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Sponsor: Sanofi Pasteur, a Sanofi Company
Conditions: Dengue Virus, Dengue Fever, Dengue Hemorrhagic Fever, Dengue Diseases
Interventions: CYD Dengue Vaccine, Inactivated rabies virus vaccine, Placebo
Countries: Thailand
The primary objective of the study was to assess the efficacy of CYD dengue vaccine after three injections in preventing symptomatic virologically-confirmed dengue (VCD) cases, regardless of the severity, due to any of the four serotypes in children aged 4 to 11 years at the time of inclusion. Secondary objectives included to assess: * Vaccine efficacy against severe VCD cases * Vaccine efficacy against VCD cases following at least two injections with CYD dengue vaccine * Immune response to CYD dengue vaccine * Safety profile of CYD dengue vaccine. Safety assessments include solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period. Other objectives included: * Vaccine efficacy against VCD cases following at least one injection with CYD dengue vaccine * Vaccine efficacy against VCD cases due to each serotype * Participants with clinical signs and symptoms for VCD
Sex: ALL
Age: 4 Years to 11 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria : * Aged 4 to 11 years on the day of inclusion. * Participant in good health, based on medical history and physical examination. * Provision of assent form signed by the participants (for participants \>= 7 years old) and informed consent form signed by the parent or another legally acceptable representative. * Participant and parent/ legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures. * Participant attended one of the schools involved in the trial and living in the Ratchaburi Province. * For a female participant of child-bearing potential (girls post-menarche), 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 : * Febrile illness (temperature \>= 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment. * For a female participant of child-bearing potential (girls post-menarche), known pregnancy or positive urine pregnancy test on the day of the first trial vaccination. * Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia. * 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, or long-term systemic corticosteroids therapy. * Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to 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. * Receipt of blood or blood-derived products in the past 3 months. * Participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. * Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination. * 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.e * Participant who plans to attend another school (outside the trial area) or move to another city in the coming 30 months.
- Bangkok, Thailand