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

NCT06741683 | Completed Phase 2

• 3 other identifiers: DEN-3242024-000341-27jRCT2071240088
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 5

Brief 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).

Conditions

Dengue Fever

Outcome Measures

Primary Outcomes (1)

• Percentage of Seropositive Participants for Each of the 4 Dengue Virus Serotypes on Day 120

  Seropositivity is defined as a reciprocal neutralizing titer greater than or equal to (\>=) 10. The 4 dengue virus serotypes (DENV) are DENV-1, DENV-2, DENV-3 and DENV-4.

  Day 120

Secondary Outcomes (10)

• Percentage of Seropositive Participants for Each of the 4 Dengue Virus Serotypes on Day 1, Day 30, Day 90 and Day 270

  Day 1, Day 30, Day 90 and Day 270

• Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Virus Serotypes on Day 1, Day 30, Day 90, Day 120 and Day 270

  Day 1, Day 30, Day 90, Day 120 and Day 270

• Percentage of Seropositive Participants for Multiple (2, 3, or 4) Dengue Serotypes on Day 1, Day 30, Day 90, Day 120 and Day 270

  Day 1, Day 30, Day 90, Day 120 and Day 270

• Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 days After Vaccination at Day 1 and Day 90

  For 7 days after vaccination at Day 1 and Day 90

• Number of Participants with Solicited Local (Injection Site) AEs by Severity for 7 days After Vaccination at Day 1 and Day 90

  For 7 days after vaccination at Day 1 and Day 90

Study Arms (3)

Cohort 1: TDV 0.5 mL

EXPERIMENTAL

Participants with the age group 18 to 60 years will receive TDV, 0.5 milliliter (mL) subcutaneous (SC) injections, on Day 1 and Day 90.

Biological: TDV

Cohort 1: Placebo

PLACEBO COMPARATOR

Participants with the age group 18 to 60 years will receive placebo (normal saline), 0.5 mL SC injections, on Day 1 and Day 90.

Other: Placebo

Cohort 2: TDV 0.5 mL

EXPERIMENTAL

Participants with the age group 4 to 17 years will receive TDV, 0.5 mL SC injections, on Day 1 and Day 90.

Biological: TDV

Interventions

TDV BIOLOGICAL

TDV SC injection.

Also known as: TAK-003

Cohort 1: TDV 0.5 mL; Cohort 2: TDV 0.5 mL

Placebo OTHER

Placebo SC injection.

Also known as: Placebo SC injection.

Cohort 1: Placebo

Eligibility Criteria

• Age: 4 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Note: In principle, oral temperature should be measured for body temperature. In cases where it is difficult to measure oral temperature, such as in young children, underarm (axillary) temperature may be used instead.
• 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.
• Receipt of blood, immunoglobulins, blood products, and/or plasma derivatives within the 90 days prior to Day 1 (M0).
• Receipt of immunostimulants within 60 days prior to Day 1 (M0).
• Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (M0).
• Reported or known symptomatic HIV infection or asymptomatic HIV infection when accompanied by evidence of impaired immune function.
• Reported or known Hepatitis B and/or Hepatitis C virus infection.
• Genetic immunodeficiency.

Sponsors & Collaborators

• Takeda: lead

Study Sites (5)

PS Clinic

Fukuoka, Fukuoka, Japan

Location

Saitama City Hospital

Saitama-shi, Saitama, Japan

Location

Sumida Hospital

Sumida-ku, Tokyo, Japan

Location

OKURA Otolaryngology Clinic

Toshima-ku, Tokyo, Japan

Location

Tamura Clinic

Tokyo, Japan

Location

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Cohort 1 is randomized and double-blinded. Cohort 2 is non-randomized and open label.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 19, 2024
• Study Start: January 31, 2025
• Primary Completion: July 9, 2025
• Study Completion: December 17, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

JP (5)