CTRI/2023/10/058954已完成Unknown
An Open label, 1-arm study to investigate clinical safety, tolerability, acceptability and performance of IntegriMedical® Needle Free Injection System in administering booster Diphtheria-Tetanus-Pertussis (DTP) vaccine in healthy male and female pediatric subjects aged =5 to =6 years of age. - NFIS
IntegriMedical0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
入选标准
- •Patients meeting following inclusion criteria will be eligible for participation in the study
- •1 Parents/ Legally Acceptable Representative (LAR) of the subject willing to sign the informed consent form
- •2 Eligible and due for booster dose of DTP vaccine
- •3 Physical examination without clinically significant findings
- •4 No history of liver disorders in past 3 months
- •5 No history of kidney disorders in past 3 months
- •6 No history of cardiovascular disorders in past 3 months
- •7 No history of neurological disorders in past 3 months
- •8 In good general health without clinically significant medical history and based on clinical judgment of principal investigator
排除标准
- •Subjects are excluded from the study if any of the following criteria apply
- •Medical Conditions and Prior medication
- •1 Are malnourished, defined by weight less than two standard deviations below the median weight for their age
- •2 More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment
- •3 Blood products within 16 weeks prior to enrollment
- •4 Evidence of autoimmune disease or immunodeficiency
- •5 Asthma that is not well controlled
- •6 Idiopathic urticaria within the past year
- •7 Hypertension that is not well controlled
- •8 Malignancy that is active or history of malignancy
- •9 Have a genetic anomaly or known cytogenic disorder (e.g., Down syndrome)
- •10 Bleeding disorder history (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM, SC injection or blood draws
- •11 Diabetes mellitus (type I )
- •12 Any medical, psychiatric, social condition, or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteers ability to give informed consent
- •13 Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid- tetanus toxoid-, or pertussis-containing vaccine, or to any component of INFANRIX
- •14 Encephalopathy within 7 days of administration of a previous pertussis-containing vaccine
- •15 Progressive neurologic disorders
- •16 If Guillain-Barré syndrome occurs within 6 weeks of receipt of a prior vaccine containing tetanus toxoid
- •17 Syncope (fainting) occurred anytime in association with administration of injectable vaccines, including INFANRIX
- •18 If temperature =105°F, collapse or shock-like state, or persistent, inconsolable crying lasting =3 hours have occurred within 48 hours after receipt of a previous pertussis- containing vaccine, or if seizures have occurred within 3 days after receipt of a previous pertussis-containing vaccine
- •Prior/Concurrent Clinical Study Experience
- •19 Investigational research products within 4 weeks prior to enrollment or planning to receive investigational products while on the study
研究者
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