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Sponsor: Sanofi Pasteur, a Sanofi Company
Conditions: Dengue Virus, Dengue Fever, Dengue Hemorrhagic Fever, Dengue Diseases
Interventions: CYD Dengue Vaccine Serotypes 1, 2, 3, and 4, Pneumococcal polysaccharide vaccine
Countries: Peru
The aim of the trial was to evaluate the use of a tetravalent vaccine, CYD dengue vaccine, against dengue disease. Primary Objectives: * To describe the humoral immune response to dengue before and after each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years) previously vaccinated with yellow fever (YF) vaccine. * To evaluate the safety of each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years). * To describe viremia after the first and second vaccinations with dengue vaccine in a subgroup of 130 randomized participants (100 participants in Dengue Vaccine Group and 30 participants in Control Group) in two age cohorts of children (6 to 11 years and 2 to 5 years).
Sex: ALL
Age: 2 Years to 11 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria : * Aged 2 to 11 years on the day of inclusion. * Participant in good health, based on medical history, physical examination and laboratory parameters. * Provision of Assent Form signed by the participants (for participants \>=8 years old) and Informed Consent Form signed by the parents or another legally acceptable representative (and by an independent witness for illiterate parent\[s\]). * Participant and parents/legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures. * 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. * Documented receipt of yellow fever vaccine since at least one month before the first vaccination. Exclusion Criteria : * Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia. * For a female participant of child-bearing potential (girls post-menarche), known pregnancy. * For a female participant of child-bearing potential (girls post-menarche), known pregnancy or positive pregnancy test in blood sample taken at Screening. * Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination. * Planned participation in another clinical trial during the trial. * 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 vaccines components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances. * Systemic hypersensitivity to YF vaccine or history of a life-threatening reaction to YF vaccine. * Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator. * Current or past alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures. * Receipt of any blood or blood-derived products in the past 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. * Human Immunodeficiency Virus, hepatitis B antigen, or hepatitis C seropositivity in blood sample taken at Screening. * Clinically significant laboratory abnormalities (as determined by the Investigator) in blood sample taken at Screening. * Known previous vaccination with pneumococcal polysaccharide vaccine.
- Chulucanas Morropon, Piura, Peru