A Study of Dengue Tetravalent Vaccine (TDV) in Adults (Age 45 to 60 and >60 to 79 Years)
ConditionDengue Fever
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age45-79
SponsorTakeda
About this trial
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.
Eligibility criteria
Qualifiers
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 a medical diagnosis of one or more of diabetes mellitus, hypertension, or chronic kidney disease (that is, comorbidities) and are medically stable in the opinion of the investigator at the time of entry into the trial, as determined by medical history and targeted physical examination. Medically stable is defined as no change in diagnoses or chronic medications (dose or class) for medical reasons in the 3 months prior to participating in the trial.
Participant has signed and dated a written informed consent form and any required privacy authorization prior to the initiation of any trial procedure, and after the nature of the trial has been explained according to local regulatory requirements.
Disqualifiers
Participant has contraindication(s), warning(s), and/or precaution(s) applicable to vaccination with TDV as specified in the Investigator's Brochure and/or approved product label (as applicable) in the participating country.
Participant has a known hypersensitivity or allergy to any of the TDV or placebo components (including excipients).
Participant has behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, could interfere with the participant's ability to take part in the trial.
Participant has a history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (example, Guillain-Barré syndrome).
Trial design
Treatments tested in this trial
- TDV
- Placebo
Treatment groups
800 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov