Evaluate the Prototype Digital Vaccine PlatformNCT06843876
The Evaluation of The Prototype Digital Vaccine Platform "TM-VAX" Among User in The Hospital for Tropical Diseases
A study testing digital vaccine platform "TM VAX" application in people with Evaluate the Prototype Digital Vaccine Platform, run by Mahidol University at 1 site in Thailand.
Trial summary
RATIONALE: Digital technology plays a key role in modern healthcare, impacting diagnosis, treatment, and health information management. Vaccination is a critical tool for disease prevention, reducing healthcare costs, and enhancing quality of life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Evaluate the Prototype Digital Vaccine Platform
- What is being tested?
- digital vaccine platform "TM VAX" application
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2025to 30 Oct 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthcare Provider:
- Aged 18 years or older
- Thai nationality
- Currently working at the Hospital for Tropical Diseases, regardless of work duration
- Have basic skills in using computers, mobile phones, and the internet
- Willing to participate in the study
Show all 11Show fewer
- Patients:
- Aged 18 years or older
- Thai nationality
- Have basic skills in using computers, mobile phones and the internet
- Willing to participate in the study
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
RATIONALE:
Digital technology plays a key role in modern healthcare, impacting diagnosis, treatment, and health information management. Vaccination is a critical tool for disease prevention, reducing healthcare costs, and enhancing quality of life. Managing vaccine records accurately is essential due to varying vaccine schedules and dosage requirements. Traditionally, paper-based vaccine records have faced challenges like loss, illegibility, and incomplete information. Digital solutions offer a more reliable method for managing vaccination data efficiently. A vaccine mobile application is a digital tool designed to improve record immunization by using mobile technology. These apps offer features like reliable vaccine information, immunization record tracking, and reminders for vaccinations. They also facilitate communication between individuals, healthcare providers, and public health systems, aiming to boost vaccine uptake and reduce hesitancy. Examples include ReadyVax offer evidence-based vaccine information to healthcare providers and patients, ImmunizeCA for managing immunization records in Canada, and MomsTalkShots, deliver tailored educational content to increase vaccine uptake among specific populations, like pregnant women. Some apps, like HANDI, assist in public health data management, while application SafeVac and v-safe monitor post-vaccination safety. In Thailand, apps like StatelessVac and RamaCovid have supported immunization efforts and Coronavirus disease 2019 (COVID-19) vaccination. Thus, advancing mobile health technologies are valuable tools for improving healthcare delivery and enhancing immunization practices in the modern era.
Read more
OBJECTIVE: To evaluate the prototype digital vaccine platform "TM-VAX" user by Technology Acceptance Model (TAM)
METHODOLOGY:
This is a single-center, cross-sectional study conducted in the Hospital for Tropical Diseases, Mahidol University, Bangkok, Thailand, between February and May 2025. The study will recruit 200 participants, divided into two groups: 30 healthcare providers and 170 patients. Participants will be allowed to use the TM-VAX application for a one-week trial. Data will be collected through a single online questionnaire (Jotform), with the researcher distributing the questionnaire link via the LINE application (if applicable) or in-person at the end of study (day7). Data collection takes time around 10-15 minutes. The questionnaire consists of three main parts: demographic data, usage experience, and satisfaction. The sections on usage and satisfaction were developed based on previous literature and validated tools such as the mHealth App Usability Questionnaire (MAUQ) and the Usefulness, Satisfaction, and Ease of Use (USE) Questionnaire. The investigators adapted the usage and satisfaction sections from the MAUQ, including 20 questions organized into two parts. Part 1 comprises four categories: Ease of Use (6 items), System Information and Functionality (5 items), Communication (3 items), and Satisfaction (6 items), which addresses overall user satisfaction. Responses are scored on a 5-point Likert scale, with a high score (5 points) indicating very high usage or satisfaction, and the lowest score (1 point) indicating low usage or satisfaction. Part 2 includes open-ended questions to gather users' opinions about a problem and obstacles in using the application, as well as suggestions for improvement. Some participants will be randomly selected to in-depth interview (if participants are willing to do so).
- Being tested
- digital vaccine platform "TM VAX" application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital vaccine platform "TM VAX" applicationOther
Physicians and healthcare providers and Patients will use the TM-VAX system for at least one week. Investigators will distribute the online questionnaire via Jotform through the LINE application at day 7, which will take around 10-15 minutes to complete. If participants have any questions or encounter any issues with the questionnaire, the research team will provide assistance and answer questions via the LINE application or in-person
| Study group | Role | What they receive |
|---|---|---|
| Subgroup: Healthcare Provider and Patients | Experimental | Not described Receives: Other: digital vaccine platform "TM VAX" application |
What is being measured
The primary outcome is the main question the study is designed to answer.
