DEN-321

About this trial

Last updated 2 months ago

Study ID

DEN-321

Status

Recruiting

Type

Interventional

Phase

Phase 3

Placebo

Yes

Accepting

45 to 79 Years

All

Trial Timing

Started 2 months ago

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.

Inclusion Criteria

Men and women aged 45-79 years can participate in this study

Must be healthy, or must have been diagnosed with diabetes mellitus, hypertension, and/or chronic kidney disease

Exclusion Criteria

Cannot have any condition affecting the body’s nervous system (called neurologic disorder), history of seizures or swelling or irritation of brain, spinal cord and/or eye nerves (neuro-inflammatory disorder)

Cannot have any condition or receive medicines that may cause a longer bleeding time

Cannot have certain virus infections

Cannot have received anti-cancer chemotherapy or radiation therapy within 6 months before the 1st vaccination with TDV

Cannot have received another vaccination against dengue virus earlier

Cannot have received a vaccination within 1 month before entering the study or plan to receive a vaccination within 1 month after vaccination with TDV.

Additional entry criteria will be discussed with the study doctor.