Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Administered With a Yellow Fever Vaccine in Adults
Condition: Dengue
MeSH terms: Dengue; Yellow Fever
Intervention: YF-17D; TDV; Placebo
Intervention description: YF-17D SC injection.; TDV SC injection.; Normal Saline (0.9% NaCl) SC injection.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 900.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is aged 18 to 60 years inclusive, at the time of randomization.

          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:

          1. Has an elevated oral temperature ≥ 38°C (100.4°F) within 3 days of the intended date
             of vaccination.

          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.