A Study of Dengue Tetravalent Vaccine (TDV) in Healthy Participants in Japan (NCT06741683) | Clinical Trial Compass
CompletedPhase 2/3
A Study of Dengue Tetravalent Vaccine (TDV) in Healthy Participants in Japan
Japan187 participantsStarted 2025-01-31
Plain-language summary
Dengue fever is caused by an infection with the dengue virus. Vaccination with TDV can help prevent dengue fever.
The main purpose of this study is to learn about TDV's ability to create an immune response in adults, adolescents, and children administered. 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.
Participants will be in this study for approximately 270 days (9 months).
Who can participate
Age range
4 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participant aged \>=4 to less than or equal to (\<=) 60 years at the time of signing the informed consent/pediatric assent form.
. Participant is Japanese male or female.
. Participant is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator.
. Participant and/or the participant's legally acceptable representative (LAR) who have signed and dated a written, informed consent/pediatric assent form, and any required privacy authorization prior to the initiation of any trial procedures, and after the nature of the trial has been explained.
. Participant can comply with trial procedures and is available for the duration of follow-up.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Seropositive Participants for Each of the 4 Dengue Virus Serotypes on Day 120
. Participant has contraindication(s), warning(s), and/or precaution(s) applicable to vaccination with TDV as specified in the Investigator's Brochure.
. Participant has a known hypersensitivity or allergy to any of the IMP components (including excipients of the IMP).
. Participant has behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the trial.
. Participant has a history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (example, Guillain-Barré syndrome).
. Participant has a clinically significant active infection (as assessed by the investigator) or body temperature greater than (\>) 38.0 degrees Celsius (°C) (\>100.4 degrees Fahrenheit \[°F\]) within 3 days of intended IMP administration on Day 1 (Month \[M\] 0).
. Participant has an illness, or history of any illness that, in the opinion of the investigator, might interfere with the results of the trial or pose additional risk to the participant due to involvement in this trial.
. Participant has a known or suspected impairment/alteration of immune function, including:
. Chronic administration of oral and/or parenteral steroids at doses considered sufficiently immunosuppressive (example, \>=2 milligram per kilogram \[mg/kg\] body weight prednisone \[or equivalent\] for \>=14 consecutive days, or \>=20 milligram per day \[mg/day\] prednisone \[or equivalent\] administered for \>=14 consecutive days) within 60 days prior to Day 1 (M0), Note: use of corticosteroids by inhaled, intranasal, intra-articular, bursal, tendon injection, or topical routes is allowed.