Study of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India
Condition: Dengue; Dengue Fever; Dengue Hemorrhagic Fever
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Intervention: Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus; Placebo: NaCl 0.9% solution
Intervention description: 0.5 mL, Subcutaneous; 0.5 ml, Subcutaneous
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 189.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dengue Fever; Dengue Hemorrhagic Fever; CYD Dengue Vaccine; Dengue Virus; Flavivirus

Summary:

      The aim of this study is to evaluate the immunogenicity and safety of the CYD dengue vaccine
      in India adult subjects.

      Primary Objectives:

        -  To describe the neutralizing antibody response to each dengue virus serotype before the
           first vaccination and after each vaccination with CYD dengue vaccine in all subjects.

        -  To describe the safety of the CYD dengue vaccine after each dose in all subjects.

      Secondary Objective:

        -  To detect symptomatic dengue cases occurring at any time in the trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 to 45 years on the day of inclusion

          -  Informed consent form has been signed and dated by the subject (and by an independent
             witness, if applicable)

          -  Subject is able to attend all scheduled visits and to comply with all trial procedures

          -  Subject in good health, based on medical history and physical examination

        Exclusion Criteria:

          -  Subject is pregnant, or lactating, or of childbearing potential (to be considered of
             non-childbearing potential, a female must be post-menopausal for at least 1 year,
             surgically sterile, or using an effective method of contraception or abstinence from
             at least 4 weeks prior to the first vaccination and until at least 4 weeks after the
             last vaccination)

          -  Participation in another clinical trial investigating a vaccine, drug, medical device,
             or medical procedure in the 4 weeks preceding the first trial vaccination

          -  Planned participation in another clinical trial during the present trial period

          -  Planned receipt of any vaccine in the 4 weeks following any trial vaccination

          -  Receipt of blood or blood-derived products in the past 3 months, which might interfere
             with assessment of the immune response

          -  Known or suspected congenital or acquired immunodeficiency; or receipt of
             immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within
             the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or
             equivalent for more than 2 consecutive weeks within the past 3 months)

          -  Known seropositivity for human immunodeficiency virus (HIV), hepatitis B, and
             hepatitis C reported by the subject

          -  Known systemic hypersensitivity to any of the vaccine components, or history of a
             life-threatening reaction to the vaccine(s) used in the trial or to a vaccine
             containing any of the same substances

          -  Chronic illness that, in the opinion of the investigator, is at a stage where it might
             interfere with trial conduct or completion

          -  Current alcohol abuse or drug addiction that might interfere with the ability to
             comply with trial procedures

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily

          -  Identified as an Investigator or employee of the Investigator or study center, with
             direct involvement in the proposed study, or identified as an immediate family member
             (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with
             direct involvement in the proposed study.