study of chimerivax™ tetravalent dengue vaccine in healthy peruvian children aged 2 to 11 years

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

Summary: 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).

participants were randomized to receive either three injections of cyd dengue vaccine or two injections of placebo, and one injection of a pneumococcal polysaccharide vaccine (pneumo23®) at 0, 6, and 12 months, respectively.

Eligibility criteria:
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.

Keywords: dengue virus dengue fever dengue hemorrhagic fever dengue diseases dengue vaccine