Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) in Adolescents in Non-Endemic Area(s)
Condition: Dengue
MeSH terms: Dengue
Intervention: Tetravalent Dengue Vaccine (TDV); Placebo
Intervention description: TDV subcutaneous injection; Normal Saline (0.9% NaCl) subcutaneous injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 400.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study was to describe the neutralizing antibody response against each
      dengue serotype at 1 month post second dose of TDV or placebo in dengue-naive adolescent
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The participant is aged 12 to 17 years, inclusive;

          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.

          3. The participant/the participant's legally authorized representative (LAR) signs and
             dates a written, informed consent/assent 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.

          4. Individuals who can comply with trial procedures and are available for the duration of
             follow-up.

        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.

          3. Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the
             Investigator, may interfere with the participant's ability to participate in the
             trial.

          4. Has any history of progressive or severe neurologic disorder, seizure disorder or
             neuro-inflammatory disease (e.g., Guillain-Barre syndrome).

          5. 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 participant due to
             participation in the trial.

          6. Has 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 immune-stimulants within 60 days prior to Day 1 (M0).

               5. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy
                  within 6 months prior to Day 1 (M0).

               6. Human immunodeficiency virus (HIV) infection or HIV-related disease.

               7. Genetic immunodeficiency.

          7. Has abnormalities of splenic or thymic function.

          8. Has a known bleeding diathesis, or any condition that may be associated with a
             prolonged bleeding.

          9. Has any serious chronic or progressive disease according to judgment of the
             Investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic
             disease).

         10. Has body mass index (BMI) greater than or equal to 35 kg/m^2 (= weight in kg/[height
             in square meters]).

         11. Individuals participating in any clinical trial with another investigational product
             30 days prior to Day 1 (M0) or intent to participate in another clinical trial at any
             time during the conduct of this trial.

         12. Has received any other vaccine 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 trial vaccine administration.

         13. Individuals involved in the trial conduct or their first degree relatives.

         14. Has history of substance or alcohol abuse within the past 2 years.

         15. Female participants who are pregnant or breastfeeding.

         16. 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 (M0).

         17. Females of childbearing potential who are sexually active, and who refuse to use an
             acceptable contraceptive method up to 6 weeks after the last dose of trial vaccine. In
             addition, they must be advised not to donate ova during this period.

         18. Any positive or indeterminate pregnancy test.

         19. Previous and planned vaccination (during the trial conduct), against any flaviviruses
             including dengue, yellow fever (YF), Japanese encephalitis (JE) viruses or tick-borne
             encephalitis.

         20. Previous participation in any clinical trial of a dengue or other flavivirus (eg, West
             Nile [WN] virus) candidate vaccine, except for participants who received placebo in
             those trials.

         21. Participants with documented or suspected disease caused by a flavivirus such as
             dengue, Zika, YF, JE, WN fever, tick-borne encephalitis or Murray Valley encephalitis.