IRCT20201214049709N5招募中1 期
Safety and Immunogenicity of Razi Cov-2 recombinant Spike protein vaccine (RAZI Cov Pars) in healthy children and adolescents aged 5-17 years; single group, open label study
Razi Vaccine and Serum Research Institute0 个研究点目标入组 420 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 420
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
- 5 years 至 17 years（—）
- 性别
- All
入选标准
- •Participants legal guardian should be able to read and write
- •Age between 5-17 years
- •Having good health based on clinical and laboratory criteria
- •Negative RT-PCR test for COVID-19
- •Signed the informed consent form
- •Not pregnant
- •Negative beta HCG pregnancy test on screening and vaccination day
- •Use of at least one effective method of contraception (condoms, oral contraceptive pills, intrauterine device, Norplant capsule) and willing to continue using it in female couples
排除标准
- •Any ongoing, symptomatic acute or chronic illness requiring continuous medical or surgical care on the day of vaccination
- •Breastfeeding
- •Received any Covid Vaccine
- •Received any vaccine during the 14-days period prior to the screening day
- •Received blood and/or any blood products and/or immunoglobulins within three months preceding the screening day
- •History of long-term use of immunosuppressive medication (defined as more than 14 consecutive days) in the last 6 months leading up to screening day
- •Long-term use (defined as more than 14 consecutive days) of systemic corticosteroids within the past 6 months leading up to screening day
- •History of severe allergic diseases (such as Dyspnea, angioedema, anaphylactic reactions, urticaria and eczema)
- •History of allergy to any drug or vaccine (defined as any clinical signs or symptom of itching at the injection site, urticaria in the body after injection, excessive redness at the injection site)
- •History of immunological disorder (congenital or acquired)
- •History of chemotherapy in the last 5 years
- •History of cancer in the last 5 years
- •History of acute and serious psychiatric illnesses
- •History of blood disorders (dyscrasia, coagulopathy, platelet deficiency or disorder, deficiency of blood factors)
- •Severe acute or chronic renal or hepatic failure based on laboratory parameters
- •Suffering from chronic obstructive pulmonary disease such as asthma, or severe renal/hepatic diseases requiring continuous treatment by a specialist
- •Uncontrolled hypertension
- •Uncontrolled Diabetes
- •History of chronic neurological diseases (including seizures and epilepsy)
- •Any history of substance or alcohol abuse
- •Grade 1 or higher abnormal laboratory (hematology or biochemistry) tests based on toxicity score on the screening day
- •History of confirmed COVID-19 diseases during the 6-months period before the screening day (positive PCR test or clinical diagnosis)
- •Acute febrile illness at the time of vaccination
- •History of allergy to acetaminophen
- •Receiving prophylactic drug against tuberculosis
- •History of faint when see blood
- •Splenectomy for any reason
- •Any close contact with a confirmed COVID-19 case within two weeks before the first dose of vaccine
- •Congenital disorders, developmental disorders, severe malnutrition or genetic diseases
- •Participating in any clinical trials (research) other than this study
研究者
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