IRCT20171122037571N4已完成3 期
A Clinical trial to evaluate the immunogenicity and safety of Omicron-Based CovIran Barkat vaccine as a third injection dose in vaccinated population over 18 years of age
SHIFAPHARMED Industrial Group Co0 个研究点目标入组 210 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
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
- •Aged over 18 years old
- •In the volunteer’s vaccination history, the interval between the first and second dose is between 4 to 8 weeks and at least 3 months and at most 5 months have passed since the injection of the second dose of the volunteer's vaccination.
- •The volunteer must be able and willing to cooperate with the researchers throughout the study period.
- •The volunteer must be able to fully understand the executive processes of the study and to understand the explanations of the facilitators correctly.
- •The volunteer would be able to understand the contents of the informed consent form and sign the informed consent before recruitment.
- •Access to the medical records and test results if hospitalised for any reason including due to the suspected or confirmed COVID-19 should be allowed.
- •The volunteer has been in a medically stable condition for the past three months (he/she has not been hospitalized, his / her chronic illness has not recurred). His / her chronic illness medication instructions have not changed due to lack of control over clinical symptoms, etc.)
排除标准
- •Confirmed, suspected, or asymptomatic COVID-19 case
- •Candidate with a history of SARS-CoV-2 infection (documented rtPCR) after receiving the second dose of COVID-19 vaccine.
- •During the period of home quarantine due to Covid-19 (suspicion of exposure or suspicious symptoms).
- •In the 14 days prior to vaccination: fever or presence of at least two symptoms from Dry cough, severe fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhoea, dyspnea, and shortness of breath
- •History of severe allergic reaction, urticaria or allergic reactions to COVID-19 Inactivated vaccine ingredients (allergic to Aluminium).
- •Personal or family history of seizure, epilepsy, encephalopathy or psychiatric disorders
- •Presence of congenital malformations or any genetic disorder
- •Presence of any malignancy
- •Known case of immunodeficiency, HIV, lymphoma, leukemia, or other autoimmune diseases.
- •Receiving immunosuppressive drugs or corticosteroids in the last 6 months
- •Splenectomy or history of any organ removal
- •History of coagulation disorders
- •History of hereditary and acquired angioedema over the past year
- •Receiving Anti-TB treatment
- •Positive HBsAg/ Positive HCV antibody
- •Receiving immunomodulators or immunosuppressors at least for14 days in the past 3 months
- •Receiving live vaccine in one month or other vaccines in 14 days before inoculation
- •Receiving immunoglobulins or blood products in 3 months before inoculation
- •History of severe mental disorders affecting the participation in the study
- •Women with a positive pregnancy test (Beta HCG in a blood sample) or breastfeeding or those who intend to become pregnant during the study period.
- •Any other circumstances are other than the above-mentioned ones that the researcher deems inappropriate for a person participating in a clinical trial. These cases are recorded as the reason for not entering.
研究者
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