Safety and Immunogenicity With Two Different Serotype 2 Potencies of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Adults in Singapore
Condition: Dengue Fever
MeSH terms: Dengue
Intervention: Takeda's Tetravalent Dengue Vaccine Candidate (TDV); Takeda's High-Dose Tetravalent Dengue Vaccine Candidate (HD-TDV)
Intervention description: TDV subcutaneous injection; High-dose TDV subcutaneous injection
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 351.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine

Summary:

      The purpose of this study is to assess the post-vaccination neutralizing antibody response
      against each dengue serotype by vaccine group.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant signs and dates a written informed consent form where applicable, 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.

          2. Is aged 21 to 45 years of age, inclusive.

          3. Is in good health at the time of entry into the trial as determined by medical
             history, physical examination (including vital signs) and clinical judgment of the
             Investigator.

          4. Can comply with trial procedures and are available for the duration of follow-up.

          5. Has self-declared as never having been vaccinated against Yellow Fever or Japanese
             Encephalitis Virus.

        Exclusion Criteria:

          1. Has febrile illness (temperature ≥38°C or ≥100.4°F) or moderate or severe acute
             illness or infection at the time of enrollment.

          2. Has history or any illness that, in the opinion of the Investigator, might interfere
             with the results of the trial or pose an additional risk to the participant due to
             participation in the trial, including but not limited to:

               1. Known hypersensitivity or allergy to any of the vaccine components.

               2. Female participants who are pregnant or breastfeeding.

               3. Individuals with any serious chronic or progressive disease according to judgment
                  of the Investigator (e.g. neoplasm, insulin-dependent diabetes, cardiac, renal or
                  hepatic disease, neurologic or seizure disorder or Guillain-Barré syndrome).

               4. Known or suspected impairment/alteration of immune function, including:

                    -  i. 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 (Month 0) (use of inhaled, intranasal, or topical corticosteroids is
                       allowed).

                    -  ii. 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 (Month 0).

                    -  iii. Administration of immunoglobulins and/or any blood products within the
                       3 months prior to Day 1 (Month 0) or planned administration during the
                       trial.

                    -  iv. Receipt of immunostimulants within 60 days prior to Day 1(Month 0).

                    -  v. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation
                       therapy within 6 months prior to Day 1 (Month 0).

                    -  vi. Human immunodeficiency virus (HIV) infection and HIV-related diseases.

                    -  vii. Hepatitis C virus (HCV) infection.

                    -  viii. Genetic immunodeficiency.

          3. Has received any other vaccine within 14 days (for inactivated vaccines) or 28 days
             (for live vaccines) prior to Day 1 (Month 0) or planning to receive any vaccine within
             28 days after Day 1 (Month 0).

          4. Has participated in any clinical trial with another investigational product 30 days
             prior to Day 1 (Month 0) or intent to participate in another clinical trial at any
             time during the conduct of this trial.

          5. Has previously participated in any clinical trial of a dengue candidate vaccine, or
             previous receipt of a dengue vaccine.

          6. Is first-degree relative of individuals involved in trial conduct.

          7. For females of childbearing potential who are sexually active, and who have not used
             any of the acceptable contraceptive methods for at least 2 months prior to Day 1
             (Month 0).

               1. Of childbearing potential is defined as status post onset of menarche and not
                  meeting any of the following conditions: bilateral tubal ligation (at least 1
                  year previously), bilateral oophorectomy (at least 1 year previously) or
                  hysterectomy.

               2. Acceptable birth control methods are defined as one or more of the following:

                    -  i. Hormonal contraceptive (such as oral, injection, transdermal patch,
                       implant, cervical ring).

                    -  ii. Barrier (condom with spermicide or diaphragm with spermicide) each and
                       every time during intercourse.

                    -  iii. Intrauterine device (IUD).

                    -  iv. Monogamous relationship with vasectomized partner (partner must have
                       been vasectomized for at least six months prior to Day 1 [Month 0]).

          8. Females of childbearing potential who are sexually active, and who refuse to use an
             acceptable contraceptive method from signing the informed consent up to 6 weeks
             post-vaccination.