study of sanofi pasteur's cyd dengue vaccine in healthy subjects in singapore

Conditions: Dengue Fever; Dengue Hemorrhagic Fever; Dengue Virus; Dengue Diseases

Summary: primary objectives: * to evaluate safety after each cyd dengue vaccination in terms of injection site and systemic reactogenicity. * to evaluate the occurrence of serious adverse events (saes) throughout the trial period. * to evaluate the humoral immune response to each cyd dengue serotype after each vaccination in a subset of participants. secondary objectives: * to evaluate the persistence of the humoral immune response during 4 years after the last vaccination in a subset of participants.

this was a multicenter trial involving three vaccinations one each at 0, 6 and 12 months over a period of 1 year, and a 4-year follow-up following the last vaccination.

Eligibility criteria:
inclusion criteria : * aged from 2 to 45 years on the day of inclusion. * participant in good health, based on medical history and physical examination. * provision of informed consent form (and assent form for participants aged 6 to 12 years) signed by the participant and by the parent(s) or another legally acceptable representative for participants aged less than 21 years. * participants and parent(s)/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures. * for a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks before the first vaccination until 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 the first vaccination, according to investigator judgment. * for a woman of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of inclusion. * breast-feeding woman. * known systemic hypersensitivity to any of the components of the trial vaccines (especially egg proteins or neomycin) or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances. * personal or family history of thymic pathology or myasthenia. * previous hepatitis a vaccination (for children only). * 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 corticosteroid therapy. * 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 that might interfere with the assessment of immune response. * 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 18 coming months. * 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. * participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. * current or past alcohol abuse or drug addiction that may interfere with the participants ability to comply with trial procedures. * participant who plans to move to another country within the 18 coming months.

Keywords: dengue virus dengue fever dengue hemorrhagic fever dengue diseases sanofi pasteur's cyd dengue vaccine