Dengue FeverNCT07759596
Bridging Economics and Public Trust: A Study of Dengue Vaccine Cost-effectiveness and Acceptance in Thais Visiting Hospital
An observational study of Dengue Fever, run by Mahidol University at 1 site in Thailand.
Trial summary
Study 1: Cost-effectiveness of TAK-003 Dengue Vaccination in Thailand This study aims to evaluate the cost-effectiveness of introducing the live-attenuated tetravalent dengue vaccine (TAK-003) into Thailand's national immunization program. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dengue Fever
- What is being tested?
- Objective 1- economic evaluation of Thai children with dengue vaccine
- Type of treatment
- Vaccines
- How many people
- 350 participants
- Where
- 1 siteThailand
- Study dates
- 2 Feb 2026to 1 Dec 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: General population Inclusion criteria - Visiting hospitals for routine follow up their medical conditions at Med OPD, Hospital for Tropical Diseases Mahidol University. Parents Inclusion criteria - Visiting hospitals for their children's routine follow up appointment at children OPD Siriraj Hospital, Mahidol University
Who may be able to join
- Both males and females Thai
- Adults aged 18 years and older
- Willing to participate in the study
- Never received dengue vaccine
- either single or married status without legitimate children
- having independent sources of incomes.
Show all 11Show fewer
- Both males and females Thai
- Adults aged 18 years and older
- Willing to participate in the study
- Having legitimate children aged 4 to 18 years old with dengue vaccine naïve
- Having independent sources of income.
Who cannot join
- All types of Health care personnel
- visiting hospital due to clinical suspicions or confirmation of dengue infection
- Have no prior knowledge or awareness of dengue or dengue vaccines.
- Parents
- All types of Health care personnel
- Visiting hospital due to their children's illnesses such as clinical suspicions or confirmation of dengue infection.
- Have no prior knowledge or awareness of dengue or dengue vaccines.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Hospital for Tropical Diseases, Faculty of Tropical Medicine
Bangkok
About this study
Study 1: Cost-effectiveness of TAK-003 Dengue Vaccination in Thailand
This study aims to evaluate the cost-effectiveness of introducing the live-attenuated tetravalent dengue vaccine (TAK-003) into Thailand's national immunization program. The study will compare routine vaccination strategies targeting two high-risk age groups: older children aged 9-14 years and adolescents/young adults aged 15-24 years, to identify the most appropriate target population for national implementation.
Read more
A model-based economic evaluation will be conducted using a static Markov model combined with a decision tree from a societal perspective. Model parameters will be obtained from published literature, national surveillance databases, healthcare utilization data, and other relevant sources. The model will estimate lifetime health outcomes, healthcare costs, quality-adjusted life years (QALYs), incremental cost-effectiveness ratios (ICERs), and budget impact. Deterministic and probabilistic sensitivity analyses will be performed to assess uncertainty in model parameters.
The findings are expected to provide evidence to support policy decisions regarding the inclusion of TAK-003 in Thailand's national immunization program.
Study 2: Determinants of Dengue Vaccine Acceptance among Thai Adults and Parents
This study aims to examine dengue vaccine acceptance and factors influencing vaccination decisions among Thai adults and parents of children aged 4-18 years. Understanding vaccine acceptance is essential for successful implementation of future dengue vaccination programs in Thailand.
This study will employ a sequential explanatory mixed-methods design consisting of two phases. The first phase is a cross-sectional survey conducted among Thai adults and parents attending outpatient clinics at two tertiary hospitals. Participants will complete a structured questionnaire assessing sociodemographic characteristics, dengue-related experiences, psychological antecedents of vaccination using a modified Thai version of the 7Cs model, willingness to pay, and dengue vaccine acceptance.
In the second phase, purposively selected participants from the quantitative survey will participate in semi-structured in-depth interviews to explore perceptions, beliefs, attitudes, and contextual factors influencing dengue vaccine decision-making. Quantitative and qualitative findings will be integrated to provide a comprehensive understanding of vaccine acceptance and hesitancy.
The findings will provide evidence to inform communication strategies, public health interventions, and policy development aimed at improving dengue vaccine uptake in Thailand.
- Conditions
- Dengue Fever
- Being tested
- Objective 1- economic evaluation of Thai children with dengue vaccine
- Keywords
- economic burden, vaccine acceptance, dengue vaccine, cost-effectiveness
- Medical subject headings
- Dengue, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Objective 1- economic evaluation of Thai children with dengue vaccineOther
Thai children age 9-14 and 15-24 years with dengue vaccine
| Study group | Role | What they receive |
|---|---|---|
| Objective 1- economic evaluation of Thai children without dengue vaccine | Children age 9-14 and 15-24 years without dengue vaccine Receives: Other: Objective 1- economic evaluation of Thai children with dengue vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dengue vaccine hesitancy measured using the 7C-model
Dengue vaccine hesitancy will be assessed using an adapted version of the validated 7C Model of Vaccine Readiness questionnaire. The questionnaire will be adapted to the context of dengue vaccination while retaining the seven psychological antecedents of vaccination: Confidence, Complacency, Constraints, Calculation, Collective Responsibility, Compliance, and Conspiracy.
