraindications to receiving an influenza vaccine.
- Provide informed consent and willing to participate throughout the study.
Who cannot join
- Children vaccinated or appointed for influenza vaccination or with any contraindication to influenza vaccine.
- Parents with mental disorders or visual/reading impairments, and unable to cooperate with and undergo the intervention activities.
- Unwilling to participate.
Trial locations and contacts
1 site in 1 country.
Anting Xu, BS contact
China1 site
Hangzhou Center for Disease Control and Prevention
Hangzhou, Zhejiang, 310025
Wenwen Gu, MS, 86-571-88000529, guwenwen@hzcdc.com.cn
Wenwen Gu, MS
About this study
Official title: AI-enabled Vaccine Chatbot for Improving Influenza Vaccination Uptake in Children: a Cluster Randomized Trial
This study aims to assess the impact of a vaccine chatbot on improving influenza vaccination uptake among children aged between 6 and 59 months through a cluster randomized trial. Specifically, the main questions it seeks to answer are whether an AI-enabled vaccine chatbot will increase the uptake of influenza vaccine among children and their family members, and how it will influence parents' literacy and confidence towards influenza vaccine. It will explore the potential role of vaccine chatbot on vaccination services.
A cluster randomization will be used to assign children to the intervention and control groups. Parents of children in the intervention group will be invited to use the influenza vaccine chatbot online through WeChat, the mostly widely used social media platform in mainland China, or any web browsers. They can ask any questions related to the influenza vaccine and receive validated answers from the chatbot immediately. The intervention will last one and a half months, with invitations sent every ten days to reinforce the engagement. The control group will not use the chatbot during the intervention duration. After the intervention, the uptake, literacy, and confidence towards influenza vaccine will be compared between the intervention and control groups to evaluate the impact of vaccine chatbot.
Read the detailed description
This is a cluster randomized trial (CRTs) consisting of two arms to evaluate the effectiveness of an AI-enabled vaccine chatbot on influenza vaccination uptake among children aged between 6 and 59 months. Participants regularly visit primary care clinics when they are invited to participate in this trial, and with clinic-days as clusters, a cluster randomization will be used to assign clinic days to the intervention and control groups.
The sample size is calculated based on the primary outcome - the influenza vaccination uptake among children, and the main analysis method, which involves the comparison of differences in vaccination rates between the intervention and control groups after the intervention. According to the vaccination data of study sites, the uptake of influenza vaccine among children aged 6-59 months is around 20% in the previous flu season. In China, influenza vaccination starts in September, and has been available for two months before this trial. Therefore, we assume that the baseline vaccination rate is 10% without the intervention during this trial, and the chatbot intervention would raise this rate by 6 percentage points to 16% at least. We assume a cluster size of 15 children per day per clinic based on routine visiting data. To have 80% power to detect a difference between the group proportions of 0.06, it requires 35 clusters and 525 participants per arm, assuming an intracluster correlation coefficient of 0.005 and a two-sided test with the 0.05 significance level. Assuming at least 10% loss to follow-up, the sample size is 600 participants per arm and 1,200 in total.
Multi-stage sampling will be utilized. Firstly, three representative regions (an urban district, a suburban district, and a rural county) will be selected to represent different economic development levels in China. In each region, four clinics will be selected based on geographical location, economic development, and patient volume. In each clinic, the 6-8 working days will be chosen to conduct this trial, resulting in 72-96 clinic-days (clusters) in 12 clinics in total. In these selected clinic-days, children and their parents regularly visit primary care clinics. All eligible children presenting in the selected clinic-days will be invited to participate by medical staff, and one of their parents will be included in this trial.
Stratified cluster randomized grouping will be employed. All clinic-days will be randomly allocated into intervention group or control group at a 1:1 ratio, stratified by region and clinic, resulting with 36-48 clinic-days per arm. Approximately 400 participants (200 in intervention group; 200 in control group) are expected to participate in this trial in each region, with a total sample size of 1,200 participants, meeting the sample size requirement.
The intervention group will engage with influenza vaccine chatbot for one and a half months, while the control group will receive the standard of care according to the local context, without additional intervention. On the day of the visit, the intervention group will be invited to use the influenza vaccine chatbot online through WeChat or any web browsers, where they can ask any questions related to the influenza vaccine and get validated answers from the chatbot immediately. Staff will be on site to help them use vaccine chatbot for the intervention group. Then, during the 1.5-month intervention, participants in the intervention group will be informed that the chatbot is available for use at their convenience, with coordinators sending the chatbot link every ten days to remind them to use. Conversely, the control group will not use the chatbot, without additional intervention during the trial, but will gain access after the trial ends.
