NCT02948829

Brief Summary

The purpose of this study is to assess the cellular immune responses following 2 doses given 3 months apart of tetravalent dengue vaccine candidate (TDV) in 4 to 16 years' healthy participants.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2 healthy-volunteers

Timeline
Completed

Started Apr 2017

Longer than P75 for phase_2 healthy-volunteers

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

April 3, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2017

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2020

Completed
4 months until next milestone

Results Posted

Study results publicly available

April 26, 2021

Completed
Last Updated

March 15, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

October 26, 2016

Results QC Date

March 26, 2021

Last Update Submit

February 22, 2024

Conditions

Healthy Volunteers

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Cellular Immune Response to 2 Doses of Tetravalent Dengue Vaccine (TDV) at 1 Month Post Second Vaccination

    Percentage of participants with cellular immune response were reported. Cellular immune response was defined as an interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) response that was \>3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Cellular immune response to any peptide pool was reported. The peptide pool included non-structural proteins (NS) NS3 and NS5 for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4 and NS1 for DENV-2. Percentage of participants with cellular immune response were reported. Percentages are rounded off to the nearest decimal point.

    1 month post second vaccination (Day 120)

Secondary Outcomes (19)

  • Magnitude of Cellular Immune Response Assessed by Number of Spot Forming Cells (SFC)/Million Peripheral Blood Mononuclear Cells (PBMCs) Measured by IFN-γ ELISPOT at 1 Month Post Second Vaccination

    1 month post second vaccination (Day 120)

  • Percentage of Participants With Cellular Immune Response to TDV at 1 Month Post First Vaccination, Pre-second Vaccination, 6 Months Post Second Vaccination, and Annually at Years 1, 2, and 3

    1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 6 months post second vaccination (Day 270); Years 1, 2 and 3

  • Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT at 1 Month Post First Vaccination, Pre-second Vaccination, 6 Months Post Second Vaccination, and Annually at Years 1, 2, and 3

    1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 6 months post second vaccination (Days 120 and 270); Years 1, 2 and 3

  • Percentage of Participants With Cellular Immune Responses to TDV at 1 Month Post First Vaccination, Pre-second Vaccination, 1 and 6 Months Post Second Vaccination, and Annually at Years 1, 2, and 3 Assessed by Country

    1 month post first vaccination (Day 30); pre-second vaccination (Day 90) 1 and 6 months post second vaccination (Days 120 and 270); Years 1, 2, 3

  • Percentage of Participants With Cellular Immune Responses to TDV:1 Month Post First Vaccination, Pre-second Vaccination, 1 and 6 Months Post Second Vaccination, and Annually at Years 1, 2, and 3, by Dengue Baseline Seropositivity Status

    1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); Years 1, 2, and 3

  • +14 more secondary outcomes

Study Arms (1)

Tetravalent Dengue Vaccine (TDV) 0.5 mL

EXPERIMENTAL

TDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3).

Biological: TDV

Interventions

TDVBIOLOGICAL

TDV SC injection.

Tetravalent Dengue Vaccine (TDV) 0.5 mL

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Is aged 4 to 16 years, inclusive (Latin America) or 4 to 8 years, inclusive (Asia).
  • Are in good health at the time of entry into the study as determined by medical history, physical examination (including vital signs), and clinical judgment of the investigator.

You may not qualify if:

  • Febrile illness (body temperature ≥38°C) or moderate or severe acute illness or infection at the time of enrolment.
  • History or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose an additional risk to the participant due to participation in the study.
  • Receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Day 1 (Month 0) or planning to receive any vaccines within 28 days after Day 1 (Month 0).
  • Previous participation in any clinical study of a dengue candidate vaccine, or previous receipt of any dengue vaccines (investigational or licensed).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CEVAXIN

Panama City, Panama

Location

Research Institute for Tropical Medicine

City of Muntinlupa, 1781, Philippines

Location

Related Publications (1)

  • 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: 40099800DERIVED

Results Point of Contact

Title
Study Director
Organization
Takeda
trialdisclosures@takeda.com
+1-877-825-3327

Study Officials

  • Medical Director Clinical Science

    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
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2016

First Posted

October 28, 2016

Study Start

April 3, 2017

Primary Completion

October 16, 2017

Study Completion

December 14, 2020

Last Updated

March 15, 2024

Results First Posted

April 26, 2021

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

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.
More information

Locations

PA(1)PH(1)