Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years
- Conditions
- -A90 Dengue fever [classical dengue]Dengue fever [classical dengue]A90
- Registration Number
- PER-031-08
- Lead Sponsor
- SANOFI PASTEUR S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Age from 2 to 11 years to the day of inclusion (Preselection)
• Subject with good health, according to medical history, physical examination and laboratory parameters (Preselection + VOl)
• Assent form signed by the subject (subjects> 8 years of age) and Informed Consent Form signed by the parents or other legal representative (and by an independent witness if the father or mother is illiterate) (Preselection)
• Possibility of the subject and the parents / legal representative to attend all the scheduled visits and to comply with all the study procedures (Preselection + VOI)
• For subjects able to conceive (girls who have already had their menarche), prevent pregnancy (use of effective contraception or abstinence) for at least 4 weeks before the first vaccination and at least 4 weeks after the last vaccination (Preselection + VOI).
• Documented application of the yellow fever vaccine at least one month before the first vaccination (Preselection)
• Personal or family history of thymus pathology (thymoma), thymectomy or myasthenia (Preselection).
• For subjects with capacity to conceive (girls who have already had their menarche), known pregnancy (Pre-selection)
• For subjects with the ability to conceive (girls who have already had their menarche), known pregnancy or positive pregnancy test in the sample of blood drawn in the preselection (VOI)
• Participation in another clinical study that investigates a vaccine, a medication, a medical device or a medical procedure in the 4 weeks prior to the first vaccination of the study (Preselection + VOI).
• Participation planned in another clinical study during the present study (Preselection).
• Congenital or acquired immunodeficiency known or suspected, immunosuppressive therapies such as anticancer chemotherapy or radiotherapy within the previous 6 months, or long-term systemic corticosteroid therapy (Preselection).
• Known systemic hypersensitivity to any of the components of the vaccines, or a history of life-threatening reactions to the study vaccines or to a vaccine containing the same substances (Preselection).
• Systemic hypersensitivity to the vaccine against yellow fever or a history of life-threatening reactions to the yellow fever vaccine (Preselection).
• Chronic disease in a stage that could interfere with the completion or completion of the study, in the opinion of the researcher (Preselection).
• Abuse of alcohol or addiction to drugs, current or past, that could interfere with the ability of the subject to comply with the procedures of the study (Preselection).
• Administration of blood or blood products in the last 3 months that may interfere with the evaluation of the immune response (Preselection).
• Administration of any vaccine in the 4 weeks prior to the first vaccination of the study (Pre-selection).
• Planned administration of any vaccine in the 4 weeks after the first vaccination of the study (Preselection + VOI).
• Seropositivity to human immunodeficiency virus, hepatitis B antigen or hepatitis C in the blood sample taken at the preselection (VOI).
• Clinically significant laboratory abnormalities (as determined by the investigator) in the blood sample drawn in the preselection (VOI).
• Knowledge of previous vaccination with the vaccine against pneumococcal polysaccharide (Preselection)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method