At the end of the 1.5-month intervention, all participants from both intervention and control groups will be invited to complete a questionary survey. Three months after the intervention begins, influenza vaccination status of children and their parents will be collected from the vaccination registration system of local CDCs.
Difference in outcomes between the intervention and control groups will be assessed using t-tests and/or analysis of variance (ANOVA) for normally distributed continuous variables, and the Chi-square or Fisher's exact test will be used for categorical variables. When continuous variables do not meet normal distribution, the Wilcoxon rank-sum test will be employed. Multivariate regression models will be employed to evaluate the effectiveness of the chatbot intervention on the primary and secondary outcomes, adjusting for potential confounders. Given that participants in the intervention group will have varying frequencies and durations of using the chatbot, a dose-response relationship will be employed to evaluate the intervention effects by intervention intensity.
- Conditions
- Influenza Vaccines
- Being tested
- An AI-enabled chatbot tailored for influenza vaccine consultation
- Keywords
- Influenza vaccine, vaccination, vaccine confidence, AI, Chatbot
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An AI-enabled chatbot tailored for influenza vaccine consultationBehavioural
The AI-enabled influenza vaccine chatbot can be accessed online through WeChat or any web browsers. The foundation of this chatbot is an expansive knowledge database, constructed with information sourced exclusively from healthcare authorities such as China CDCs and Health Departments, and thoroughly verified by public health experts. This database integrates data on the disease's burden, susceptibility, and severity, along with in-depth details about the vaccines, including their importance, efficacy, safety, and recommended demographics and timing for vaccination. It also covers types and costs of vaccines, societal norms such as vaccination guidelines, expert recommendations, and vaccination trends both in China and internationally. It also includes misinformation and fact-checking contents and provides information about vaccination services such as locations and appointment scheduling.
| Study group | Role | What they receive |
|---|---|---|
| Influenza Vaccine Chatbot Intervention group | Experimental | In this arm, participants will receive a vaccine chatbot intervention for one and a half months. The AI-enabled influenza vaccine chatbot can be accessed online through WeChat or any web browsers, where people can ask any questions related to the influenza vaccine and get previously validated answers from the chatbot immediately. The chatbot is available for use at their convenience during the 1.5-month intervention, with invitations sent every ten days to reinforce the engagement. Receives: Behavioral: An AI-enabled chatbot tailored for influenza vaccine consultation |
| Control group | No intervention | The control group will not use the chatbot during the intervention duration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influenza vaccination uptake for children
whether the enrolled children receive an influenza vaccine. It will be measured in the survey at the end of the 1.5-month intervention, and be recorded from the vaccination registration system three months after the intervention begins.
Measured: 1.5 months and three months
Secondary outcomes (5)
Influenza vaccination uptake for children's family members
whether children's family members receive an influenza vaccine. It will be measured in the survey at the end of the 1.5-month intervention, and be recorded from the vaccination registration system three months after the intervention begins.
Measured: 1.5 months and three months
Influenza vaccination-specific consultation
whether parents consult health professionals about vaccinating their children with influenza vaccine during the 1.5-month intervention period, collected in the survey at the end of the 1.5-month intervention.
Measured: 1.5 months
Influenza vaccine literacy
A series of ten questions about influenza vaccine knowledge and misinformation, collected in the survey at the end of the 1.5-month intervention. Total literacy score is calculated based on the number of questions answered correctly by the participants.
Measured: 1.5 months
Influenza vaccine confidence
Vaccine Confidence Index, which evaluates parental perceptions of the vaccine's importance, effectiveness, and safety, collected in the survey at the end of the 1.5-month intervention.
Measured: 1.5 months
Sustained vaccination intention
Whether parents intend to vaccinate their children against influenza in the next flu season, collected in the survey at the end of the 1.5-month intervention.
Measured: 1.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start26 Oct 2024 (estimated)
- Primary completion15 Feb 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Influenza VaccinesStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiyuan Hou, Fudan University
- Investigators
- Zhiyuan Hou, PhD, Principal investigator, School of Public Health，Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657573
- Sponsor's protocol ID
- Fudan Univeristy
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article, after de-identification (text, tables, figures, and appendices), will be shared upon reasonable requests. A written data-sharing request for meta-analysis should be submitted by email with a methodologically sound proposal. Proposals should be directed to zyhou@fudan.edu.cn; to gain access, data requestors will need to sign a data access agreement.
