Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) at the End of Shelf Life in Healthy Adults
Condition: Dengue Fever
MeSH terms: Dengue
Intervention: Tetravalent Dengue Vaccine (TDV)
Intervention description: TDV SC injection.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Live Attenuated Tetravalent Dengue Vaccine

Summary:

      The purpose of this study is to evaluate the safety and immune response of a naturally aged
      lot of tetravalent dengue vaccine (TDV) in healthy participants, aged 18 to 60 years, in
      non-endemic country(ies) for dengue.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants who are 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. Participants who sign and date 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. Participants with a clinically significant active infection (as assessed by the
             investigator) or body temperature ≥38°C (≥100.4°F) within 3 days of the intended date
             of vaccine administration

          2. Known or suspected impairment/alteration of immune function, including:

               1. Chronic use of oral steroids (equivalent to 20 mg/day prednisone ≥12 weeks and/or
                  ≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1
                  (Month 0) (use of inhaled, intranasal, or topical corticosteroids is allowed).

               2. Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks
                  and/or ≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day
                  1 (Month 0).

               3. Administration of immunoglobulins and/or any blood products within the 3 months
                  prior to Day 1 (Month 0) or planned administration during the trial.

               4. Receipt of immunostimulants within 60 days prior to Day 1 (Month 0).

               5. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy
                  within 6 months prior to Day 1 (Month 0).

               6. Known Human Immunodeficiency Virus (HIV) infection or HIV-related disease.

               7. Hepatitis C virus infection.

               8. Genetic immunodeficiency.

          3. With Body Mass Index (BMI) greater than or equal to 35 kg/m^2(=weight in kg/height in
             meters^2).

          4. Participants who have known hypersensitivity or allergy to any of the vaccine
             components.

          5. Previous and planned vaccination (during the trial conduct), against any flavivirus
             including dengue, Yellow Fever (YF), Japanese Encephalitis (JE) viruses or tick-borne
             encephalitis.

          6. 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.

          7. With a current or previous infection with a flavivirus such as dengue, Zika, YF, JE,
             WN fever, tick-borne encephalitis or Murray Valley encephalitis and participants with
             a history of prolonged (≥1 year) habitation in a dengue endemic area.

          8. Participants with any history of progressive or severe neurologic disorder, seizure
             disorder or neuro-inflammatory disease (e.g., Guillain-Barré syndrome).

          9. Participants with history of substance or alcohol abuse within the past 2 years.

         10. Participants who have any serious chronic or progressive disease according to judgment
             of the Investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or
             hepatic disease).