study of cyd dengue vaccine in healthy children and adolescents in south america

Conditions: Dengue; Dengue Hemorrhagic Fever

Summary: 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.

participants in the dengue vaccine group will receive 3 vaccinations with cyd dengue vaccine. participants in the control group will receive placebo vaccinations for the first 2 vaccinations, followed by tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (adacel®) (in venezuela) or meningococcal a+c vaccine (in brazil) as a way of providing therapeutic benefit to the participants in the control group.

Eligibility criteria:
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.

Keywords: dengue dengue hemorrhagic fever cyd dengue vaccines