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临床试验/NCT07501793
NCT07501793进行中(未招募)不适用

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

Tam Anh Research Institute1 个研究点 分布在 1 个国家目标入组 800,000 人开始时间: 2026年3月16日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
800,000
试验地点
1
主要终点
Vaccination Coverage - First Dose

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Retrospective

入排标准

年龄范围
4 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Vaccination Coverage - First Dose

时间窗: Day 0 after recruitment

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

Vaccination Coverage - Second Dose

时间窗: Day 0 after recruitment

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

次要结局

  • To assess the coverage of TAK003 vaccine and its distribution across different strata, including sex, age brackets, geographic areas.(Day 0 after recruitment)
  • To assess the coverage of TAK003 vaccine and its distribution across different strata, including comorbidities(Day 0 after recruitment)

研究者

发起方
Tam Anh Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (1)

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