Efficacy and Safety of Dengue Vaccine in Healthy Children

Inclusion Criteria :

• Aged 4 to 11 years on the day of inclusion.
• Subject in good health, based on medical history and physical examination.
• Provision of assent form signed by the subject (for subjects ≥ 7 years old) and informed consent form signed by the parent or another legally acceptable representative.
• Subject and parent/ legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures.
• Subject attending one of the schools involved in the trial and living in the Ratchaburi Province.
• For a female subject 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 subject 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.
• Subject 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
• Subject who plans to attend another school (outside the trial area) or move to another city in the coming 30 months.