DengueTAK-003NCT07501793
Demographic Characteristics of TAK-003 Dengue Vaccine Recipients in Vietnam
An observational study of Dengue, run by Tam Anh Research Institute at 1 site in Vietnam.
Trial summary
The study aims to retrospectively describe the demographic characteristics, comorbidity profiles, vaccination history and vaccination patterns of all individuals who have received at least one dose of TAK-003 (Qdenga) dengue vaccine at all VNVC centers between September 26, 2024 and September 30, 2025. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dengue
- How many people
- 800,000 participants
- Where
- 1 siteVietnam
- Study dates
- 16 Mar 2026to 30 Apr 2026
- 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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All individuals who were vaccinated with at least one dose of TAK-003 at all VNVC vaccination centers in Vietnam from 26/09/2024 to 30/09/2025
Who may be able to join
- All individuals who were vaccinated with at least one dose of TAK-003 at all VNVC vaccination centers in Vietnam from 26/09/2024 to 30/09/2025
Who cannot join
- Cases in which TAK-003 vaccination occurred outside the defined study period (from September 26, 2024, to September 30, 2025).
- Records that are duplicates, missing or contain inconsistent information on key demographic or clinical characteristics (age, sex, TAK-003 dose [first or second]) as such data are essential for analysis
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Vietnam Vaccine Joint Stock Company
Ho Chi Minh City, Ho Chi Minh, 700000
About this study
Official title: Demographic Profile of TAK-003 (Qdenga) Dengue Vaccine Recipients During the First Year of the Vaccination Period at VNVC Vaccination Centers in Vietnam
The study aims to retrospectively describe the demographic characteristics, comorbidity profiles, vaccination history and vaccination patterns of all individuals who have received at least one dose of TAK-003 (Qdenga) dengue vaccine at all VNVC centers between September 26, 2024 and September 30, 2025. The study will utilize existing data from the VNVC immunization database. No new data collection or direct participant contact will occur.
Read the detailed description
This is a retrospective, observational, multicenter study using existing vaccination records from the Vietnam Vaccine Joint Stock Company (VNVC) immunization database. The study will analyze data from all individuals who received at least one dose of the TAK-003 (Qdenga) dengue vaccine between September 26, 2024 and September 30, 2025. No new data collection or participant contact will be performed.
The study will be conducted using data collected from all VNVC vaccination centers nationwide. VNVC is the most extensive private vaccination provider in Vietnam, with nearly 250 centers distributed across more than 50 provinces and cities. VNVC customers can be considered broadly representative of the Vietnamese population, reflecting a wide range of demographic, ethnic, and socioeconomic groups and levels.
Data will be obtained from the VNVC centralized immunization database (Web-based), which systematically records all vaccination activities across VNVC centers nationwide. The database includes detailed demographic, clinical, and vaccination-related information collected during each client's visit.
The VNVC data management team will extract relevant data fields for individuals who received at least one dose of TAK-003 during the study period. All data will be deidentified by VNVC before being shared with the research team in Tam Anh Research Institute (TAMRI). Personally identifiable information (e.g., name, phone numbers, address, or ID numbers) will be removed before transfer.
The de-identified dataset will then be securely transferred to TAMRI. TAMRI's data management team will be responsible for data cleaning (identifying missing, inconsistent or duplicate entries), basic data validation and preparing dataset for statistical analysis. The finalized dataset will then be analyzed using standard statistical software.
All analyses will be descriptive in nature, designed to characterize the demographic and clinical profile of individuals who received the TAK-003 vaccine and to estimate vaccination coverage and uptake patterns within the VNVC network. No inferential hypothesis testing will be performed.
- Conditions
- Dengue
- Keywords
- TAK-003, QDENGA, Dengue Vaccine, Vietnam, Demographics, Retrospective Study, VNVC
- Medical subject headings
- Dengue
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccination Coverage - First Dose
Percentage of the population that received the first dose of the TAK-003 vaccine
Measured: Day 0 after recruitment
Vaccination Coverage - Second Dose
Percentage of the population that completed the two-dose TAK-003 series
Measured: Day 0 after recruitment
Secondary outcomes (2)
To assess the coverage of TAK003 vaccine and its distribution across different strata, including sex, age brackets, geographic areas.
Descriptive analysis of primary outcomes, stratified by age group, sex, and geographic region where appropriate:
- Age group Age of individuals at the first dose of the TAK-003 dengue vaccine administered, categorized by age groups.
- Sex Distribution of male and female participants among those who received at least one dose of the TAK-003 vaccine.
- Ethnicity Self-reported ethnic background of the vaccinated individuals.
- Participant Occupation The employment status or professional category of the individuals at the time of vaccination.
- Geographic Distribution - Participant Residence The province-level location of the participant's residence at the time of vaccination.
- Geographic Distribution - Vaccination Site The specific VNVC vaccination center location where the TAK-003 vaccine was administered.
