Dengue VaccinesNCT07812142
Retrospective Analysis of the Second Year of Safety Surveillance of the Qdenga® (TAK-003) Vaccine in Private Vaccination Centers, Including a Sub-analysis of Safety in Adults Over 60 Years of Age
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 aged 4 years and older, with no upper age limit. 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
- What is being tested?
- Tak-003
- Type of treatment
- Vaccines
- How many people
- 94,526 participants
- Where
- 1 siteArgentina
- Study dates
- 2 Nov 2024to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- All individuals vaccinated with Qdenga at Vacunar centers between November 2, 2024 and November 1, 2025, aged 4 years and older with no upper age limit, in accordance with ANMAT approval (7), and for whom safety data are available through the passive surveillance systems of Vacunar centers.
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
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 aged 4 years and older, with no upper age limit. Clinical trials demonstrate that Qdenga has a favorable safety and immunogenicity profile in individuals with and without prior dengue infection. However, real-world safety evidence remains limited, particularly in adults over 60 years of age. The aim of this study is to evaluate adverse events following immunization (AEFI) associated with TAK-003 during the second year of implementation and across the combined two-year period at private vaccination centers in the Buenos Aires metropolitan area, with a particular focus on older adults and hypersensitivity reactions.
- Conditions
- Dengue Vaccines
- Being tested
- Tak-003
- Keywords
- Dengue, TAK003, Vacunar, Restrospective analysis, vaccine, safety, passive surveillance, AEFI, Argentina
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tak-003Biological
Q- Denga vaccine in population >4 years without age limit
| Study group | Role | What they receive |
|---|---|---|
| Individual vaccinated with Qdenga at Vacunar centers since November 2024- Nov 2025 | 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 Receives: Biological: Tak-003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
1- Incidence of adverse events following immunization (AEFI) 2- Overall notification of adverse events following immunization (AEFI)
Incidence of adverse events following immunization (AEFI): notification rate per 1,000 doses administered during the period November 2, 2024-November 1, 2025. and overall notification rate over the full two year implementation.
Measured: November 2, 2024 - November 1, 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start2 Nov 2024
- Primary completion1 Nov 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- 94,526 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
- NCT07812142
- Sponsor's protocol ID
- TAK-003 IIR 2nd year
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To present data in congresses or medical lectures
Publications
Cardona V, Ansotegui IJ, Ebisawa M, El-Gamal Y, Fernandez Rivas M, Fineman S, Geller M, Gonzalez-Estrada A, Greenberger PA, Sanchez Borges M, Senna G, Sheikh A, Tanno LK, Thong BY, Turner PJ, Worm M. World allergy organization anaphylaxis guidance 2020. World Allergy Organ J. 2020 Oct 30;13(10):100472. doi: 10.1016/j.waojou.2020.100472. eCollection 2020 Oct.
PubMed 33204386Gold MS, Amarasinghe A, Greenhawt M, Kelso JM, Kochhar S, Yu-Hor Thong B, Top KA, Turner PJ, Worm M, Law B. Anaphylaxis: Revision of the Brighton collaboration case definition. Vaccine. 2023 Apr 6;41(15):2605-2614. doi: 10.1016/j.vaccine.2022.11.027. Epub 2022 Nov 24.
PubMed 36435707Dreskin SC, Halsey NA, Kelso JM, Wood RA, Hummell DS, Edwards KM, Caubet JC, Engler RJ, Gold MS, Ponvert C, Demoly P, Sanchez-Borges M, Muraro A, Li JT, Rottem M, Rosenwasser LJ. International Consensus (ICON): allergic reactions to vaccines. World Allergy Organ J. 2016 Sep 16;9(1):32. doi: 10.1186/s40413-016-0120-5. eCollection 2016.
PubMed 27679682Jeng MJ, Lee NY, Lee IK, Chen YC, Huang WC, Hsu JC, Tai CH, Lan HM. Prognosis and mortality risk in elderly patients with dengue virus infection: Excess fatality and the urgent need for revising current WHO criteria for elderly patients. Travel Med Infect Dis. 2025 May-Jun;65:102855. doi: 10.1016/j.tmaid.2025.102855. Epub 2025 Apr 15.
