A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and Toddlers

NCT06665035 | Recruiting Phase 3 DMC

• 2 other identifiers: DEN-3062023-001084-54
• Study Type: interventional
• Target: 212
• Locations: 2 countries
• Sites: 4

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 purpose of this study is to collect information of vaccination with TDV when given to children younger than 2 years. The main aims of this study are to learn how safe the vaccine is and how well it works to activate a young child's immune system (this is called immunogenicity). Children between the age of 6 and 21 months will receive two vaccinations with either TDV or placebo 3 months apart. Blood samples will be taken before and after the vaccination as well as throughout the study. These are necessary to check how well the vaccine works to activate the immune system. During the study, participants will visit their study clinic 8 times for vaccinations, blood draws and health checks.

Conditions

Dengue Fever

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (9)

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

  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 of severity will be graded by investigator as 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 Within 7 Days Post Vaccination at Day 90 (Overall and by Severity)

  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 of severity will be graded by investigator as 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 Within 14 Days Post Vaccination at Day 1 (Overall and by Severity)

  Solicited systemic AEs include fever (body temperature greater than or equal to \[\>=\] 38-degree Celsius \[C\], drowsiness, irritability/fussiness and loss of appetite. The AEs of severity will be graded by investigator as 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 Within 14 Days Post Vaccination at Day 90 (Overall and by Severity)

  Solicited systemic AEs include fever (body temperature \>= 38 degree (C), drowsiness, irritability/fussiness and loss of appetite. The AEs of severity will be graded by investigator as Grade 1: mild, Grade 2: moderate and Grade 3: severe.

  Within 14 days post-vaccination at Day 90

• Percentage of Participants with 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 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 Medically-attended AEs (MAAEs)

  MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department (medically attended visits), but not fulfilling seriousness criteria.

  From Day 1 through the end of trial (up to Day 1170)

• Percentage of Participants with Serious Adverse Events (SAEs)

  SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above-mentioned criteria.

  From Day 1 through the end of trial (up to Day 1170)

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

  GMTs of neutralizing antibodies will be measured by MNT against 4 dengue virus serotypes. The 4 dengue virus serotypes are dengue virus (DENV-1, DENV-2, DENV-3 and DENV-4) will be reported.

  Day 120

Secondary Outcomes (3)

• GMTs of Neutralizing Antibodies by MNT for Each of the 4 Dengue Virus Serotypes

  Day 1, Day 30, Day 270, Day 450, Day 810 and Day 1170

• Seropositivity Rates for 4 Dengue Virus Serotypes

  Day 1, Day 30, Day 120, Day 270, Day 450, Day 810 and Day 1170

• Seropositivity Rates For Multiple (2, 3, or 4) Dengue Virus Serotypes

  Day 1, Day 30, Day 120, Day 270, Day 450, Day 810 and Day 1170

Study Arms (4)

Cohort 1: Tetravalent Dengue Vaccine (TDV) 0.5 mL (Age group: >=12 to <21 months)

EXPERIMENTAL

Participants with the age group \>= 12 to \< 21 months receive TDV 0.5 mL subcutaneous (SC) injection, on Day 1 and Day 90.

Biological: TDV

Cohort 1: Placebo (Age group: >=12 to <21 months)

EXPERIMENTAL

Participants with the age group \>= 12 to \< 21 months receive placebo (normal saline), SC injection, on Day 1 and Day 90.

Other: Placebo

Cohort 2: TDV 0.5 mL(Age group: >=6 to <12 months)

EXPERIMENTAL

Participants with the age group \>=6 to \<12 months receive TDV, 0.5 mL SC injection, on Day 1 and Day 90.

Biological: TDV

Cohort 2: Placebo (Age group: >=6 to <12 months)

EXPERIMENTAL

Participants with the age group \>=6 to \<12 months receive placebo (normal saline), SC injection, on Day 1 and Day 90.

Other: Placebo

Interventions

TDV BIOLOGICAL

TDV SC injection.

Also known as: QDENGA, TAK-003

Cohort 1: Tetravalent Dengue Vaccine (TDV) 0.5 mL (Age group: >=12 to <21 months); Cohort 2: TDV 0.5 mL(Age group: >=6 to <12 months)

Placebo OTHER

Placebo SC injection.

Cohort 1: Placebo (Age group: >=12 to <21 months); Cohort 2: Placebo (Age group: >=6 to <12 months)

Eligibility Criteria

• Age: 6 Months - 20 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participant eligibility is determined according to the following criteria:
• Participant is aged \>=6 to \<21 months 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 (including vital signs), and the clinical judgment of the investigator.
• Participant's legally acceptable representative (LAR) has signed and dated a written informed consent form (ICF) 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.
• The participant and participant's LAR can comply with trial procedures and can be available for the duration of follow-up, according to the LAR.

You may not qualify if:

• Any participant who meets any of the following criteria will not qualify for randomization:
• Participant has contraindication(s), warning(s) and/or precaution(s) applicable to vaccination with TDV as specified in the investigator's brochure (IB)and/or the approved product label (as applicable) in the participating country.
• Participant has a known hypersensitivity or allergy to any of the investigational medicinal product (IMP) components (including excipients).
• 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 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 mg/kg \[milligrams per kilograms\] body weight/day prednisone \[or equivalent\] for 14 consecutive days, or, \>=20 milligram per day \[mg/day\] prednisone \[or equivalent\] for \>=14 consecutive days) within 60 days prior to Day 1 month 0 (M0) (note: use of corticosteroids by inhaled, intranasal, intraarticular, bursal, tendon injection, or topical routes is allowed).
• Receipt of blood, immunoglobulins, blood products, and/or plasma derivatives within the 3 months 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).
• HIV infection or HIV-related disease.
• Hepatitis B virus infection.
• Hepatitis C virus infection.
• Genetic immunodeficiency.

Sponsors & Collaborators

• Takeda: lead

Study Sites (4)

Clinica de la Costa Ltda

Barranquilla, Atlántico, 80020, Colombia

NOT YET RECRUITING

Centro de Estudios en Infectologia Pediatrica S.A.S

Cali, Valle del Cauca Department, 760042, Colombia

NOT YET RECRUITING

King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, 10330, Thailand

NOT YET RECRUITING

Thammasat University Hospital

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

RECRUITING

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 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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: June 16, 2025
• Primary Completion (Estimated): March 3, 2030
• Study Completion (Estimated): March 3, 2030
• Last Updated: July 15, 2025

Record last verified: 2025-07

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

TH (2); CO (2)