IRCT20150303021315N24招募中3 期
A phase III, Randomized, Two-armed, Double-blind, Placebo controlled trial to evaluate efficacy and safety of an adjuvanted recombinant SARS-CoV-2 spike (S) protein subunit vaccine (SpikoGen®) produced by CinnaGen Co. (Two doses of 25µg with dosing interval of 21 days)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 16,876
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 50 years（—）
- 性别
- All
入选标准
- •Men or women 50 > age = 18
- •Participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations and tests
- •Healthy adults or adults with stable medical conditions
- •Women eligible to participate in the study who are not pregnant or breastfeeding
排除标准
- •Subjects with active infection with SARS-COV-2 signs at the screening visit
- •Subjects with body temperature equal or more than 38 degrees centigrade, during 72 hours before screening visit or during the visit
- •Subjects with any progressive or severe neurological disorder, including dementia, stroke, seizures, or a history of Guillain-Barre syndrome
- •High-risk subjects who are prioritized for the national vaccination program, those are treated with immunosuppressive drugs or cytotoxic drugs, or systemic corticosteroids at doses = 10 mg daily of prednisolone or equivalent doses of other corticosteroids more than 14 days
- •Pregnant women, or breastfeeding mothers, or women who plan to become pregnant during the study
- •Subjects who have a history of severe allergic reactions (e.g. anaphylaxis) to the study vaccine or any components of the vaccine or any other drugs
- •Subjects who have received any other investigational product within 30 days prior to the screening visit or intend to participate in other clinical studies during this trial
- •Subjects who have been vaccinated with other vaccines against the SARS-CoV-2 virus
- •Subjects who received other authorized vaccines within 28 days prior to the screening visit in this study or intend to receive any vaccines up to 14 days after the second vaccination
- •Subjects who have any known bleeding disorder or may have problems with the intramuscular injection according to the researcher's opinion
- •Subjects who have received or intend to receive any blood / plasma or immunoglobulin products 90 days prior to the screening visit
- •Subjects with special circumstances who, may increase the risk of participating in the study or interfering with the evaluation of the primary endpoints of the study according to researcher's opinion
- •Subjects who have donated =450 ml of blood or blood products 28 days prior to the screening visit
- •Subjects who are given the priority of vaccination within 2 months after participating in the study, according to the national immunization program
- •Subjects with ESRD
- •Subjects with dawn syndrome
- •Subjects with BMI = 40
- •Subjects with cystic fibrosis, COPD, PAH
- •Subjects with uncontrolled asthma
- •Subjects with uncontrolled hypertension
- •Subjects with uncontrolled diabetes Mellitus
研究者
相似试验
招募中
3 期
Evaluating the efficacy and safety of Ocrelizumab (CinnaGen, Iran) in comparison to Ocrevus® (Roche, Switzerland) in patients with relapsing multiple sclerosisRelapsing Multiple Sclerosis (RMS).Multiple sclerosis (of):NOSbrain stemcorddisseminatedgeneralizedIRCT20150303021315N13CinnaGen company170
进行中（未招募）
不适用
Efficacy and Safety study comparing PRAVAFENIX (combination of fenofibrate and pravastatin) versus Atoravastatin in high coronary heart disease risk patients with mixed dyslipidaemiamixed dyslipidaemiaMedDRA version: 16.0Level: PTClassification code 10058108Term: DyslipidaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 16.0Level: PTClassification code 10070901Term: Diabetic dyslipidaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 16.0Level: PTClassification code 10007649Term: Cardiovascular disorderSystem Organ Class: 10007541 - Cardiac disordersEUCTR2012-000575-17-BGaboratoires SMB S.A.430
进行中（未招募）
不适用
Efficacy and safety study comparing PRAVAFENIX versus atorvastatin 20 mg in high coronary heart disease risk patients with mixed dyslipidaemiaEUCTR2012-000575-17-HRABORATOIRES SMB S.A.430
进行中（未招募）
不适用
Efficacy and safety study comparing PRAVAFENIX versus atorvastatin 20 mg in high coronary heart disease risk patients with mixed dyslipidaemiaEUCTR2012-000575-17-LVABORATOIRES SMB S.A.430
已完成
3 期
Evaluation of efficacy and safety of Denosumab (produced by AryoGen Pharmed Co.) versus Denosumab (Xgeva®, produced by Amgen Co.)IRCT20150303021315N21AryoGen Pharmed Co.272