CompletedPhase 3

Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Administered With a Yellow Fever Vaccine in Adults

United States900 participantsStarted 2018-02-28

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

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)

Timeframe: Day 30

Trial details

NCT IDNCT03342898

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-05-09

Results submitted2020-09-11

View on ClinicalTrials.gov More Dengue trials