Publications
Xianming C, Wu L, Chunyan Z, et al. Study of coverage of influenza and pneumonia vaccinations in children and influencing factors in two areas, China. Chinese Journal of Epidemiology. 2023;44(11):1731-1737.
Nekrasova E, Stockwell MS, Localio R, Shults J, Wynn C, Shone LP, Berrigan L, Kolff C, Griffith M, Johnson A, Torres A, Opel DJ, Fiks AG. Vaccine hesitancy and influenza beliefs among parents of children requiring a second dose of influenza vaccine in a season: An American Academy of Pediatrics (AAP) Pediatric Research in Office Settings (PROS) study. Hum Vaccin Immunother. 2020 May 3;16(5):1070-1077. doi: 10.1080/21645515.2019.1707006. Epub 2020 Feb 4.
PubMed 32017643Szilagyi PG, Albertin CS, Saville AW, Valderrama R, Breck A, Helmkamp L, Zhou X, Vangala S, Dickinson LM, Tseng CH, Campbell JD, Whittington MD, Roth H, Rand CM, Humiston SG, Hoefer D, Kempe A. Effect of State Immunization Information System Based Reminder/Recall for Influenza Vaccinations: A Randomized Trial of Autodialer, Text, and Mailed Messages. J Pediatr. 2020 Jun;221:123-131.e4. doi: 10.1016/j.jpeds.2020.02.020.
PubMed 32446470Williams SE, Adams LE, Sommer EC. Improving Vaccination for Young Children (IVY): A Stepped-Wedge Cluster Randomized Trial. Acad Pediatr. 2021 Sep-Oct;21(7):1151-1160. doi: 10.1016/j.acap.2021.06.001. Epub 2021 Jun 10.
PubMed 34118498Lerner C, Albertin C, Casillas A, Duru OK, Ong MK, Vangala S, Humiston S, Evans S, Sloyan M, Fox CR, Bogard JE, Friedman S, Szilagyi PG. Patient Portal Reminders for Pediatric Influenza Vaccinations: A Randomized Clinical Trial. Pediatrics. 2021 Aug;148(2):e2020048413. doi: 10.1542/peds.2020-048413.
PubMed 34321338Stockwell MS, Shone LP, Nekrasova E, Wynn C, Torres A, Griffith M, Shults J, Unger R, Ware LA, Kolff C, Harris D, Berrigan L, Montague H, Localio AR, Fiks AG. Text Message Reminders for the Second Dose of Influenza Vaccine for Children: An RCT. Pediatrics. 2022 Sep 1;150(3):e2022056967. doi: 10.1542/peds.2022-056967.
PubMed 35965283Howell-Jones R, Gold N, Bowen S, Bunten A, Tan K, Saei A, Jones S, MacDonald P, Watson R, Bennett KF, Chadborn T. Can uptake of childhood influenza immunisation through schools and GP practices be increased through behaviourally-informed invitation letters and reminders: two pragmatic randomized controlled trials. BMC Public Health. 2023 Jan 20;23(1):143. doi: 10.1186/s12889-022-14439-4.
PubMed 36670376Szilagyi PG, Casillas A, Duru OK, Ong MK, Vangala S, Tseng CH, Albertin C, Humiston SG, Ross MK, Friedman SR, Evans S, Sloyan M, Bogard JE, Fox CR, Lerner C. Evaluation of behavioral economic strategies to raise influenza vaccination rates across a health system: Results from a randomized clinical trial. Prev Med. 2023 May;170:107474. doi: 10.1016/j.ypmed.2023.107474. Epub 2023 Mar 2.
PubMed 36870572Tuckerman J, Harper K, Sullivan TR, Cuthbert AR, Fereday J, Couper J, Smith N, Tai A, Kelly A, Couper R, Friswell M, Flood L, Blyth CC, Danchin M, Marshall HS. Short Message Service Reminder Nudge for Parents and Influenza Vaccination Uptake in Children and Adolescents With Special Risk Medical Conditions: The Flutext-4U Randomized Clinical Trial. JAMA Pediatr. 2023 Apr 1;177(4):337-344. doi: 10.1001/jamapediatrics.2022.6145.
PubMed 36806893Szilagyi PG, Duru OK, Casillas A, Ong MK, Vangala S, Tseng CH, Albertin C, Humiston SG, Clark E, Ross MK, Evans SA, Sloyan M, Fox CR, Lerner C. Text vs Patient Portal Messaging to Improve Influenza Vaccination Coverage: A Health System-Wide Randomized Clinical Trial. JAMA Intern Med. 2024 May 1;184(5):519-527. doi: 10.1001/jamainternmed.2024.0001.
