NCT07501793

Brief 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. The study will utilize existing data from the VNVC immunization database. No new data collection or direct participant contact will occur.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

April 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 24, 2026

Last Update Submit

April 7, 2026

Conditions

Keywords

TAK-003QDENGADengue VaccineVietnamDemographicsRetrospective StudyVNVC

Outcome Measures

Primary Outcomes (2)

  • Vaccination Coverage - First Dose

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

    Day 0 after recruitment

  • Vaccination Coverage - Second Dose

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

    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.

    Day 0 after recruitment

  • To assess the coverage of TAK003 vaccine and its distribution across different strata, including comorbidities

    Day 0 after recruitment

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vietnam Vaccine Joint Stock Company

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

Location

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2026

First Posted

March 30, 2026

Study Start

March 16, 2026

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

April 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations