Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Administered With a Yellow Fever Vaccine in Adults
Completed · Phase 3 · Has a placebo group
Conditions studied: Dengue
In brief
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.
Key facts
- Study ID
- NCT03342898
- Run by
- Takeda
- People needed
- 900
- Starts
- 2018-02-28
- Expected to finish
- 2019-05-22
- Last updated by the study team
- 2020-10-08
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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