IRCT20201214049709N4招募中未知
Comparison of immunogenicity and safety of Razi Cov Pars and Sinopharm booster doses in adults 18 years of age and older who have primarily vaccinated with Sinopharm: a ?parallel ??2?? arms, ?randomised, double blind clinical trial ?
Razi Vaccine and Serum Research Institute0 个研究点目标入组 500 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 500
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
- 18 years 至 no limit（—）
- 性别
- All
入选标准
- •Having Iranian citizenship;
- •Age 18 years and older;
- •Having history of full vaccination with Sinopharm vaccine (two doses) 75 to 195 days from the last vaccination;
- •Signing an informed consent form;
- •For females of childbearing age 18 to 49 years: use of at least one effective method of contraception (condom, oral contraceptive pills, intrauterine device, norplant capsule) and willing to continue up to two month after the booster dose.
排除标准
- •History of allergy to drugs or vaccines (e.g urticaria and fever);
- •Any current or new diagnosis of acute or chronic illness requiring continuous ongoing medical care;
- •Severe cardiovascular disease;
- •Breastfeeding;
- •History of receiving any vaccine within 14 days before receiving the booster dose;
- •History of diseases resulting in immunosuppression (suspected and definite);
- •History of long-term use of immunosuppressive drugs, including history of long-term use of systemic corticosteroids (equivalent to 10 mg or more daily prednisolone) with the exception of topical steroids (more than 14 consecutive days) within the past 4 months;
- •History of uncontrolled serious psychiatric illnesses;
- •History of chronic neurological diseases (including seizures and epilepsy)?
- •Acute febrile illness at the time of booster vaccine injection;
- •Splenectomy for any reason;
- •Close contact with a confirmed COVID-19 case within two weeks before the booster dose;
- •Continued use of anticoagulants such as coumarin and related anticoagulants (such as warfarin) or new oral anticoagulants / antiplatelet agents. Note: Less than 325 mg of aspirin per day is allowed as prophylaxis;
- •Recent diagnosis or treatment of cancers except basal cell carcinoma and In-situ cervical cancer;
- •Received blood and/or any blood products and/or immunoglobulins within three months preceding the booster dose;
- •History of blood disorders (dyscrasia, coagulopathy, platelet deficiency or disorder, or deficiency of blood clotting factors);
- •Current substance or alcohol abuse;
- •Pregnancy based on the participant's statement and the time of the first day of the last menstrual period and negative pregnancy test (baby check) on the day of vaccination;
- •History of COVID -19 based on laboratory or clinical evidence after primary vaccination;
- •Chronic unstable diseases in the last 4 weeks, including hospitalization due to surgery, deterioration of one organ function, the need to add new drugs or serious dose adjustments to existing drugs.
研究者
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