Safety and Immunogenicity of Different Schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Healthy Participants

NCT02302066 | Completed Phase 2 Results DMC

• 4 other identifiers: DEN-204PHRR140804-000219U1111-1154-24752018-003978-28
• Study Type: interventional
• Target: 1,800
• Locations: 3 countries
• Sites: 3

Brief Summary

The purpose of this study is to assess the humoral immune responses to three different dose schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) administered subcutaneously in healthy participants between 2 and \<18 years of age living in dengue endemic countries.

Conditions

Dengue Fever

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset

  GMTs of neutralizing antibodies were measured by microneutralization test 50% \[MNT50\] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. Data reported for up to Month 48 was collected at Months 1, 3, 6, 12, 13, 18, 24, 36 and 48.

  Up to Month 48

Secondary Outcomes (8)

• Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset

  Months 1, 3, 6, 12, 13, 18, 24, 36, and 48

• Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination

  Within 7 days after each vaccination

• Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination

  Within 7 days after each vaccination

• Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination

  Within 14 days after each vaccination

• Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination

  Within 14 days after each vaccination

Study Arms (4)

Group 1 (TDV 2-Dose)

EXPERIMENTAL

Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching vaccine, 0.5 mL, subcutaneous injection on Day 365.

Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV); Biological: TDV Placebo

Group 2 (TDV 1-Dose)

EXPERIMENTAL

Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Day 1. Placebo-matching vaccine, 0.5 mL, subcutaneous injection on Days 91 and 365.

Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV); Biological: TDV Placebo

Group 3 (TDV 1-Dose + Booster)

EXPERIMENTAL

Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching vaccine, 0.5 mL, subcutaneous injection on Day 91.

Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV); Biological: TDV Placebo

Group 4 (Placebo Control)

PLACEBO COMPARATOR

Placebo-matching vaccine, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.

Biological: TDV Placebo

Interventions

Takeda's Tetravalent Dengue Vaccine Candidate (TDV) BIOLOGICAL

TDV subcutaneous injection

Group 1 (TDV 2-Dose); Group 2 (TDV 1-Dose); Group 3 (TDV 1-Dose + Booster)

TDV Placebo BIOLOGICAL

Placebo-matching vaccine

Group 1 (TDV 2-Dose); Group 2 (TDV 1-Dose); Group 3 (TDV 1-Dose + Booster); Group 4 (Placebo Control)

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Is aged 2 to \<18 years, at the time of enrolment.
• 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.
• The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form (and assent form, where required) and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
• Can comply with trial procedures and are available for the duration of follow-up.

You may not qualify if:

• Febrile illness (temperature ≥ 38°C or 100.4°F) or moderate or severe acute illness or infection at the time of enrolment. Trial entry should be delayed until the illness has improved.
• Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the trial or pose additional risk to the participants due to participation in the trial, including but not limited to: a. Known hypersensitivity or allergy to any of the vaccine components; b. Female participants who are pregnant or breastfeeding; c. Individuals with any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin-dependent diabetes, cardiac, renal or hepatic disease, neurologic or seizure disorder or Guillain-Barré syndrome); d. Known or suspected impairment/alteration of immune function, including: i. Chronic use of oral steroids (Equivalent to 20 mg/day prednisone ≥ 12 weeks / ≥ 2 mg/kg body weight / day prednisone ≥ 2 weeks) within 60 days prior to Day 1 (use of inhaled, intranasal, or topical corticosteroids is allowed); ii. Receipt of parenteral steroids (Equivalent to 20 mg/day prednisone ≥ 12 weeks / ≥ 2 mg/kg body weight / day prednisone ≥ 2 weeks) within 60 days prior to Day 1; iii. Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the investigational vaccine or planned administration during the trial; iv. Receipt of immunostimulants within 60 days prior to Day 1; v. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months preceding (first) vaccination; vi. Human immunodeficiency virus (HIV) infection or HIV-related disease; vii. Genetic immunodeficiency.
• Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or who are planning to receive any vaccine within 28 days of investigational vaccine administration.
• Individuals participating in any clinical trial with another investigational product 30 days prior to first trial visit or intent to participate in another clinical trial at any time during the conduct of this trial.
• Individuals who are first degree relatives of individuals involved in trial conduct.
• If female of childbearing potential, sexually active, and has not used any of the "acceptable contraceptive methods" for at least 2 months prior to trial entry: a. Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: menopausal (for at least 2 years), bilateral tubal ligation (at least 1 year previously), bilateral oophorectomy (at least 1 year previously) or hysterectomy; b. Acceptable birth control methods are defined as one or more of the following: i. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring); ii. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse; iii. Intrauterine device (IUD); iv. Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the participants' trial entry.
• If female of childbearing potential, sexually active and refuses to use an "acceptable contraceptive method" through to 6 weeks after the last dose of investigational vaccine.
• Individuals who participated in a previous dengue vaccine trial.

