Safety and Immunogenicity of Different Schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Healthy Participants
Condition: Dengue Fever
MeSH terms: Dengue
Intervention: Takeda's Tetravalent Dengue Vaccine Candidate (TDV); TDV Placebo
Intervention description: TDV subcutaneous injection; Placebo-matching vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1800.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to assess the humoral immune responses to three different dose
      schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) administered subcutaneously
      in healthy participants between 2 and <18 years of age living in dengue endemic countries.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is aged 2 to <18 years, at the time of enrolment.

          2. 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.

          3. The participant or, when applicable, the participant's legally acceptable
             representative signs and dates a written, informed consent form (and assent form,
             where required) 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.

          4. Can comply with trial procedures and are available for the duration of follow-up.

        Exclusion Criteria:

          1. Febrile illness (temperature ≥ 38°C or 100.4°F) or moderate or severe acute illness or
             infection at the time of enrolment. Trial entry should be delayed until the illness
             has improved.

          2. Individuals with history or any illness that, in the opinion of the investigator,
             might interfere with the results of the trial or pose additional risk to the
             participants due to participation in the trial, including but not limited to: a. Known
             hypersensitivity or allergy to any of the vaccine components; b. Female participants
             who are pregnant or breastfeeding; c. 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); d. 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 (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; iii. Administration of immunoglobulins and/or any blood products within the three
             months preceding the first administration of the investigational vaccine or planned
             administration during the trial; iv. Receipt of immunostimulants within 60 days prior
             to Day 1; v. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation
             therapy within 6 months preceding (first) vaccination; vi. Human immunodeficiency
             virus (HIV) infection or HIV-related disease; vii. Genetic immunodeficiency.

          3. Individuals who 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 vaccine within 28 days of investigational vaccine administration.

          4. Individuals participating in any clinical trial with another investigational product
             30 days prior to first trial visit or intent to participate in another clinical trial
             at any time during the conduct of this trial.

          5. Individuals who are first degree relatives of individuals involved in trial conduct.

          6. If female of childbearing potential, sexually active, and has not used any of the
             "acceptable contraceptive methods" for at least 2 months prior to trial entry: a. Of
             childbearing potential is defined as status post onset of menarche and not meeting any
             of the following conditions: menopausal (for at least 2 years), bilateral tubal
             ligation (at least 1 year previously), bilateral oophorectomy (at least 1 year
             previously) or hysterectomy; b. 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 the participants' trial entry.

          7. If female of childbearing potential, sexually active and refuses to use an "acceptable
             contraceptive method" through to 6 weeks after the last dose of investigational
             vaccine.

          8. Individuals who participated in a previous dengue vaccine trial.