A Study of Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines

Exclusion Criteria

• •Family members from the Investigator or from the staff involved in the trial
• •Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
• •Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• •History of central nervous system disorder or disease, including seizures
• •History of varicella, measles, mumps, rubella and hepatitis A; confirmed either clinically, serologically, or microbiologically
• •Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion
• •Previous vaccination against measles-mumps-rubella, hepatitis A or varicella
• •Previous vaccination against flavivirus diseases
• •Known systemic hypersensitivity to any of the components of the vaccines, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
• •Planned participation in another clinical trial during the present trial period
• •Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
• •Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
• •Planned receipt of any vaccine in the 4 weeks following the first trial vaccination
• •Human immunodeficiency virus (HIV) seropositivity in the blood sample taken at screening
• •Clinically significant laboratory abnormalities, as judged by the Investigator, in blood sample taken at screening
• •Temporary exclusions: vaccination postponed until the condition is resolved:
• •Febrile illness (temperature ≥ 38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
• •Receipt of oral or injected antibiotic therapy within 72 hours prior to the vaccination visit
• •Any vaccination received in the 4 weeks preceding vaccination