EUCTR2014-005036-33-Outside-EU/EEA进行中（未招募）不适用
A phase I study to investigate safety and reactogenicity of Vaxem Hib in healthy children aged 16 – 20 months and infants aged 2 - 4 months. - Safety and Reactogenicity of a Monovalent Conjugated Vaccine Against HAEMOPHILUS INFLUENZAE TYPE b.
ovartis Vaccines and Diagnostics0 个研究点目标入组 40 人开始时间: 2014年11月18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
- 40
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) Infants of either sex, aged 16 - 20 months / 2 - 4 months;
- •2) in good health as determined by:
- •medical history
- •physical examination
- •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;
- •Informed consent must be obtained for all the subjects before enrollment into the study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •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 presented a previous disease potentially related to Haemophilus influenzae type b;
- •3) infants who had household contact and/or intimate exposure in the previous 30mdays to an individual with ascertained Haemophilus influenzae type b disease;
- •4) infants who have received any other Haemophilus influenzae type b immunizationmdose before (for 16-20 months old children who have received a booster vaccination already);
- •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) 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) treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives (or: within the past 3 months - applicable for children 16 - 20 months);
- •14) any vaccination administered within 2 weeks (14 days) before enrollment;
- •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
相似试验
进行中（未招募）
1 期
study to investigate the safety and clinical activity of APR-246 in combination with dabrafenib in patients with unresectable metastatic melanoma resistant to dabrafenib /trametinib combinatioEUCTR2017-002577-18-BEAPREA THERAPEUTICS AB50
撤回
1 期
A Phase I/Ib Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of DSM265 in Healthy Subjects and to Assess the Antimalarial Activity of DSM265 in Healthy Subjects with an Induced Blood Stage Plasmodium falciparum Infection.PART 3.Infection - Other infectious diseasesMalariaACTRN12613000533796CPR Pharma Services24
已完成
1 期
A Phase I/Ib Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of DSM265 in Healthy Subjects and to Assess the Antimalarial Activity of DSM265 in Healthy Subjects with an Induced Blood Stage Plasmodium falciparum Infection.PART 1.MalariaACTRN12613000522718CPR Pharma Services73
已完成
1 期
A Phase I/Ib Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of DSM265 in Healthy Subjects and to Assess the Antimalarial Activity of DSM265 in Healthy Subjects with an Induced Blood Stage Plasmodium falciparum Infection.PART 2.Infection - Other infectious diseasesMalariaACTRN12613000527763CPR Pharma Services10
终止
1 期
A Phase I/IIa Study of DVC1-0101 in Subjects with Intermittent Claudication or Critical Limb Ischaemia Secondary to Peripheral Artery DiseaseACTRN12615001144505CMAX - a division of IDT Australia3