PER-031-08已完成未知
Immunogenicity and Safety of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years Previously Vaccinated Against Yellow Fever in Peru
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •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)
排除标准
- •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)
研究者
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