Measured: Day 0 after recruitment
To assess the coverage of TAK003 vaccine and its distribution across different strata, including comorbidities
- Clinical Characteristics: Underlying Medical Conditions Presence or absence of pre-existing medical conditions at the time of vaccination.
- Prevalence of Allergic History by Allergen Type: Number of participants with a history of allergy by allergen category. Categorization of participants based on their reported allergies to medications, food (e.g. seafood), previous vaccines, or other environmental allergens (e.g. weather).
Unit of Measure: Number of participants
Measured: Day 0 after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start16 Mar 2026
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DengueStudies 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 800,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tam Anh Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Vietnam Vaccine Joint Stock Company, Takeda
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501793
- Sponsor's protocol ID
- TA-0013
- Acronym
- TAK-003
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demographic Profile of TAK-003 (Qdenga) Dengue Vaccine Recipients During the First Year of the Vaccination Period at VNVC Vaccination Centers in Vietnam
- ClinicalTrials.gov ID
- NCT07501793
- Acronym / sponsor ID
- TAK-003 / TA-0013
- Conditions
- Dengue
- Keywords
- TAK-003, QDENGA, Dengue Vaccine, Vietnam, Demographics, Retrospective Study, VNVC
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 800,000 participants (estimated)
- Lead sponsor
- Tam Anh Research InstituteUniversity, hospital or other
- Collaborators
- Vietnam Vaccine Joint Stock Company, Takeda
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 30 Mar 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.
The study aims to retrospectively describe the demographic characteristics, comorbidity profiles, vaccination history and vaccination patterns of all individuals who have received at least one dose of TAK-003 (Qdenga) dengue vaccine at all VNVC centers between September 26, 2024 and September 30, 2025. The study will utilize existing data from the VNVC immunization database. No new data collection or direct participant contact will occur.
Detailed description
This is a retrospective, observational, multicenter study using existing vaccination records from the Vietnam Vaccine Joint Stock Company (VNVC) immunization database. The study will analyze data from all individuals who received at least one dose of the TAK-003 (Qdenga) dengue vaccine between September 26, 2024 and September 30, 2025. No new data collection or participant contact will be performed.
The study will be conducted using data collected from all VNVC vaccination centers nationwide. VNVC is the most extensive private vaccination provider in Vietnam, with nearly 250 centers distributed across more than 50 provinces and cities. VNVC customers can be considered broadly representative of the Vietnamese population, reflecting a wide range of demographic, ethnic, and socioeconomic groups and levels.
Data will be obtained from the VNVC centralized immunization database (Web-based), which systematically records all vaccination activities across VNVC centers nationwide. The database includes detailed demographic, clinical, and vaccination-related information collected during each client's visit.
The VNVC data management team will extract relevant data fields for individuals who received at least one dose of TAK-003 during the study period. All data will be deidentified by VNVC before being shared with the research team in Tam Anh Research Institute (TAMRI). Personally identifiable information (e.g., name, phone numbers, address, or ID numbers) will be removed before transfer.
The de-identified dataset will then be securely transferred to TAMRI. TAMRI's data management team will be responsible for data cleaning (identifying missing, inconsistent or duplicate entries), basic data validation and preparing dataset for statistical analysis. The finalized dataset will then be analyzed using standard statistical software.
All analyses will be descriptive in nature, designed to characterize the demographic and clinical profile of individuals who received the TAK-003 vaccine and to estimate vaccination coverage and uptake patterns within the VNVC network. No inferential hypothesis testing will be performed.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All individuals who were vaccinated with at least one dose of TAK-003 at all VNVC vaccination centers in Vietnam from 26/09/2024 to 30/09/2025
Key inclusion criteria (1 listed)
- All individuals who were vaccinated with at least one dose of TAK-003 at all VNVC vaccination centers in Vietnam from 26/09/2024 to 30/09/2025
Key exclusion criteria (2 listed)
- Cases in which TAK-003 vaccination occurred outside the defined study period (from September 26, 2024, to September 30, 2025).
- Records that are duplicates, missing or contain inconsistent information on key demographic or clinical characteristics (age, sex, TAK-003 dose [first or second]) as such data are essential for analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vaccination Coverage - First Dose
Time frame: Day 0 after recruitment
Percentage of the population that received the first dose of the TAK-003 vaccine
Vaccination Coverage - Second Dose
Time frame: Day 0 after recruitment
Percentage of the population that completed the two-dose TAK-003 series
2 secondary outcomes
To assess the coverage of TAK003 vaccine and its distribution across different strata, including sex, age brackets, geographic areas.
Time frame: Day 0 after recruitment
To assess the coverage of TAK003 vaccine and its distribution across different strata, including comorbidities
Time frame: Day 0 after recruitment
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 13 Apr 2026.
- Individual participant dataSharing planned: No
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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, run by Tam Anh Research Institute at 1 site in Vietnam.
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 1 inclusion and 2 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 13 Apr 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 Vietnam. 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?
Vaccination Coverage - First Dose (time frame: Day 0 after recruitment). The study lists 2 primary outcomes in all. 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 13 Apr 2026.