What is TDV studying for dengue fever?

TDV is being studied to understand its safety and ability to create an immune response in adults and elderly people aged 45 to 79 years. Researchers want to learn about side effects and how well the vaccine works in people with or without other health conditions. The study is sponsored by Takeda and focuses on areas where dengue fever is common.

Who may be eligible for this dengue fever clinical trial?

Adults aged 45 to 79 years who are male or female may be eligible. Participants should be in good health or have stable conditions like diabetes, hypertension, or chronic kidney disease. People who have not received a dengue vaccine before can join. Please review eligibility criteria for more details.

Is there any cost to participate in this dengue fever clinical trial?

Study-related care, including the study vaccine and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase 3

Age: 45Years - 79Years

All Genders

Healthy Volunteers

ID06579755

Phase 3 Study to Evaluate Safety and Immune Response of Dengue Tetravalent Vaccine in Adults Aged 45 to 60 and Older Adults 61 to 79 With or Without Medical Conditions in Dengue Areas

Led by Takeda · Updated on 2026-04-29

800

Participants Needed

Research Sites

N/A

Total Duration

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

Age: 45Years - 79Years

All Genders

Healthy Volunteers

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.

Research Team

Takeda Contact

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Phase 3 Study to Evaluate Safety and Immune Response of Dengue Tetravalent Vaccine in Adults Aged 45 to 60 and Older Adults 61 to 79 With or Without Medical Conditions in Dengue Areas

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria