Status:
COMPLETED
Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Administered With a Yellow Fever Vaccine in Adults
Lead Sponsor:
Takeda
Conditions:
Dengue
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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 ...
Detailed Description
The vaccine tested in this study is TDV also known as TAK-003 (DENVax). TDV with concomitant and sequential administration of yellow fever (YF-17D) vaccine will be tested to assess immunogenicity and ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2019
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT03342898
Start Date
February 28 2018
End Date
May 22 2019
Last Update
October 8 2020
Active Locations (11)
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1
Coastal Clinical Research Inc
Mobile, Alabama, United States, 36608
2
Empire Clinical Research
Pomona, California, United States, 91767
3
Advanced Clinical Research
Meridian, Idaho, United States, 83462
4
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219