A Study of Dengue Tetravalent Vaccine (TDV) in Healthy Participants in Japan

Last updated: February 6, 2025
Sponsor: Takeda
Overall Status: Active - Recruiting

Phase

2/3

Condition

N/A

Treatment

Placebo

TDV

Clinical Study ID

NCT06741683
DEN-324
2024-000341-27
jRCT2071240088
  • Ages 4-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant aged >=4 to less than or equal to (<=) 60 years at the time of signingthe informed consent/pediatric assent form.

  2. Participant is Japanese male or female.

  3. Participant is in good health at the time of entry into the trial as determined bymedical history, physical examination (including vital signs) and clinical judgmentof the investigator.

  4. Participant and/or the participant's legally acceptable representative (LAR) whohave signed and dated a written, informed consent/pediatric assent form, and anyrequired privacy authorization prior to the initiation of any trial procedures, andafter the nature of the trial has been explained.

  5. Participant can comply with trial procedures and is available for the duration offollow-up.

Exclusion

Exclusion Criteria:

  1. Participant has contraindication(s), warning(s), and/or precaution(s) applicable tovaccination with TDV as specified in the Investigator's Brochure.

  2. Participant has a known hypersensitivity or allergy to any of the IMP components (including excipients of the IMP).

  3. Participant has behavioral or cognitive impairment or psychiatric disease that, inthe opinion of the investigator, may interfere with the participant's ability toparticipate in the trial.

  4. Participant has a history of progressive or severe neurologic disorder, seizuredisorder or neuro-inflammatory disease (example, Guillain-Barré syndrome).

  5. Participant has a clinically significant active infection (as assessed by theinvestigator) or body temperature greater than (>) 38.0 degrees Celsius (°C) (>100.4degrees Fahrenheit [°F]) within 3 days of intended IMP administration on Day 1 (Month [M] 0). Note: In principle, oral temperature should be measured for body temperature. Incases where it is difficult to measure oral temperature, such as in young children,underarm (axillary) temperature may be used instead.

  6. Participant has an illness, or history of any illness that, in the opinion of theinvestigator, might interfere with the results of the trial or pose additional riskto the participant due to involvement in this trial.

  7. Participant has a known or suspected impairment/alteration of immune function,including:

  8. Chronic administration of oral and/or parenteral steroids at doses consideredsufficiently immunosuppressive (example, >=2 milligram per kilogram [mg/kg]body weight prednisone [or equivalent] for >=14 consecutive days, or >=20milligram per day [mg/day] prednisone [or equivalent] administered for >=14consecutive days) within 60 days prior to Day 1 (M0), Note: use ofcorticosteroids by inhaled, intranasal, intra-articular, bursal, tendoninjection, or topical routes is allowed.

  9. Receipt of blood, immunoglobulins, blood products, and/or plasma derivativeswithin the 90 days prior to Day 1 (M0).

  10. Receipt of immunostimulants within 60 days prior to Day 1 (M0).

  11. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapywithin 6 months prior to Day 1 (M0).

  12. Reported or known symptomatic HIV infection or asymptomatic HIV infection whenaccompanied by evidence of impaired immune function.

  13. Reported or known Hepatitis B and/or Hepatitis C virus infection.

  14. Genetic immunodeficiency.

  15. Participant has known or suspected abnormalities of splenic or thymic function.

  16. Participant has a known bleeding diathesis, or any condition that may be associatedwith a prolonged bleeding time.

  17. Participant has a serious chronic or progressive disease deemed to be preclusive totrial entry, that is not medically stable according to the judgment of theinvestigator.

  18. Participant is participating in any clinical trial with another investigationalproduct within 30 days prior to Day 1 (M0) or plans to participate in anotherclinical trial at any time during the conduct of this trial.

  19. Participant has previously received a vaccination against flavivirus other thanJapanese encephalitis (JE) (investigational or licensed).

  20. Participant who received any other vaccines within 14 days (for inactivatedvaccines) or 28 days (for live vaccines) prior to Day 1 (M0) or who are planning toreceive any vaccine other than IMP within 28 days of IMP administration.

  21. Participant who received a coronavirus vaccine within 14 days prior to Day 1 (M0).

  22. Participant who received a vaccine authorized for emergency use within 28 days priorto Day 1 (M0).

  23. Participant who received any JE vaccines within 28 days prior to Day 1 (M0) or whoare planning to receive any JE vaccines during the trial period.

  24. Previous participation in any clinical trial of a dengue or other flaviviruscandidate vaccine, except for participants who received placebo in those trials.

  25. Participant with body mass index (BMI) >=35 kilograms per square meter (kg/m^2) onDay 1 (M0).

  26. Participant who intends to travel to dengue endemic areas during the trial period.

  27. Participant with documented or suspected disease caused by a flavivirus andparticipants with a history of prolonged (>=1 year) habitation in a dengue endemicarea.

  28. Participant with history of substance or alcohol abuse within the past 2 years priorto Day 1 (M0).

  29. Female participants who are pregnant (that is, a positive or indeterminate pregnancytest) or breastfeeding.

  30. Females of childbearing potential who are sexually active and who have not used anyof the acceptable contraceptive methods for at least 2 months prior to Day 1 (M0).

  31. "Childbearing potential" is defined as status post onset of menarche and notmeeting any of the following conditions: menopausal for at least 2 years,status after bilateral tubal ligation for at least 1 year, status afterbilateral oophorectomy, or status after hysterectomy.

  32. Acceptable contraceptive methods" are defined as one or more of the following:

  • Hormonal contraceptive.
  • Barrier method (condom or diaphragm) every time during intercourse.
  • Intrauterine device.
  • Monogamous relationship with a vasectomized partner. The partner must havebeen vasectomized for at least 6 months prior to the participant's trialenrollment.
  1. Females of "childbearing potential" or non-sterilized males, who refuse to use an "acceptable contraceptive method" up to 6 weeks post second IMP administration onDay 90 (M3). In addition, they must be advised not to donate ova or sperm duringthis period.

  2. A first degree relative is involved in the conduct of this trial.

Study Design

Total Participants: 186
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2/3
Study Start date:
January 31, 2025
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • PS Clinic

    Fukuoka-shi, Fukuoka
    Japan

    Active - Recruiting

  • Saitama City Hospital

    Saitama-shi, Saitama
    Japan

    Active - Recruiting

  • Tamura Clinic

    Suginami-ku, Tokyo
    Japan

    Site Not Available

  • Sumida Hospital

    Sumida-ku, Tokyo
    Japan

    Active - Recruiting

  • OKURA Otolaryngology Clinic

    Toshima-ku, Tokyo
    Japan

    Active - Recruiting

  • PS Clinic

    Fukuoka,
    Japan

    Site Not Available

  • Saitama City Hospital

    Saitama,
    Japan

    Site Not Available

  • Tamura Clinic

    Tokyo,
    Japan

    Active - Recruiting

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