User satisfaction score with the digital vaccine platform "TM-VAX" as measured by the Technology Acceptance Model (TAM) Questionnaire
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 May 2025
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluate the Prototype Digital Vaccine PlatformStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thundon Ngamprasertchai, MD, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843876
- Sponsor's protocol ID
- MUTM 2025-003-01
- Status last verified
- Oct 2026
- First submitted
- 18 Feb 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of The Prototype Digital Vaccine Platform "TM-VAX" Among User in The Hospital for Tropical Diseases
- ClinicalTrials.gov ID
- NCT06843876
- Acronym / sponsor ID
- MUTM 2025-003-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 25 Feb 2025 (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.
RATIONALE:
Digital technology plays a key role in modern healthcare, impacting diagnosis, treatment, and health information management. Vaccination is a critical tool for disease prevention, reducing healthcare costs, and enhancing quality of life. Managing vaccine records accurately is essential due to varying vaccine schedules and dosage requirements. Traditionally, paper-based vaccine records have faced challenges like loss, illegibility, and incomplete information. Digital solutions offer a more reliable method for managing vaccination data efficiently. A vaccine mobile application is a digital tool designed to improve record immunization by using mobile technology. These apps offer features like reliable vaccine information, immunization record tracking, and reminders for vaccinations. They also facilitate communication between individuals, healthcare providers, and public health systems, aiming to boost vaccine uptake and reduce hesitancy. Examples include ReadyVax offer evidence-based vaccine information to healthcare providers and patients, ImmunizeCA for managing immunization records in Canada, and MomsTalkShots, deliver tailored educational content to increase vaccine uptake among specific populations, like pregnant women. Some apps, like HANDI, assist in public health data management, while application SafeVac and v-safe monitor post-vaccination safety. In Thailand, apps like StatelessVac and RamaCovid have supported immunization efforts and Coronavirus disease 2019 (COVID-19) vaccination. Thus, advancing mobile health technologies are valuable tools for improving healthcare delivery and enhancing immunization practices in the modern era.
OBJECTIVE: To evaluate the prototype digital vaccine platform "TM-VAX" user by Technology Acceptance Model (TAM)
METHODOLOGY:
This is a single-center, cross-sectional study conducted in the Hospital for Tropical Diseases, Mahidol University, Bangkok, Thailand, between February and May 2025. The study will recruit 200 participants, divided into two groups: 30 healthcare providers and 170 patients. Participants will be allowed to use the TM-VAX application for a one-week trial. Data will be collected through a single online questionnaire (Jotform), with the researcher distributing the questionnaire link via the LINE application (if applicable) or in-person at the end of study (day7). Data collection takes time around 10-15 minutes. The questionnaire consists of three main parts: demographic data, usage experience, and satisfaction. The sections on usage and satisfaction were developed based on previous literature and validated tools such as the mHealth App Usability Questionnaire (MAUQ) and the Usefulness, Satisfaction, and Ease of Use (USE) Questionnaire. The investigators adapted the usage and satisfaction sections from the MAUQ, including 20 questions organized into two parts. Part 1 comprises four categories: Ease of Use (6 items), System Information and Functionality (5 items), Communication (3 items), and Satisfaction (6 items), which addresses overall user satisfaction. Responses are scored on a 5-point Likert scale, with a high score (5 points) indicating very high usage or satisfaction, and the lowest score (1 point) indicating low usage or satisfaction. Part 2 includes open-ended questions to gather users' opinions about a problem and obstacles in using the application, as well as suggestions for improvement. Some participants will be randomly selected to in-depth interview (if participants are willing to do so).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subgroup: Healthcare Provider and Patients | Experimental | Other: digital vaccine platform "TM VAX" application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 18 years or older
- Thai nationality
- Currently working at the Hospital for Tropical Diseases, regardless of work duration
- Have basic skills in using computers, mobile phones, and the internet
- Willing to participate in the study
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| digital vaccine platform "TM VAX" applicationPhysicians and healthcare providers and Patients will use the TM-VAX system for at least one week. Investigators will distribute the online questionnaire via Jotform through the LINE application at day 7, which will take around 10-15 minutes to complete. If participants have any questions or encounter any issues with the questionnaire, the research team will provide assistance and answer questions via the LINE application or in-person | Other | Subgroup: Healthcare Provider and Patients |
Primary outcome
User satisfaction score with the digital vaccine platform "TM-VAX" as measured by the Technology Acceptance Model (TAM) Questionnaire
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital vaccine platform "TM VAX" application in people with Evaluate the Prototype Digital Vaccine Platform, run by Mahidol University at 1 site in Thailand.
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 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User satisfaction score with the digital vaccine platform "TM-VAX" as measured by the Technology Acceptance Model (TAM) Questionnaire (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.