PubMed 38497955
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-enabled Vaccine Chatbot for Improving Influenza Vaccination Uptake in Children: a Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT06657573
- Acronym / sponsor ID
- Fudan Univeristy
- Conditions
- Influenza Vaccines
- Keywords
- Influenza vaccine, vaccination, vaccine confidence, AI, Chatbot
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 26 Oct 2024 (estimated)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 24 Oct 2024 (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.
This study aims to assess the impact of a vaccine chatbot on improving influenza vaccination uptake among children aged between 6 and 59 months through a cluster randomized trial. Specifically, the main questions it seeks to answer are whether an AI-enabled vaccine chatbot will increase the uptake of influenza vaccine among children and their family members, and how it will influence parents' literacy and confidence towards influenza vaccine. It will explore the potential role of vaccine chatbot on vaccination services.
A cluster randomization will be used to assign children to the intervention and control groups. Parents of children in the intervention group will be invited to use the influenza vaccine chatbot online through WeChat, the mostly widely used social media platform in mainland China, or any web browsers. They can ask any questions related to the influenza vaccine and receive validated answers from the chatbot immediately. The intervention will last one and a half months, with invitations sent every ten days to reinforce the engagement. The control group will not use the chatbot during the intervention duration. After the intervention, the uptake, literacy, and confidence towards influenza vaccine will be compared between the intervention and control groups to evaluate the impact of vaccine chatbot.
Detailed description
This is a cluster randomized trial (CRTs) consisting of two arms to evaluate the effectiveness of an AI-enabled vaccine chatbot on influenza vaccination uptake among children aged between 6 and 59 months. Participants regularly visit primary care clinics when they are invited to participate in this trial, and with clinic-days as clusters, a cluster randomization will be used to assign clinic days to the intervention and control groups.
The sample size is calculated based on the primary outcome - the influenza vaccination uptake among children, and the main analysis method, which involves the comparison of differences in vaccination rates between the intervention and control groups after the intervention. According to the vaccination data of study sites, the uptake of influenza vaccine among children aged 6-59 months is around 20% in the previous flu season. In China, influenza vaccination starts in September, and has been available for two months before this trial. Therefore, we assume that the baseline vaccination rate is 10% without the intervention during this trial, and the chatbot intervention would raise this rate by 6 percentage points to 16% at least. We assume a cluster size of 15 children per day per clinic based on routine visiting data. To have 80% power to detect a difference between the group proportions of 0.06, it requires 35 clusters and 525 participants per arm, assuming an intracluster correlation coefficient of 0.005 and a two-sided test with the 0.05 significance level. Assuming at least 10% loss to follow-up, the sample size is 600 participants per arm and 1,200 in total.
Multi-stage sampling will be utilized. Firstly, three representative regions (an urban district, a suburban district, and a rural county) will be selected to represent different economic development levels in China. In each region, four clinics will be selected based on geographical location, economic development, and patient volume. In each clinic, the 6-8 working days will be chosen to conduct this trial, resulting in 72-96 clinic-days (clusters) in 12 clinics in total. In these selected clinic-days, children and their parents regularly visit primary care clinics. All eligible children presenting in the selected clinic-days will be invited to participate by medical staff, and one of their parents will be included in this trial.
Stratified cluster randomized grouping will be employed. All clinic-days will be randomly allocated into intervention group or control group at a 1:1 ratio, stratified by region and clinic, resulting with 36-48 clinic-days per arm. Approximately 400 participants (200 in intervention group; 200 in control group) are expected to participate in this trial in each region, with a total sample size of 1,200 participants, meeting the sample size requirement.
The intervention group will engage with influenza vaccine chatbot for one and a half months, while the control group will receive the standard of care according to the local context, without additional intervention. On the day of the visit, the intervention group will be invited to use the influenza vaccine chatbot online through WeChat or any web browsers, where they can ask any questions related to the influenza vaccine and get validated answers from the chatbot immediately. Staff will be on site to help them use vaccine chatbot for the intervention group. Then, during the 1.5-month intervention, participants in the intervention group will be informed that the chatbot is available for use at their convenience, with coordinators sending the chatbot link every ten days to remind them to use. Conversely, the control group will not use the chatbot, without additional intervention during the trial, but will gain access after the trial ends.
At the end of the 1.5-month intervention, all participants from both intervention and control groups will be invited to complete a questionary survey. Three months after the intervention begins, influenza vaccination status of children and their parents will be collected from the vaccination registration system of local CDCs.
Difference in outcomes between the intervention and control groups will be assessed using t-tests and/or analysis of variance (ANOVA) for normally distributed continuous variables, and the Chi-square or Fisher's exact test will be used for categorical variables. When continuous variables do not meet normal distribution, the Wilcoxon rank-sum test will be employed. Multivariate regression models will be employed to evaluate the effectiveness of the chatbot intervention on the primary and secondary outcomes, adjusting for potential confounders. Given that participants in the intervention group will have varying frequencies and durations of using the chatbot, a dose-response relationship will be employed to evaluate the intervention effects by intervention intensity.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza Vaccine Chatbot Intervention group | Experimental | Behavioral: An AI-enabled chatbot tailored for influenza vaccine consultationIn this arm, participants will receive a vaccine chatbot intervention for one and a half months. The AI-enabled influenza vaccine chatbot can be accessed online through WeChat or any web browsers, where people can ask any questions related to the influenza vaccine and get previously validated answers from the chatbot immediately. The chatbot is available for use at their convenience during the 1.5-month intervention, with invitations sent every ten days to reinforce the engagement. |
| Control group | No intervention | –The control group will not use the chatbot during the intervention duration. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Parents of the child visiting clinics.
- Children aged between 6 and 59 months.
- Children who have not received an influenza vaccine in both the current and previous flu seasons and have not yet made an appointment for an influenza vaccine.
- Children who have no contraindications to receiving an influenza vaccine.
- Provide informed consent and willing to participate throughout the study.
Key exclusion criteria (3 listed)
- Children vaccinated or appointed for influenza vaccination or with any contraindication to influenza vaccine.
- Parents with mental disorders or visual/reading impairments, and unable to cooperate with and undergo the intervention activities.
- Unwilling to participate.
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 |
|---|---|---|
| An AI-enabled chatbot tailored for influenza vaccine consultationThe AI-enabled influenza vaccine chatbot can be accessed online through WeChat or any web browsers. The foundation of this chatbot is an expansive knowledge database, constructed with information sourced exclusively from healthcare authorities such as China CDCs and Health Departments, and thoroughly verified by public health experts. This database integrates data on the disease's burden, susceptibility, and severity, along with in-depth details about the vaccines, including their importance, efficacy, safety, and recommended demographics and timing for vaccination. It also covers types and costs of vaccines, societal norms such as vaccination guidelines, expert recommendations, and vaccination trends both in China and internationally. It also includes misinformation and fact-checking contents and provides information about vaccination services such as locations and appointment scheduling. | Behavioural | Influenza Vaccine Chatbot Intervention group |
Primary outcome
Influenza vaccination uptake for children
Time frame: 1.5 months and three months
whether the enrolled children receive an influenza vaccine. It will be measured in the survey at the end of the 1.5-month intervention, and be recorded from the vaccination registration system three months after the intervention begins.
5 secondary outcomes
Influenza vaccination uptake for children's family members
Time frame: 1.5 months and three months
Influenza vaccination-specific consultation
Time frame: 1.5 months
Influenza vaccine literacy
Time frame: 1.5 months
Influenza vaccine confidence
Time frame: 1.5 months
Sustained vaccination intention
Time frame: 1.5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- BackgroundXianming C, Wu L, Chunyan Z, et al. Study of coverage of influenza and pneumonia vaccinations in children and influencing factors in two areas, China. Chinese Journal of Epidemiology. 2023;44(11):1731-1737.
- Background: PubMed 32017643Nekrasova E, Stockwell MS, Localio R, Shults J, Wynn C, Shone LP, Berrigan L, Kolff C, Griffith M, Johnson A, Torres A, Opel DJ, Fiks AG. Vaccine hesitancy and influenza beliefs among parents of children requiring a second dose of influenza vaccine in a season: An American Academy of Pediatrics (AAP) Pediatric Research in Office Settings (PROS) study. Hum Vaccin Immunother. 2020 May 3;16(5):1070-1077. doi: 10.1080/21645515.2019.1707006. Epub 2020 Feb 4.
