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Sponsor: Sanofi Pasteur, a Sanofi Company
Conditions: Dengue, Dengue Hemorrhagic Fever
Interventions: Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus, NaCl 0.9%, Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed, Meningococcal A+C vaccine
Countries: Brazil
The purpose of this study is to generate immunogenicity and safety data in preparation for efficacy studies in Latin America. Primary Objectives: * To describe the immune response to dengue viruses before and after each vaccination with CYD dengue vaccine. * To evaluate the safety of each vaccination with CYD dengue vaccine.
Sex: ALL
Age: 9 Years to 16 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria : * Aged 9 to 16 years on the day of inclusion * Participant in good health, based on medical history and physical examination * Provision of assent form/informed consent form signed by the participant and by the parent(s) or another legally acceptable representative * Participant and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and to comply with all trial procedures * For a female participant 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 participant 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 participant'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 * Participant deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized without his/her consent * Febrile illness (temperature ≥ 38.0 ºC) 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.
- Vitória, Brazil