Dengue VaccinesNCT06898775
Passive Safety Surveillance Data of Dengue Vaccine, Qdenga (TAK 003) in Private Vaccination Sites in Buenos Aires, Argentina.
An observational study of Dengue Vaccines, run by Fundación Vacunar at 1 site in Argentina.
Trial summary
The TAK-003 vaccine, Qdenga, developed by Takeda, was approved by ANMAT in April 2023 and has been available in Argentina since November 2023 for individuals from 4 years old and without limit of age. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dengue Vaccines
- How many people
- 112,345 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Nov 2023to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: People vaccinated with dengue vaccine, TAK-003 at private vaccination centers in Buenos Aires, Argentina
Who may be able to join
- All individuals who were vaccinated with Qdenga at Vacunar centers since November 2023 still 1st November 2024, from 4 years of age with no upper limit in accordance with ANMAT approval and for whom safety data is available through the Vacunar centers passive surveillance systems.
Who cannot join
- Reports with insufficient information to characterize the AEFI will be excluded from the analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Analysis of Passive Safety Surveillance Data of Dengue Vaccine, Qdenga (TAK 003) at Private Vaccination Centers, During 2023 and 2024 Dengue Season in Buenos Aires, Argentina
The TAK-003 vaccine, Qdenga, developed by Takeda, was approved by ANMAT in April 2023 and has been available in Argentina since November 2023 for individuals from 4 years old and without limit of age. Clinical trials demonstrate that Qdenga has a favorable safety profile, adequate immunogenicity for all four serotypes, and efficacy in preventing severe dengue in seropositive and seronegative subjects. However, there are currently limited real-world safety studies on TAK-003, particularly for adults over 60 years old.
The aim of this study is to evaluate Adverse Events Supposedly Attributed to Vaccination and Immunization (AEFI) for TAK-003 vaccine in vaccinated people at private vaccination centers in Buenos Aires metropolitan area.
- Conditions
- Dengue Vaccines
- Keywords
- Dengue, vaccine, safety, passive surveillance, AEFI, TAK-003, Argentina
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals vaccinated with Qdenga at Vacunar centers since November 2023- Nov 2024 | Participants from 4 years of age with no upper limit in accordance with ANMAT approval and for whom safety data is available through the Vacunar centers passive surveillance systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEFI
The incidence of adverse events following immunization (AEFI) will be calculated in terms of the number of notifications per 1,000 doses administered.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start1 Nov 2023
- Primary completion15 Dec 2024
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dengue VaccinesStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 112,345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Vacunar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898775
- Sponsor's protocol ID
- Fundación Vacunar
- Status last verified
- Sep 2026
- First submitted
- 21 Mar 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Passive Safety Surveillance Data of Dengue Vaccine, Qdenga (TAK 003) at Private Vaccination Centers, During 2023 and 2024 Dengue Season in Buenos Aires, Argentina
- ClinicalTrials.gov ID
- NCT06898775
- Acronym / sponsor ID
- Fundación Vacunar
- Conditions
- Dengue Vaccines
- Keywords
- Dengue, vaccine, safety, passive surveillance, AEFI, TAK-003, Argentina
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112,345 participants (actual)
- Lead sponsor
- Fundación VacunarUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 27 Mar 2025 (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 TAK-003 vaccine, Qdenga, developed by Takeda, was approved by ANMAT in April 2023 and has been available in Argentina since November 2023 for individuals from 4 years old and without limit of age. Clinical trials demonstrate that Qdenga has a favorable safety profile, adequate immunogenicity for all four serotypes, and efficacy in preventing severe dengue in seropositive and seronegative subjects. However, there are currently limited real-world safety studies on TAK-003, particularly for adults over 60 years old.
The aim of this study is to evaluate Adverse Events Supposedly Attributed to Vaccination and Immunization (AEFI) for TAK-003 vaccine in vaccinated people at private vaccination centers in Buenos Aires metropolitan area.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals vaccinated with Qdenga at Vacunar centers since November 2023- Nov 2024 | – | –Participants from 4 years of age with no upper limit in accordance with ANMAT approval and for whom safety data is available through the Vacunar centers passive surveillance systems |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People vaccinated with dengue vaccine, TAK-003 at private vaccination centers in Buenos Aires, Argentina
Key inclusion criteria (1 listed)
- All individuals who were vaccinated with Qdenga at Vacunar centers since November 2023 still 1st November 2024, from 4 years of age with no upper limit in accordance with ANMAT approval and for whom safety data is available through the Vacunar centers passive surveillance systems.
Key exclusion criteria (1 listed)
- Reports with insufficient information to characterize the AEFI will be excluded from the 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
Incidence of AEFI
Time frame: 42 days
The incidence of adverse events following immunization (AEFI) will be calculated in terms of the number of notifications per 1,000 doses administered.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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 Vaccines, run by Fundación Vacunar at 1 site in Argentina.
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 1 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: finished, as of the sponsor's last update on 10 Sep 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 Argentina. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of AEFI (time frame: 42 days). 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 10 Sep 2026.