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NCT Number: NCT07501793

Demographic Characteristics of TAK-003 Dengue Vaccine Recipients 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Dengue Arbovirus Infections Flaviviridae Infections Flavivirus Infections Hemorrhagic Fevers, Viral Infections Mosquito-Borne Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

4 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vietnam Vaccine Joint Stock Company

Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Vaccination Coverage - First Dose

    Time frame: Day 0 after recruitment

    Percentage of the population that received the first dose of the TAK-003 vaccine

  2. Vaccination Coverage - Second Dose

    Time frame: Day 0 after recruitment

    Percentage of the population that completed the two-dose TAK-003 series

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Tam Anh Research Institute

Other

Collaborators

  • Takeda
  • Vietnam Vaccine Joint Stock Company

Registry information

Official study title

Demographic Profile of TAK-003 (Qdenga) Dengue Vaccine Recipients During the First Year of the Vaccination Period at VNVC Vaccination Centers in Vietnam

Acronym: TAK-003

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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