IRCT20201214049709N6已完成未知
Immunogenicity and Safety of intranasal Razi Cov Pars as a booster dose in adult population; randomised, double blind, placebo controlled clinical trial
Razi Vaccine and Serum Research Institute0 个研究点目标入组 206 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 206
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 or in the case of foreign nationals with a legal residence permit
- •Age 18 years and older
- •History of full vaccination with one of the following vaccines: Sinopharm, Razi Cov Pars, Pastocovac, Spikogen, AstraZeneca, Fakhra, or Barkat at least 5 months before the study
- •5 months interval between the last vaccine dose and the current study participation
- •In the last six months, the person has not had a confirmed Covid-19 disease based on laboratory evidence or confirmed by a physician
- •Signing a written informed consent form
- •Using at least one reliable contraceptive method (condom, oral contraceptive pills, intrauterine contraceptive device, IUD, Norplant capsule) for women of reproductive age 18 to 49 years until 3 months after receiving the booster dose
- •Negative pregnancy test (baby check) on the day of vaccination
排除标准
- •History of allergic reactions after receiving any previous Covid-19 vaccines or any other drug or vaccine
- •Having any acute or chronic illness requiring continuous ongoing medical or surgical care within the last months
- •History of severe cardiovascular disease such as heart failure, or hospitalization due to heart disease within the last year
- •Pregnancy declared by the participant based on the first day of the last menstrual period (LMP)
- •Breastfeeding
- •History of receiving any vaccine within 14 days of receiving the intranasal booster dose
- •Received blood and/or any blood products and/or immunoglobulins within three months prior to the intranasal booster dose
- •Diagnosed (suspected or confirmed) with immunocompromising illneses, 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 for more than 14 consecutive days with the exception of topical steroids within the last 4 months
- •Recent diagnosis or treatment of cancers except basal cell carcinoma and In-situ cervical cancer
- •History of uncontrolled serious psychiatric illnesses
- •History of blood disorders (dyscrasia, coagulopathy, platelet deficiency or disorder, or deficiency of blood clotting factors)
- •History of chronic neurological diseases (including seizures and epilepsy)
- •Current substance or alcohol abuse
- •Acute febrile illness at the time of receiving the booster dose
- •Splenectomy for any reason
- •Close contact with a confirmed COVID-19 case within two weeks before participating in the current study
- •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 as prophylaxis is allowed
- •Chronic unstable diseases in the last 4 weeks, including hospitalization due to surgery, deterioration of one of the organ system's function, a need to add new drugs or serious dose adjustments for existing drugs
研究者
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