Scoring of the 7C model: Each item was rated on a 7-point Likert scale from 1 to 7. For each 7C domain, the mean score of its constituent items was calculated, resulting in a domain score ranging from 1 to 7. A higher score indicated greater vaccine hesitancy. Items were reverse-scored where necessary so that the direction of all domain scores was consistent, with higher scores representing greater vaccine hesitancy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start2 Feb 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dengue FeverStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Siriraj Hospital
- Responsible party
- Principal investigator, Thundon Ngamprasertchai, MD, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759596
- Sponsor's protocol ID
- MU-MOU TMEC 25-918
- Status last verified
- Aug 2026
- First submitted
- 23 Feb 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging Economics and Public Trust: A Study of Dengue Vaccine Cost-effectiveness and Acceptance in Thais Visiting Hospital
- ClinicalTrials.gov ID
- NCT07759596
- Acronym / sponsor ID
- MU-MOU TMEC 25-918
- Conditions
- Dengue Fever
- Keywords
- economic burden, vaccine acceptance, dengue vaccine, cost-effectiveness
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Siriraj Hospital
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 Aug 2026 (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.
Study 1: Cost-effectiveness of TAK-003 Dengue Vaccination in Thailand
This study aims to evaluate the cost-effectiveness of introducing the live-attenuated tetravalent dengue vaccine (TAK-003) into Thailand's national immunization program. The study will compare routine vaccination strategies targeting two high-risk age groups: older children aged 9-14 years and adolescents/young adults aged 15-24 years, to identify the most appropriate target population for national implementation.
A model-based economic evaluation will be conducted using a static Markov model combined with a decision tree from a societal perspective. Model parameters will be obtained from published literature, national surveillance databases, healthcare utilization data, and other relevant sources. The model will estimate lifetime health outcomes, healthcare costs, quality-adjusted life years (QALYs), incremental cost-effectiveness ratios (ICERs), and budget impact. Deterministic and probabilistic sensitivity analyses will be performed to assess uncertainty in model parameters.
The findings are expected to provide evidence to support policy decisions regarding the inclusion of TAK-003 in Thailand's national immunization program.
Study 2: Determinants of Dengue Vaccine Acceptance among Thai Adults and Parents
This study aims to examine dengue vaccine acceptance and factors influencing vaccination decisions among Thai adults and parents of children aged 4-18 years. Understanding vaccine acceptance is essential for successful implementation of future dengue vaccination programs in Thailand.
This study will employ a sequential explanatory mixed-methods design consisting of two phases. The first phase is a cross-sectional survey conducted among Thai adults and parents attending outpatient clinics at two tertiary hospitals. Participants will complete a structured questionnaire assessing sociodemographic characteristics, dengue-related experiences, psychological antecedents of vaccination using a modified Thai version of the 7Cs model, willingness to pay, and dengue vaccine acceptance.
In the second phase, purposively selected participants from the quantitative survey will participate in semi-structured in-depth interviews to explore perceptions, beliefs, attitudes, and contextual factors influencing dengue vaccine decision-making. Quantitative and qualitative findings will be integrated to provide a comprehensive understanding of vaccine acceptance and hesitancy.
The findings will provide evidence to inform communication strategies, public health interventions, and policy development aimed at improving dengue vaccine uptake in Thailand.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Objective 1- economic evaluation of Thai children without dengue vaccine | – | Other: Objective 1- economic evaluation of Thai children with dengue vaccineChildren age 9-14 and 15-24 years without dengue vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General population Inclusion criteria - Visiting hospitals for routine follow up their medical conditions at Med OPD, Hospital for Tropical Diseases Mahidol University. Parents Inclusion criteria - Visiting hospitals for their children's routine follow up appointment at children OPD Siriraj Hospital, Mahidol University
Key inclusion criteria (11 listed)
- Both males and females Thai
- Adults aged 18 years and older
- Willing to participate in the study
- Never received dengue vaccine
- either single or married status without legitimate children
Key exclusion criteria (7 listed)
- All types of Health care personnel
- visiting hospital due to clinical suspicions or confirmation of dengue infection
- Have no prior knowledge or awareness of dengue or dengue vaccines.
- Parents
- All types of Health care personnel
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 |
|---|---|---|
| Objective 1- economic evaluation of Thai children with dengue vaccineThai children age 9-14 and 15-24 years with dengue vaccine | Other | Objective 1- economic evaluation of Thai children without dengue vaccine |
Primary outcome
Dengue vaccine hesitancy measured using the 7C-model
Time frame: 1 year
Dengue vaccine hesitancy will be assessed using an adapted version of the validated 7C Model of Vaccine Readiness questionnaire. The questionnaire will be adapted to the context of dengue vaccination while retaining the seven psychological antecedents of vaccination: Confidence, Complacency, Constraints, Calculation, Collective Responsibility, Compliance, and Conspiracy. Scoring of the 7C model: Each item was rated on a 7-point Likert scale from 1 to 7. For each 7C domain, the mean score of its constituent items was calculated, resulting in a domain score ranging from 1 to 7. A higher score indicated greater vaccine hesitancy. Items were reverse-scored where necessary so that the direction of all domain scores was consistent, with higher scores representing greater vaccine hesitancy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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?
An observational study of Dengue Fever, 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 7 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: under way, not looking for participants, as of the sponsor's last update on 17 Aug 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?
This study is still under way. Results are not available in the source record yet.
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?
Dengue vaccine hesitancy measured using the 7C-model (time frame: 1 year). 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 17 Aug 2026.