Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America
Condition: Dengue; Dengue Hemorrhagic Fever; Dengue Virus; Dengue Fever
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Intervention: CYD Dengue Vaccine; Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis
Intervention description: 0.5 mL, Subcutaneous at Day 0, 6 and 12 months; NaCl: 0.5 mL, Intramuscular at Day 0 and 6 months; Adacel®: 0.5 mL, Intramuscular at 12 months
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 600.0
Sex: All
Minimum age: 9 Years
Maximum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dengue; Dengue hemorrhagic fever; Dengue virus; Dengue fever; Sanofi pasteur's CYD Dengue vaccine

Summary:

      Primary objectives:

        -  To describe the immune response to each dengue serotype before and after each
           vaccination with sanofi pasteur's CYD dengue vaccine.

        -  To evaluate the safety of each vaccination with sanofi pasteur's CYD dengue vaccine.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Aged 9 to 16 years on the day of inclusion

          -  Subject in good health, based on medical history and physical examination

          -  Provision of assent form/informed consent form signed by the subject and by the
             parent(s) or another legally acceptable representative

          -  Subject and parent(s)/legally acceptable representative(s) able to attend all
             scheduled visits and to comply with all trial procedures

          -  For a female subject of child-bearing potential, avoid becoming pregnant (use of an
             effective method of contraception or abstinence) for at least 4 weeks prior to first
             vaccination until at least 4 weeks after the last vaccination.

        Exclusion Criteria :

          -  Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia

          -  For a female subject of child-bearing potential, known pregnancy or positive urine
             pregnancy test at Visit 1

          -  Participation in another clinical trial investigating a vaccine, drug, medical device,
             or a medical procedure in the 4 weeks preceding the first trial vaccination

          -  Breast-feeding woman

          -  Planned participation in another clinical trial during the present trial period

          -  Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy
             such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months,
             or long-term systemic corticosteroids therapy

          -  Known systemic hypersensitivity to any of the components of any of the trial vaccines
             or history of a life-threatening reaction to any of the trial vaccines or to a vaccine
             containing any of the same substances

          -  Chronic illness at a stage that could interfere with trial conduct or completion, in
             the opinion of the Investigator

          -  Current alcohol abuse or drug addiction that may interfere with the subject's ability
             to comply with trial procedures

          -  Receipt of blood or blood-derived products in the preceding 3 months that might
             interfere with the assessment of immune response

          -  Receipt of any vaccine in the 4 weeks preceding the first trial vaccination

          -  Planned receipt of any vaccine in the 4 weeks following the first trial vaccination

          -  Subject deprived of freedom by administrative or court order, or in an emergency
             setting, or hospitalized without his/her consent

          -  Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection on
             the day of vaccination, according to investigator judgment

          -  Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding
             inclusion contraindicating intramuscular vaccination

          -  Severe diseases with or without fever, convulsions or neurological abnormalities
             without treatment or in progression.