A Study on a New Tetravalent Dengue Vaccine (TDV) Formulation in Healthy Adults

NCT07047521 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: DEN-322
• Study Type: interventional
• Target: 496
• Locations: 1 country
• Sites: 5

Brief Summary

Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. The TDV in current formulation has been approved by health authorities in many countries around the world. The main aim of the study is to confirm that the TDV new formulation induces the similar immune response as approved TDV. Healthy adults who live in an area in which dengue fever does not occur will receive 2 TDV vaccinations 3-months apart with either the new or the current TDV. Blood samples will be taken before and after the vaccinations. These are necessary to check how well the vaccine works to activate the immune system. During the study, participants will visit their study clinic 5 times.

Conditions

Dengue Fever

Keywords

Vaccine

Outcome Measures

Primary Outcomes (1)

• Geometric Mean Titers (GMTs) of Neutralizing Antibodies (By MNT) Against Each of the 4 Dengue Serotypes at Day 120 In the TDV (New) And TDV (Current) Groups

  GMTs of neutralizing antibodies will be measured by microneutralization test 50% \[MNT50\] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. GMTs of neutralizing antibodies (by MNT) against each of the 4 dengue serotypes at Day 120 in the TDV (new) and TDV (current) groups will be reported.

  At Day 120

Secondary Outcomes (7)

• GMTs of Neutralizing Antibodies (By MNT) Against Each of the 4 Dengue Serotypes at Day 270 In the TDV (New) And TDV (Current) Groups

  At Day 270

• Seropositivity Rates Against Each of the 4 Dengue Serotypes at Day 120 And Day 270 In the TDV (New) And TDV (Current) Groups

  At Days 120 and 270

• Seropositivity Rates Against Multiple (2, 3 or 4) Dengue Virus Serotypes at Day 120 And Day 270 In the TDV (New) And TDV (Current) Groups

  At Days 120 and 270

• Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 days Post Vaccination (Overall and by Severity)

  Within 7 Days post-vaccination at Day 1 and Day 90

• Percentage of Participants With Solicited Systemic AEs for 14 days Post Vaccination (Overall and by Severity)

  Within 14 days post-vaccination at Day 1 and Day 90

Study Arms (2)

Tetravalent Dengue Vaccine (TDV) (New)

EXPERIMENTAL

Participants will receive TDV (new formulation) dose 1, subcutaneous injection, once on Day 1 (first dose) and Day 90 (second dose).

Biological: Tetravalent Dengue Vaccine (TDV)

Tetravalent Dengue Vaccine (TDV) (current)

EXPERIMENTAL

Participants will receive TDV (current approved formulation) 0.5 mL dose, subcutaneous injection, once on Day 1 (first dose) and Day 90 (second dose).

Biological: Tetravalent Dengue Vaccine (TDV)

Interventions

Tetravalent Dengue Vaccine (TDV) BIOLOGICAL

TDV subcutaneous injection

Also known as: TAK-003

Tetravalent Dengue Vaccine (TDV) (New); Tetravalent Dengue Vaccine (TDV) (current)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant eligibility is determined according to the following criteria:
• Participant is aged 18 to 60 years at the time of entry into the trial.
• Participant is male or female.
• Participant is in good health at the time of entry into the trial, as determined by medical history, physical examination, and the clinical judgment of the investigator.
• Participant is immunologically naive to dengue, based on negative results for the detection of anti-DENV antibodies as documented by serological testing at screening.
• Participant has signed and dated a written informed consent form (ICF) and any required privacy authorization prior to the initiation of any trial procedures, and after the nature of the trial has been explained according to local regulatory requirements.
• 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 IB and/or approved product label in the participating country.
• Participant has a known hypersensitivity or allergy to any of the Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) 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 (eg, Guillain-Barré syndrome).
• 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 altered immunocompetence, including:
• Chronic administration of oral and/or parenteral steroids at doses considered sufficiently immunosuppressive (example, greater than and equal to \[\>=\] 2 milligrams per kilograms \[mg/kg\] body weight/day prednisone \[or equivalent\] for \>=14 consecutive days or \>=20 mg/day prednisone \[or equivalent\] administered for \>=14 consecutive days) within 60 days prior to Day 1 (Month \[M\] 0) (note: use of corticosteroids by inhaled, intranasal, intra-articular, bursal, tendon injection, or topical routes is allowed).
• Receipt of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (M0) or planned administration during the trial.
• 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).
• Human immunodeficiency virus (HIV) infection or HIV-related disease.
• Hepatitis B virus infection.
• Hepatitis C virus infection.
• Genetic immunodeficiency. 7. Participant has known or suspected abnormalities of splenic or thymic function.
• \. Participant has a known bleeding diathesis or any condition/medication that may be associated with a prolonged bleeding time.

Sponsors & Collaborators

• Takeda: lead

Study Sites (5)

Paratus Clinical Research Western Sydney

Blacktown, New South Wales, 2150, Australia

Location

Emeritus Research Sydney

Botany, New South Wales, 2019, Australia

Location

Paratus Clinical Research Central Coast

Kanwal, New South Wales, 2259, Australia

Location

Veritus Research

Bayswater, Victoria, 3153, Australia

Location

Emeritus Research Camberwell (Melbourne)

Camberwell, Victoria, 3124, Australia

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

Interventions

Dengue Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

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

AU (5)