Sponsors & Collaborators

• Takeda: lead

Study Sites (3)

Hospital Maternidad Nuestra Senora de la Altagracia

Santo Domingo, Distrito Nacional Santo Domingo, 10204, Dominican Republic

Location

Centro De Vacunacion Internacional, S.A.(CEVAXIN)

Panama City, 10662, Panama

Location

Dela Salle Health Sciences Institute

Dasmariñas, Cavite, 4114, Philippines

Location

Related Publications (6)

• Rauscher M, Youard Z, Faccin A, Patel SS, Pang H, Zent O. Pregnancy outcomes following unintentional exposure to TAK-003, a live-attenuated tetravalent dengue vaccine. Expert Rev Vaccines. 2025 Dec;24(1):221-229. doi: 10.1080/14760584.2025.2480297. Epub 2025 Mar 27.

  PMID: 40099800 DERIVED

• Tricou V, Gottardo R, Egan MA, Clement F, Leroux-Roels G, Saez-Llorens X, Borkowski A, Wallace D, Dean HJ. Characterization of the cell-mediated immune response to Takeda's live-attenuated tetravalent dengue vaccine in adolescents participating in a phase 2 randomized controlled trial conducted in a dengue-endemic setting. Vaccine. 2022 Feb 16;40(8):1143-1151. doi: 10.1016/j.vaccine.2022.01.016. Epub 2022 Jan 22.

  PMID: 35078666 DERIVED

• Tsuji I, Dominguez D, Egan MA, Dean HJ. Development of a Novel Assay to Assess the Avidity of Dengue Virus-Specific Antibodies Elicited in Response to a Tetravalent Dengue Vaccine. J Infect Dis. 2022 May 4;225(9):1533-1544. doi: 10.1093/infdis/jiab064.

  PMID: 33534885 DERIVED

• Tricou V, Saez-Llorens X, Yu D, Rivera L, Jimeno J, Villarreal AC, Dato E, Saldana de Suman O, Montenegro N, DeAntonio R, Mazara S, Vargas M, Mendoza D, Rauscher M, Brose M, Lefevre I, Tuboi S, Borkowski A, Wallace D. Safety and immunogenicity of a tetravalent dengue vaccine in children aged 2-17 years: a randomised, placebo-controlled, phase 2 trial. Lancet. 2020 May 2;395(10234):1434-1443. doi: 10.1016/S0140-6736(20)30556-0. Epub 2020 Mar 17.

  PMID: 32197107 DERIVED

• Saez-Llorens X, Tricou V, Yu D, Rivera L, Jimeno J, Villarreal AC, Dato E, Mazara S, Vargas M, Brose M, Rauscher M, Tuboi S, Borkowski A, Wallace D. Immunogenicity and safety of one versus two doses of tetravalent dengue vaccine in healthy children aged 2-17 years in Asia and Latin America: 18-month interim data from a phase 2, randomised, placebo-controlled study. Lancet Infect Dis. 2018 Feb;18(2):162-170. doi: 10.1016/S1473-3099(17)30632-1. Epub 2017 Nov 6.

  PMID: 29122463 DERIVED

• Saez-Llorens X, Tricou V, Yu D, Rivera L, Tuboi S, Garbes P, Borkowski A, Wallace D. Safety and immunogenicity of one versus two doses of Takeda's tetravalent dengue vaccine in children in Asia and Latin America: interim results from a phase 2, randomised, placebo-controlled study. Lancet Infect Dis. 2017 Jun;17(6):615-625. doi: 10.1016/S1473-3099(17)30166-4. Epub 2017 Mar 30.

  PMID: 28365225 DERIVED

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

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Program Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: November 26, 2014
• Study Start: December 5, 2014
• Primary Completion: February 18, 2019
• Study Completion: February 18, 2019
• Last Updated: February 24, 2020
• Results First Posted: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share

Locations

PH (1); DO (1); PA (1)