Actively Recruiting
A Study of Dengue Tetravalent Vaccine (TDV) in Adults (Age 45 to 60 and >60 to 79 Years)
Led by Takeda · Updated on 2026-04-29
800
Participants Needed
7
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. Researchers have seen that dengue fever now also happens more often in elderly persons. The main aim of this study is to learn more about the side effects of TDV in adult (45 - 60 years) and elderly (60 - 79 years) persons and about TDV's ability to create an immune response in adult and elderly persons. Another aim is to learn about the side effects of TDV in adult and elderly persons in endemic countries who have one or more additional medical conditions (called comorbidities) such as diabetes mellitus, hypertension or a chronic kidney condition. In this study, participants will receive 2 vaccinations with TDV (the second 3 months after the first). During the study, participants will visit their study clinic 5 times.
CONDITIONS
Official Title
A Study of Dengue Tetravalent Vaccine (TDV) in Adults (Age 45 to 60 and >60 to 79 Years)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is aged 45 to 79 years at the time of entry into the trial.
- Participant is male or female.
- Participant is in good health or has one or more stable medical conditions such as diabetes mellitus, hypertension, or chronic kidney disease, with no changes in these conditions or their medications in the last 3 months.
- Participant has signed informed consent and privacy authorization as required.
- Participant can follow trial procedures and is available for the full duration of the study.
You will not qualify if you...
- Participant has contraindications or warnings for TDV vaccination as specified in official guidelines.
- Participant is allergic to any components of TDV or placebo.
- Participant has behavioral, cognitive, or psychiatric conditions that interfere with trial participation.
- Participant has a history of severe neurological disorders, seizures, or neuro-inflammatory diseases.
- Participant has illnesses or histories that could interfere with the trial or increase risk.
- Participant has altered immune function, including use of immunosuppressive drugs, recent immunoglobulin or blood products, immunostimulants, chemotherapy, or infections such as HIV, hepatitis B or C, or genetic immunodeficiency.
- Participant has abnormalities of spleen or thymus function.
- Participant has bleeding disorders or conditions affecting blood clotting.
- Participant has serious chronic or progressive diseases deemed unstable by the investigator.
- Participant has previously received any dengue vaccine.
- Participant has a current infection or fever over 38°C within 3 days before vaccination.
- Participant has used antipyretics or pain medications within 24 hours before vaccination.
- Participant has a history of substance or alcohol abuse within the past 2 years.
- Female participants who are pregnant, breastfeeding, or sexually active without acceptable contraception as defined.
- Participant has received other vaccines within specified timeframes before or after TDV administration.
- Participant is enrolled in other investigational trials or has participated in previous dengue or flavivirus vaccine trials unless confirmed placebo recipient.
- Participant or first-degree relatives are involved in the trial conduct or are employees with direct trial involvement.
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Fundacion Huesped - PPDS
Buenos Aires, Argentina, C1427CEA
Actively Recruiting
2
Associacao Obras Sociais Irma Dulce Hospital Santo Antonio
Salvador, Estado de Bahia, Brazil, 40444-130
Actively Recruiting
3
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
São José do Rio Preto, São Paulo, Brazil, 15090-000
Actively Recruiting
4
Singapore General Hospital (SGH)
Singapore, Singapore, 169608
Actively Recruiting
5
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Actively Recruiting
6
Ramathibodi Hospital
Ratchathewi, Bangkok, Thailand, 10400
Actively Recruiting
7
Hospital for Tropical Diseases
Ratchathewi, Krung Thep Maha Nakhon-Bangkok, Thailand, 10400
Actively Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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