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Dengue Fever

A Study on a New Tetravalent Dengue Vaccine (TDV) Formulation in Healthy Adults

Sponsored by Takeda

About this trial

Last updated 2 months ago

Study ID

DEN-322

Status

Active, not recruiting

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18 to 60 Years
All
All

Trial Timing

Started 5 months ago

What is this trial about?

Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. The TDV in current formulation has been approved by health authorities in many countries around the world. The main aim of the study is to confirm that the TDV new formulation induces the similar immune response as approved TDV. Healthy adults who live in an area in which dengue fever does not occur will receive 2 TDV vaccinations 3-months apart with either the new or the current TDV. Blood samples will be taken before and after the vaccinations. These are necessary to check how well the vaccine works to activate the immune system. During the study, participants will visit their study clinic 5 times.

What are the participation requirements?

Yes

Inclusion Criteria

Adult men and women can participate in this study.
Must be between 18 and 60 years old at the time of study start.
Must be healthy at the time of entering the study.
No

Exclusion Criteria

Cannot have lived in an area in which dengue occurs for 3 months and longer or plan to travel to areas in which dengue occurs during the study.
Cannot have had a known infection or vaccination against dengue, yellow fever, Japanese encephalitis or an encephalitis caused by a tick bite.
Cannot have problems related to spleen or thyme (produces immune cells that protect the body against foreign substances).
Cannot have any history of seizures, conditions affecting the brain, spinal cord and/or eye nerves (neurologic or neuro-inflammatory conditions such as Guillain-Barré syndrome).
Cannot have been vaccinated within 28 days before or plan to be vaccinated within 28 days after the TDV vaccination.
Cannot donate blood, organs or tissues for up to 6 weeks after the 2nd TDV vaccination.

Additional entry criteria will be discussed with the study doctor.

Locations

Location

Status

For more information, view the full study details:

NCT07047521