Lot-to-lot Consistency of 3 Lots of Tetravalent Dengue Vaccine (TDV) in Non-endemic Country(Ies) for Dengue
Condition: Dengue Fever
MeSH terms: Dengue
Intervention: TAK-003; Placebo
Intervention description: TDV subcutaneous injection; TDV Placebo-matching normal saline (0.9% NaCl) subcutaneous injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: A double-blind study.
Enrollment: 923.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine

Summary:

      The purpose of this study is to investigate lot-to-lot consistency in terms of equivalence of
      the immune responses induced by 3 consecutive TDV lots in healthy participants aged 18 to 60
      years in non-endemic country(ies) for dengue.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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.

          2. Signs and dates a written informed consent form and any required privacy authorization
             prior to the initiation of any trial procedures, after the nature of the trial has
             been explained according to local regulatory requirements.

        Exclusion Criteria:

          1. Has an elevated oral temperature (≥38°C or 100.4°F) within 3 days of the intended date
             of vaccination.

          2. Known hypersensitivity or allergy to any of the vaccine components (including
             excipients of the investigational vaccine or placebo).

          3. Has any history of progressive or severe neurologic disorder, seizure disorder or
             neuro-inflammatory disease (e.g., Guillain-Barré syndrome).

          4. Known or suspected impairment/alteration of immune function, including:

               1. Chronic use of oral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥2
                  mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (M0)
                  (use of inhaled, intranasal, or topical corticosteroids is allowed)

               2. Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥ 2
                  mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (M0).

               3. Administration of immunoglobulins and/or any blood products within the 3 months
                  prior to Day 1 (M0) or planned administration during the trial.

               4. Receipt of immunostimulants within 60 days prior to Day 1 (M0).

               5. Hepatitis C virus infection.

               6. Genetic immunodeficiency.

          5. Has abnormalities of splenic or thymic function.

          6. Has a known bleeding diathesis, or any condition that may be associated with a
             prolonged bleeding time.

          7. Has any serious chronic or progressive disease according to judgment of the
             Investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic
             disease).

          8. Has body mass index (BMI) greater than or equal to 35 kg/m^2 (= weight in kg/[height
             in meters^2]).

          9. Has history of substance or alcohol abuse within the past 2 years.

         10. Had previous and planned vaccination (during the trial conduct) against any flavivirus
             including dengue, yellow fever (YF), Japanese encephalitis (JE) viruses or tick-borne
             encephalitis.

         11. Has a current or previous infection with a flavivirus such as dengue, Zika, YF, JE,
             West Nile (WN) fever, tick-borne encephalitis or Murray Valley encephalitis and
             participants with a history of prolonged (≥1 year) habitation in a dengue endemic
             area.