A Study of Dengue Tetravalent Vaccine (TDV) in Adults (Age 45 to 60 and >60 to 79 Years)

NCT06579755 | Recruiting Phase 3 DMC

• 1 other identifier: DEN-321
• Study Type: interventional
• Target: 800
• Locations: 4 countries
• Sites: 7

Brief Summary

Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. Researchers have seen that dengue fever now also happens more often in elderly persons. The main aim of this study is to learn more about the side effects of TDV in adult (45 - 60 years) and elderly (60 - 79 years) persons and about TDV's ability to create an immune response in adult and elderly persons. Another aim is to learn about the side effects of TDV in adult and elderly persons in endemic countries who have one or more additional medical conditions (called comorbidities) such as diabetes mellitus, hypertension or a chronic kidney condition. 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.

Conditions

Dengue Fever

Keywords

Vaccination

Outcome Measures

Primary Outcomes (12)

• Number of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 1

  An AE is defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medical product (IMP); it does not necessarily have to have a causal relationship with IMP administration. Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration.

  Within 7 days post-vaccination at Day 1

• Number of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 90

  Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration.

  Within 7 days post-vaccination at Day 90

• Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 1

  Solicited systemic AEs include fever (body temperature greater than or equal to \[\>=\] 38 degree Celsius \[C\], asthenia, malaise, headache, and myalgia.

  Within 14 days post-vaccination at Day 1

• Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 90

  Solicited systemic AEs include fever (body temperature \>= 38 degree (C), asthenia, malaise, headache, and myalgia.

  Within 14 days post-vaccination at Day 90

• Percentage of Participants with Solicited Local (Injection Site) AEs by Severity Within 7 Days Post Vaccination at Day 1

  Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.

  Within 7 days post-vaccination at Day 1

• Percentage of Participants with Solicited Local (Injection Site) AEs by Severity Within 7 Days Post Vaccination at Day 90

  Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.

  Within 7 days post-vaccination at Day 90

• Percentage of Participants with Solicited Systemic AEs by Severity Within 14 Days Post Vaccination at Day 1

  Solicited systemic AEs include fever (body temperature \>= 38 degree (C), asthenia, malaise, headache, and myalgia. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.

  Within 14 days post-vaccination at Day 1

• Percentage of Participants with Solicited Systemic AEs by Severity Within 14 Days Post Vaccination at Day 90

  Solicited systemic AEs include fever (body temperature \>= 38 degree (C), asthenia, malaise, headache, and myalgia. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.

  Within 14 days post-vaccination at Day 90

• Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination at Day 1

  An unsolicited AE is any AE reported by the participant that is not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting a solicited AE (that is, 7 days and 14 days in total including the day IMP administration).

  Within 28 days post-vaccination at Day 1

• Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination at Day 90

  An unsolicited AE is any AE reported by the participant that is not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting a solicited AE (that is, 7 days and 14 days in total including the day of IMP administration).

  Within 28 days post-vaccination at Day 90

• Percentage of Participants with a Serious Adverse Event (SAE)

  An SAE is defined as any untoward medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, is an important medical event.

  From first vaccination on Day 1 through the end of trial (up to Day 270)

• Geometric Mean Titers (GMTs) of Neutralizing Antibodies by Microneutralization Test (MNT) for Each of the 4 Dengue Virus Serotypes at Day 120

  GMTs of neutralizing antibodies will be measured by microneutralization test 50% \[MNT50\] for each of the 4 Dengue Serotypes in all participants. The 4 dengue virus serotypes are dengue virus (DENV)-1, DENV-2, DENV-3 and DENV-4.

  At Day 120

Secondary Outcomes (12)

• Number of Participants with Solicited Local (Injection Site) AEs Within 7 Days Post Vaccination at Day 1 and Day 90 (With Comorbidities)

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

• Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 1 and Day 90 (With Comorbidities)

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

• Percentage of Participants with Solicited Local (Injection Site) AEs by Severity Within 7 days Post Vaccination at Day 1 and Day 90 (With Comorbidities)

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

• Percentage of Participants with Solicited Systemic AEs by Severity (With Comorbidities)

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

• Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination (With Comorbidities)

  Within 28 days post-vaccination at Day 1 and Day 90

Study Arms (3)

Cohort 1: Tetravalent Dengue Vaccine (TDV) 0.5 mL

EXPERIMENTAL

Participants with the age group greater than (\>) 60 to 79 years will receive TDV, 0.5 mL subcutaneous (SC) injections, on Day 1 and Day 90.

Biological: TDV

Cohort 1: Placebo

PLACEBO COMPARATOR

Participants with the age group \>60 to 79 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 45 to 60 years will receive TDV, 0.5 mL SC injection, on Day 1 and Day 90.

Biological: TDV

Interventions

TDV BIOLOGICAL

TDV SC injection.

Also known as: TAK-003

Cohort 1: Tetravalent Dengue Vaccine (TDV) 0.5 mL; Cohort 2: TDV 0.5 mL

Placebo OTHER

Placebo SC injection.

Cohort 1: Placebo

Eligibility Criteria

• Age: 45 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is aged 45 to 79 years at the time of entry into the trial.
• Participant is male or female.
• Participant is in good health or has a medical diagnosis of one or more of diabetes mellitus, hypertension, or chronic kidney disease (that is, comorbidities) and are medically stable in the opinion of the investigator at the time of entry into the trial, as determined by medical history and targeted physical examination. Medically stable is defined as no change in diagnoses or chronic medications (dose or class) for medical reasons in the 3 months prior to participating in the trial.
• Participant has signed and dated a written informed consent form and any required privacy authorization prior to the initiation of any trial procedure, 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 Investigator's Brochure and/or approved product label (as applicable) in the participating country.
• Participant has a known hypersensitivity or allergy to any of the TDV or placebo 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 (example, 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 or equal to \[\>=\] 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 (month \[M0\]) (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.
• Participant has known or suspected abnormalities of splenic or thymic function.

Sponsors & Collaborators

• Takeda: lead

Study Sites (7)

Fundacion Huesped - PPDS

Buenos Aires, C1427CEA, Argentina

RECRUITING

Associacao Obras Sociais Irma Dulce Hospital Santo Antonio

Salvador, Estado de Bahia, 40444-130, Brazil

RECRUITING

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS

São José do Rio Preto, São Paulo, 15090-000, Brazil

RECRUITING

Singapore General Hospital (SGH)

Singapore, 169608, Singapore

RECRUITING

Tan Tock Seng Hospital

Singapore, 308433, Singapore

RECRUITING

Ramathibodi Hospital

Ratchathewi, Bangkok, 10400, Thailand

RECRUITING

Hospital for Tropical Diseases

Ratchathewi, Krung Thep Maha Nakhon-Bangkok, 10400, Thailand

RECRUITING

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.
• Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.

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

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• 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: August 29, 2024
• First Posted: August 30, 2024
• Study Start: January 20, 2026
• Primary Completion (Estimated): April 14, 2027
• Study Completion (Estimated): April 14, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

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

SG (2); AR (1); TH (2); BR (2)