EUCTR2014-005159-24-Outside-EU/EEA进行中（未招募）不适用
A Phase III, observer-blind, randomized, controlled, multi-center study to inventigate the immunogenicity and safety of the Vaxem Hib™ in 2-4 months old healthy infants in China, according to the recommended regimen of 3 intramascular doses given one month apart.
ovartis Vaccines and Diagnostics0 个研究点目标入组 916 人开始时间: 2014年12月23日最近更新:
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
- 916
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
- •Infants of either sex, aged 2 - 4 months in good health as determined by:
- •1. Medical history
- •2. Physical examination
- •3. Clinical judgment of the investigator;
- •4. Available for all visits scheduled in the study and able to comply with all study regulations
- •5. For whom written informed consent has been obtained from at least one parent or legal guardian
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 916
- •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
- •1. Parent or legal guardian is unwilling or unable to give written informed consent to participate in study
- •2. Infants who have received any other Haemophilus influenzae type b immunization dose before
- •3. Infants who presented a previous disease potentially related to Haemophilus influenzae type b
- •4. Infants who had household contact and/or intimate exposure in the previous 30 days to an individual with ascertained 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 body temperature) or/and 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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