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Sponsor: Sanofi Pasteur, a Sanofi Company
Conditions: Dengue Virus, Dengue Fever, Dengue Hemorrhagic Fever, Dengue Disease
Interventions: CYD dengue vaccine serotypes (1, 2, 3, 4)., Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide
Countries: Vietnam
This trial evaluated the use of a tetravalent vaccine against dengue. Primary objectives: * To describe the humoral immune response to dengue before and after each vaccination with tetravalent dengue vaccine in adults, adolescents, and children. * To evaluate the safety of each vaccination with tetravalent dengue vaccine in the 4 age cohorts. * To evaluate the persistence of antibodies against dengue during 5 years after the first vaccination with tetravalent dengue vaccine in the 4 age cohorts.
Sex: ALL
Age: 2 Years to 45 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria : * Aged 2 to 45 years on the day of inclusion. * Provision of Informed Consent/Assent Form signed by the participant (and/or by the parent or another legally acceptable representative for participants \<18 years). * Participant (and parent/guardian for participants \<18 years) 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 the first vaccination, until at least 4 weeks after the last vaccination. * Participant in good health, based on medical history, physical examination and laboratory parameters. 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 serum pregnancy test at Screening. * For a female participant of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of the first injection. * Breast-feeding female participant. * Receipt of any vaccine in the 4 weeks preceding the first trial vaccination. * Human immunodeficiency virus, hepatitis B, or hepatitis C seropositivity in the blood sample taken at screening. * Planned participation in another clinical trial during the first year of the study. * Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the past 6 months, 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. * 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 past 3 months that might interfere with the assessment of immune response. * Participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. * Laboratory abnormalities of at least moderate severity or clinically significant according to the Investigator 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 receipt of any vaccine in the 4 weeks following the first trial vaccination. * Familial atopy medical history (parents, brothers, or sisters). * Previous vaccination with meningococcal A+C or typhoid vaccines within 3 years prior to inclusion. * History of meningococcal or typhoid infections (confirmed either clinically, serologically or microbiologically).
- Long Xuyen, An Giang, Vietnam