Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Administered With a Yellow Fever Vaccine in Adults
A Randomized, Observer-Blind, Placebo-Controlled, Phase 3 Trial to Investigate the Immunogenicity and Safety of a Tetravalent Dengue Vaccine Candidate and a Yellow Fever YF-17D Vaccine Administered Concomitantly and Sequentially in Healthy Subjects Aged 18 to 60 Years in Non-Endemic Country(Ies)
2 other identifiers
interventional
900
1 country
11
Brief Summary
The main purpose of this study is to assess the immunogenicity and safety of the concomitant and sequential administration of yellow fever (YF) vaccine and tetravalent dengue vaccine (TDV) in healthy participants aged 18 to 60 years living in country non-endemic for both dengue and YF.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2018
Shorter than P25 for phase_3
11 active sites
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
November 10, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedStudy Start
First participant enrolled
February 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2019
CompletedResults Posted
Study results publicly available
October 8, 2020
CompletedOctober 8, 2020
September 1, 2020
2 months
November 10, 2017
September 11, 2020
September 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Are YF and Dengue Virus (DENV)-Naive at Baseline and Are Seroprotected Against YF on Day 30 as Measured by Plaque Reduction Neutralization Test (PRNT)
Seroprotection was defined as reciprocal anti-YF neutralizing antibody titer ≥10. Immunological naivety to YF and DENV was defined as Baseline reciprocal neutralizing antibody titers \<10 for YF and for the 4 dengue serotypes. The 95% CI was calculated using exact Clopper-Pearson method.
Day 30
Secondary Outcomes (11)
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Pre-second and -third vaccination (Days 90 and 180, respectively); and 1 month post -first, second, and third vaccination (Days 30, 120, and 210, respectively)
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Pre-second and -third vaccination (Days 90 and 180, respectively); and 1-month post -first, -second, and -third vaccination (Days 30, 120, and 210, respectively)
Percentage of Participants Who Are Seropositive for Multiple (2, 3 or 4) Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Pre-second and -third vaccination (Days 90 and 180, respectively); and 1-month post -first, second, and -third vaccination (Days 30, 120, and 210, respectively)
Percentage of YF and DENV-naive Participants at Baseline Who Are Seroprotected Against YF on Day 210 as Measured by PRNT
1-month post third vaccination (Day 210)
Geometric Mean Titers (GMTs) of Anti-YF Neutralizing Antibodies at Day 30 in Participants YF and DENV-Naive at Baseline
1-month post-first vaccination (Day 30)
- +6 more secondary outcomes
Study Arms (3)
Group 1: YF-17D + Placebo/TDV/TDV
EXPERIMENTALYF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose).
Group 2: TDV + Placebo/TDV/YF-17D
EXPERIMENTALTDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180.
Group 3: TDV + YF-17D/TDV/Placebo
EXPERIMENTALTDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180.
Interventions
YF-17D SC injection.
TDV SC injection.
Normal Saline (0.9% NaCl) SC injection.
Eligibility Criteria
You may qualify if:
- Is aged 18 to 60 years inclusive, at the time of randomization.
- 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.
You may not qualify if:
- Has an elevated oral temperature ≥ 38°C (100.4°F) within 3 days of the intended date of vaccination.
- Has contraindications, warnings and/or precautions to vaccination with the YF-17D vaccine as specified within the product information (especially history of thymus dysfunction).
- Female participant who are pregnant or breastfeeding
- Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g., Guillain-Barre syndrome) or suspected impairment/alteration of immune function.
- Has body mass index (BMI) greater than or equal to 35 kg/m\^2 (=weight in kg/\[height in meters\^2\]).
- Is intent to travel to dengue or YF endemic countries during the trial period.
- Has 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 non-trial vaccine within 28 days of trial vaccine administration.
- Has previous and planned vaccination (during the trial conduct), against any flavivirus including dengue, YF, Japanese encephalitis (JE) or tick-borne encephalitis viruses.
- Has previous participation in any clinical trial of a dengue or other flavivirus (e.g., West Nile \[WN\] virus) candidate vaccine, except for participants who received placebo in those trials.
- Has a current or previous infection with a flavivirus such as dengue, Zika, YF, JE, WN fever, or Saint Louis encephalitis viruses and participants with a history of prolonged (≥1 year) habitation in a dengue endemic area.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (11)
Coastal Clinical Research Inc
Mobile, Alabama, 36608, United States
Empire Clinical Research
Pomona, California, 91767, United States
Advanced Clinical Research
Meridian, Idaho, 83462, United States
Johnson County Clin-Trials
Lenexa, Kansas, 66219, United States
Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
Meridian Clinical Research LLC
Omaha, Nebraska, 68134, United States
Regional Clinical Research Inc.
Endwell, New York, 13760, United States
Rapid Medical Research Inc
Cleveland, Ohio, 44122, United States
Tekton Research
Austin, Texas, 78745, United States
Advanced Clinical Research
West Jordan, Utah, 84088, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507, United States
Related Publications (2)
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: 40099800DERIVEDTricou V, Essink B, Ervin JE, Turner M, Escudero I, Rauscher M, Brose M, Lefevre I, Borkowski A, Wallace D. Immunogenicity and safety of concomitant and sequential administration of yellow fever YF-17D vaccine and tetravalent dengue vaccine candidate TAK-003: A phase 3 randomized, controlled study. PLoS Negl Trop Dis. 2023 Mar 8;17(3):e0011124. doi: 10.1371/journal.pntd.0011124. eCollection 2023 Mar.
PMID: 36888687DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2017
First Posted
November 17, 2017
Study Start
February 28, 2018
Primary Completion
May 9, 2018
Study Completion
May 22, 2019
Last Updated
October 8, 2020
Results First Posted
October 8, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will share
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.