PubMed 40246185Tricou V, Low JG, Oh HM, Leo YS, Kalimuddin S, Wijaya L, Pang J, Ling LM, Lee TH, Brose M, Hutagalung Y, Rauscher M, Borkowski A, Wallace D. Safety and immunogenicity of a single dose of a tetravalent dengue vaccine with two different serotype-2 potencies in adults in Singapore: A phase 2, double-blind, randomised, controlled trial. Vaccine. 2020 Feb 5;38(6):1513-1519. doi: 10.1016/j.vaccine.2019.11.061. Epub 2019 Dec 13.
PubMed 31843269Tricou V, Yu D, Reynales H, Biswal S, Saez-Llorens X, Sirivichayakul C, Lopez P, Borja-Tabora C, Bravo L, Kosalaraksa P, Vargas LM, Alera MT, Rivera L, Watanaveeradej V, Dietze R, Fernando L, Wickramasinghe VP, Moreira ED Jr, Fernando AD, Gunasekera D, Luz K, Oliveira AL, Tuboi S, Escudero I, Hutagalung Y, Lloyd E, Rauscher M, Zent O, Folschweiller N, LeFevre I, Espinoza F, Wallace D. Long-term efficacy and safety of a tetravalent dengue vaccine (TAK-003): 4.5-year results from a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Glob Health. 2024 Feb;12(2):e257-e270. doi: 10.1016/S2214-109X(23)00522-3.
PubMed 38245116Patel SS, Rauscher M, Kudela M, Pang H. Clinical Safety Experience of TAK-003 for Dengue Fever: A New Tetravalent Live Attenuated Vaccine Candidate. Clin Infect Dis. 2023 Feb 8;76(3):e1350-e1359. doi: 10.1093/cid/ciac418.
PubMed 35639602
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 the Second Year of Safety Surveillance of the Qdenga® (TAK-003) Vaccine in Private Vaccination Centers, Including a Sub-analysis of Safety in Adults Over 60 Years of Age
- ClinicalTrials.gov ID
- NCT07812142
- Acronym / sponsor ID
- TAK-003 IIR 2nd year
- Conditions
- Dengue Vaccines
- Keywords
- Dengue, TAK003, Vacunar, Restrospective analysis, vaccine, safety, passive surveillance, AEFI, Argentina
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 94,526 participants (actual)
- Lead sponsor
- Fundación VacunarUniversity, hospital or other
- Study start
- 2 Nov 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 10 Sep 2026 (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 aged 4 years and older, with no upper age limit. Clinical trials demonstrate that Qdenga has a favorable safety and immunogenicity profile in individuals with and without prior dengue infection. However, real-world safety evidence remains limited, particularly in adults over 60 years of age. The aim of this study is to evaluate adverse events following immunization (AEFI) associated with TAK-003 during the second year of implementation and across the combined two-year period at private vaccination centers in the Buenos Aires metropolitan area, with a particular focus on older adults and hypersensitivity reactions.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individual vaccinated with Qdenga at Vacunar centers since November 2024- Nov 2025 | – | Biological: Tak-003Participants 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
Key inclusion criteria (1 listed)
- All individuals vaccinated with Qdenga at Vacunar centers between November 2, 2024 and November 1, 2025, aged 4 years and older with no upper age limit, in accordance with ANMAT approval (7), and for whom safety data are available through the passive surveillance systems of Vacunar centers.
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tak-003Q- Denga vaccine in population >4 years without age limit | Biological | Individual vaccinated with Qdenga at Vacunar centers since November 2024- Nov 2025 |
Primary outcome
1- Incidence of adverse events following immunization (AEFI) 2- Overall notification of adverse events following immunization (AEFI)
Time frame: November 2, 2024 - November 1, 2025
Incidence of adverse events following immunization (AEFI): notification rate per 1,000 doses administered during the period November 2, 2024-November 1, 2025. and overall notification rate over the full two year implementation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 33204386Cardona V, Ansotegui IJ, Ebisawa M, El-Gamal Y, Fernandez Rivas M, Fineman S, Geller M, Gonzalez-Estrada A, Greenberger PA, Sanchez Borges M, Senna G, Sheikh A, Tanno LK, Thong BY, Turner PJ, Worm M. World allergy organization anaphylaxis guidance 2020. World Allergy Organ J. 2020 Oct 30;13(10):100472. doi: 10.1016/j.waojou.2020.100472. eCollection 2020 Oct.
- Background: PubMed 36435707Gold MS, Amarasinghe A, Greenhawt M, Kelso JM, Kochhar S, Yu-Hor Thong B, Top KA, Turner PJ, Worm M, Law B. Anaphylaxis: Revision of the Brighton collaboration case definition. Vaccine. 2023 Apr 6;41(15):2605-2614. doi: 10.1016/j.vaccine.2022.11.027. Epub 2022 Nov 24.
- Background: PubMed 27679682Dreskin SC, Halsey NA, Kelso JM, Wood RA, Hummell DS, Edwards KM, Caubet JC, Engler RJ, Gold MS, Ponvert C, Demoly P, Sanchez-Borges M, Muraro A, Li JT, Rottem M, Rosenwasser LJ. International Consensus (ICON): allergic reactions to vaccines. World Allergy Organ J. 2016 Sep 16;9(1):32. doi: 10.1186/s40413-016-0120-5. eCollection 2016.
- Background: PubMed 40246185Jeng MJ, Lee NY, Lee IK, Chen YC, Huang WC, Hsu JC, Tai CH, Lan HM. Prognosis and mortality risk in elderly patients with dengue virus infection: Excess fatality and the urgent need for revising current WHO criteria for elderly patients. Travel Med Infect Dis. 2025 May-Jun;65:102855. doi: 10.1016/j.tmaid.2025.102855. Epub 2025 Apr 15.
- Background: PubMed 31843269Tricou V, Low JG, Oh HM, Leo YS, Kalimuddin S, Wijaya L, Pang J, Ling LM, Lee TH, Brose M, Hutagalung Y, Rauscher M, Borkowski A, Wallace D. Safety and immunogenicity of a single dose of a tetravalent dengue vaccine with two different serotype-2 potencies in adults in Singapore: A phase 2, double-blind, randomised, controlled trial. Vaccine. 2020 Feb 5;38(6):1513-1519. doi: 10.1016/j.vaccine.2019.11.061. Epub 2019 Dec 13.
- Background: PubMed 38245116Tricou V, Yu D, Reynales H, Biswal S, Saez-Llorens X, Sirivichayakul C, Lopez P, Borja-Tabora C, Bravo L, Kosalaraksa P, Vargas LM, Alera MT, Rivera L, Watanaveeradej V, Dietze R, Fernando L, Wickramasinghe VP, Moreira ED Jr, Fernando AD, Gunasekera D, Luz K, Oliveira AL, Tuboi S, Escudero I, Hutagalung Y, Lloyd E, Rauscher M, Zent O, Folschweiller N, LeFevre I, Espinoza F, Wallace D. Long-term efficacy and safety of a tetravalent dengue vaccine (TAK-003): 4.5-year results from a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Glob Health. 2024 Feb;12(2):e257-e270. doi: 10.1016/S2214-109X(23)00522-3.
- Background: PubMed 35639602Patel SS, Rauscher M, Kudela M, Pang H. Clinical Safety Experience of TAK-003 for Dengue Fever: A New Tetravalent Live Attenuated Vaccine Candidate. Clin Infect Dis. 2023 Feb 8;76(3):e1350-e1359. doi: 10.1093/cid/ciac418.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. To present data in congresses or medical lectures
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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: under way, not looking for participants, 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?
This study is still under way. Results are not available in the source record yet.
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?
1- Incidence of adverse events following immunization (AEFI) 2- Overall notification of adverse events following immunization (AEFI) (time frame: November 2, 2024 - November 1, 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07812142, which also lists 7 linked publications.
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.