Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Administered With a Yellow Fever Vaccine in Adults
NCT ID: NCT03342898
Last Updated: 2020-10-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
900 participants
INTERVENTIONAL
2018-02-28
2019-05-22
Brief Summary
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Detailed Description
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The study will enroll 900 healthy participants. Participants will be randomized to 3 groups in 1:1:1 ratio and will be administered concomitantly and sequentially. The 3 groups are:
* Group 1: YF-17D vaccine + placebo concomitantly administered on Day 1, first dose of TDV administered on Day 90 and second dose of TDV administered on Day 180.
* Group 2: first dose of TDV + placebo concomitantly administered on Day 1, second dose of TDV administered on Day 90 and YF-17D vaccine administered on Day 180.
* Group 3: first dose of TDV + YF-17D vaccine concomitantly administered on Day 1, second dose of TDV administered on Day 90 and placebo administered on Day 180.
This multi-center trial will be conducted in the United States. The overall time to participate in this study is 360 days. Participants will make multiple visits to the clinic with a 6-month follow up including a final visit at Day 360 for a follow-up assessment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Group 1: YF-17D + Placebo/TDV/TDV
YF-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).
YF-17D
YF-17D SC injection.
TDV
TDV SC injection.
Placebo
Normal Saline (0.9% NaCl) SC injection.
Group 2: TDV + Placebo/TDV/YF-17D
TDV, 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.
YF-17D
YF-17D SC injection.
TDV
TDV SC injection.
Placebo
Normal Saline (0.9% NaCl) SC injection.
Group 3: TDV + YF-17D/TDV/Placebo
TDV, 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.
YF-17D
YF-17D SC injection.
TDV
TDV SC injection.
Placebo
Normal Saline (0.9% NaCl) SC injection.
Interventions
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YF-17D
YF-17D SC injection.
TDV
TDV SC injection.
Placebo
Normal Saline (0.9% NaCl) SC injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
Exclusion Criteria
2. Has contraindications, warnings and/or precautions to vaccination with the YF-17D vaccine as specified within the product information (especially history of thymus dysfunction).
3. Female participant who are pregnant or breastfeeding
4. 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.
5. Has body mass index (BMI) greater than or equal to 35 kg/m\^2 (=weight in kg/\[height in meters\^2\]).
6. Is intent to travel to dengue or YF endemic countries during the trial period.
7. 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.
8. Has previous and planned vaccination (during the trial conduct), against any flavivirus including dengue, YF, Japanese encephalitis (JE) or tick-borne encephalitis viruses.
9. 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.
10. 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.
18 Years
60 Years
ALL
Yes
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director Clinical Science
Role: STUDY_DIRECTOR
Takeda
Locations
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Coastal Clinical Research Inc
Mobile, Alabama, United States
Empire Clinical Research
Pomona, California, United States
Advanced Clinical Research
Meridian, Idaho, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
Center for Pharmaceutical Research
Kansas City, Missouri, United States
Meridian Clinical Research LLC
Omaha, Nebraska, United States
Regional Clinical Research Inc.
Endwell, New York, United States
Rapid Medical Research Inc
Cleveland, Ohio, United States
Tekton Research
Austin, Texas, United States
Advanced Clinical Research
West Jordan, Utah, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States
Countries
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References
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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.
Tricou 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1201-5257
Identifier Type: REGISTRY
Identifier Source: secondary_id
DEN-305
Identifier Type: -
Identifier Source: org_study_id
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