Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America
Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America
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.
The antibody levels against each serotype will be measured before and after each vaccination.
 The subjects will be followed for 28 days after each vaccination for solicited and
 unsolicited safety parameters. Serious adverse events (SAEs) will be collected throughout the
 study.
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.