Demographic Characteristics of TAK-003 Dengue Vaccine Recipients in Vietnam (TAK-003)

April 7, 2026 updated by: Tam Anh Research Institute

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

800000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
    • Ho Chi Minh
      • Ho Chi Minh City, Ho Chi Minh, Vietnam, 700000
        • Vietnam Vaccine Joint Stock Company

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccination Coverage - First Dose
Time Frame: Day 0 after recruitment
Percentage of the population that received the first dose of the TAK-003 vaccine
Day 0 after recruitment
Vaccination Coverage - Second Dose
Time Frame: Day 0 after recruitment
Percentage of the population that completed the two-dose TAK-003 series
Day 0 after recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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.
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
  • 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
Day 0 after recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tam Anh Research Institute

Collaborators

Takeda
Vietnam Vaccine Joint Stock Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2026

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TA-0013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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