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 range4 Years – 60 Years
SexALL
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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
✕. 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 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.