Actively Recruiting
A Phase 3, Randomized, Double-Blind, Placebo-Controlled (Older Adults 60 to 79 Years) and Open-Label (Adults 45 to 60 Years) Multicenter Trial to Study Safety and Immune Response of Dengue Tetravalent Vaccine (TDV) in Adults and Older Adults With or Without Other Health Conditions
Led by Takeda · Updated on 2026-04-29
800
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Dengue fever is a viral infection that can affect adults and elderly people, especially in areas where dengue is common. Researchers are studying the Dengue Tetravalent Vaccine (TDV) in adults aged 45 to 60 years and elderly adults aged over 60 to 79 years. The study aims to understand the side effects of TDV and how well it triggers an immune response, including in those with other health conditions like diabetes, high blood pressure, or kidney disease. Participants will receive two injections of TDV or a placebo during the study, with the second dose given three months after the first. Adults aged 45 to 60 years will receive TDV openly, while elderly participants over 60 will be randomly assigned to receive either TDV or a placebo. Injections are given under the skin, and the study is conducted in multiple centers. Throughout the study, participants will visit the clinic five times for monitoring. Researchers will check for local and systemic side effects shortly after each vaccination, assess antibody levels against the dengue virus, and monitor for any serious health events. The study will continue for up to nine months to observe safety and immune responses in all participants.
CONDITIONS
Brief 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.
- Participant has signed informed consent and privacy authorization before any trial procedures.
- Participant can follow trial procedures and is available for the entire follow-up period.
You will not qualify if you...
- Participant has contraindications, warnings, or precautions for TDV vaccination as specified in product information.
- Participant is allergic to any components of TDV or placebo.
- Participant has behavioral, cognitive, or psychiatric conditions that may interfere with trial participation.
- Participant has a history of severe neurological disorders, seizures, or neuro-inflammatory diseases.
- Participant has illnesses that could affect trial results or pose extra risk.
- Participant has altered immune function, including use of immunosuppressive drugs or infections such as HIV, hepatitis B or C.
- Participant has abnormal spleen or thymus function.
- Participant has bleeding disorders or conditions affecting bleeding time.
- Participant has serious chronic or progressive diseases that are not medically stable.
- Participant has previously received any dengue vaccine.
- Participant had a recent active infection or fever above 38.0°C within 3 days before vaccination.
- Participant used antipyretics or pain medications within 24 hours prior to vaccination.
- Participant has history of substance or alcohol abuse in the past 2 years.
- Female participants who are pregnant, breastfeeding, or sexually active without acceptable contraception.
- Participant received certain vaccines recently or plans to receive other vaccines during the trial.
- Participant is involved in other clinical trials or has participated in dengue or flavivirus vaccine trials unless known to have received placebo.
- Participant or close relatives are involved in the trial conduct.
- Participant is an employee with direct involvement in the trial or related trials at the study center.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 months
Participants receive two subcutaneous injections of the dengue tetravalent vaccine (TDV) or placebo on Day 1 and Day 90.
2 visits for vaccination on Day 1 and Day 90; additional visits for monitoring adverse events up to 28 days after each vaccination
Duration - Up to 9 months after first vaccination
Participants are monitored for safety and immune response through Day 270 after the first vaccination.
Multiple visits including assessments on Day 30, Day 120, and Day 270 to measure immune response and monitor adverse events
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
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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