- Background: PubMed 32446470Szilagyi PG, Albertin CS, Saville AW, Valderrama R, Breck A, Helmkamp L, Zhou X, Vangala S, Dickinson LM, Tseng CH, Campbell JD, Whittington MD, Roth H, Rand CM, Humiston SG, Hoefer D, Kempe A. Effect of State Immunization Information System Based Reminder/Recall for Influenza Vaccinations: A Randomized Trial of Autodialer, Text, and Mailed Messages. J Pediatr. 2020 Jun;221:123-131.e4. doi: 10.1016/j.jpeds.2020.02.020.
- Background: PubMed 34118498Williams SE, Adams LE, Sommer EC. Improving Vaccination for Young Children (IVY): A Stepped-Wedge Cluster Randomized Trial. Acad Pediatr. 2021 Sep-Oct;21(7):1151-1160. doi: 10.1016/j.acap.2021.06.001. Epub 2021 Jun 10.
- Background: PubMed 34321338Lerner C, Albertin C, Casillas A, Duru OK, Ong MK, Vangala S, Humiston S, Evans S, Sloyan M, Fox CR, Bogard JE, Friedman S, Szilagyi PG. Patient Portal Reminders for Pediatric Influenza Vaccinations: A Randomized Clinical Trial. Pediatrics. 2021 Aug;148(2):e2020048413. doi: 10.1542/peds.2020-048413.
- Background: PubMed 35965283Stockwell MS, Shone LP, Nekrasova E, Wynn C, Torres A, Griffith M, Shults J, Unger R, Ware LA, Kolff C, Harris D, Berrigan L, Montague H, Localio AR, Fiks AG. Text Message Reminders for the Second Dose of Influenza Vaccine for Children: An RCT. Pediatrics. 2022 Sep 1;150(3):e2022056967. doi: 10.1542/peds.2022-056967.
- Background: PubMed 36670376Howell-Jones R, Gold N, Bowen S, Bunten A, Tan K, Saei A, Jones S, MacDonald P, Watson R, Bennett KF, Chadborn T. Can uptake of childhood influenza immunisation through schools and GP practices be increased through behaviourally-informed invitation letters and reminders: two pragmatic randomized controlled trials. BMC Public Health. 2023 Jan 20;23(1):143. doi: 10.1186/s12889-022-14439-4.
- Background: PubMed 36870572Szilagyi PG, Casillas A, Duru OK, Ong MK, Vangala S, Tseng CH, Albertin C, Humiston SG, Ross MK, Friedman SR, Evans S, Sloyan M, Bogard JE, Fox CR, Lerner C. Evaluation of behavioral economic strategies to raise influenza vaccination rates across a health system: Results from a randomized clinical trial. Prev Med. 2023 May;170:107474. doi: 10.1016/j.ypmed.2023.107474. Epub 2023 Mar 2.
- Background: PubMed 36806893Tuckerman J, Harper K, Sullivan TR, Cuthbert AR, Fereday J, Couper J, Smith N, Tai A, Kelly A, Couper R, Friswell M, Flood L, Blyth CC, Danchin M, Marshall HS. Short Message Service Reminder Nudge for Parents and Influenza Vaccination Uptake in Children and Adolescents With Special Risk Medical Conditions: The Flutext-4U Randomized Clinical Trial. JAMA Pediatr. 2023 Apr 1;177(4):337-344. doi: 10.1001/jamapediatrics.2022.6145.
- Background: PubMed 38497955Szilagyi PG, Duru OK, Casillas A, Ong MK, Vangala S, Tseng CH, Albertin C, Humiston SG, Clark E, Ross MK, Evans SA, Sloyan M, Fox CR, Lerner C. Text vs Patient Portal Messaging to Improve Influenza Vaccination Coverage: A Health System-Wide Randomized Clinical Trial. JAMA Intern Med. 2024 May 1;184(5):519-527. doi: 10.1001/jamainternmed.2024.0001.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article, after de-identification (text, tables, figures, and appendices), will be shared upon reasonable requests. A written data-sharing request for meta-analysis should be submitted by email with a methodologically sound proposal. Proposals should be directed to zyhou@fudan.edu.cn; to gain access, data requestors will need to sign a data access agreement.
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Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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.
Anting Xu, BS contact
Zhiyuan Hou, PhD principal investigator
School of Public Health，Fudan 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 An AI-enabled chatbot tailored for influenza vaccine consultation in people with Influenza Vaccines, run by Fudan 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 5 inclusion and 3 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 24 Oct 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 Zhiyuan Hou, PhD (86-21-33563935, zyhou@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influenza vaccination uptake for children (time frame: 1.5 months and three months). 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 NCT06657573, which also lists 10 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 24 Oct 2024.