EUCTR2014-005246-22-Outside-EU/EEA进行中（未招募）不适用
A phase III, observer-blind, randomized, controlled, single center study to investigate immunogenicity and safety of VaxemTM Hib in 13 - 59 months old healthy children in China, according to the recommended regimen of 1 dose.
ovartis Vaccines and Diagnostics, S.r.l.0 个研究点目标入组 729 人开始时间: 2014年12月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 729
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. 13-59 months-old children;
- •2. in good health as determined by:
- •a. medical history
- •b. physical examination
- •c. clinical judgment of the investigator;
- •3. available for all visits scheduled in the study and able to comply with all study regulations;
- •4. written informed consent obtained, from at least one parent or legal guardian.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 729
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects presenting any of the following will not be included in the study:
- •1. parent or legal guardian is unwilling or unable to give written informed consent to participate in study;
- •2. children who have received any other Haemophilus influenzae type b immunization dose before;
- •3. children who presented a previous disease potentially related to Haemophilus influenzae type b;
- •4. children who had household contact and/or intimate exposure in the previous 30days to an individual with ascertained invasive Haemophilus influenzae type b disease;
- •5. premature (before 37th week of gestation) or birth weight less than 2500 g;
- •6. history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
- •7. fever >=38.0 °C (axillary) and/or significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment;
- •8. subjects with any serious chronic disease such as cardiac, neurological, metabolic, hematologic, or neoplastic disease;
- •9. known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder;
- •10. subjects with any neurological disorder, e.g. epilepsy or history of seizure disorder;
- •11. subjects with a clinically significant genetic anomaly;
- •12. treatment with corticosteroids or other immunosuppressive drugs;
- •13. any previous treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives;
- •14. any vaccination administered within one week (7 days) before enrollment and/ or any planned administration of any vaccine outside the Chinese routine vaccination program;
- •15. participation in any other investigational trial simultaneously;
- •16. planned surgery during the study period;
- •17. any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objective.
研究者
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