RBR-4vmh6xg招募中4 期
A phase 4, single blind, randomised controlled trial to assess the immunogenicity, safety and reactogenicity of a third heterologous full or fractional booster dose Covid-19 vaccine in previously vaccinated adults
Centro de Estudos e Pesquisas em Moléstias Infecciosas LTDA - CePCLI0 个研究点开始时间: 2022年6月14日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 18Y 至 0（—）
入选标准
- •Males or females aged 18 years old or above; participants willing and able to comply with the study procedure; participants willing and able to provide informed consent prior to screening; participants who received two SinovacButantan vaccine doses at least 4 months, 120 days, prior to enrolment in this study, with a dose interval between each SinovacButantan dose of 14 to 35 days; for females of childbearing potential, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day) of screening and vaccination
排除标准
- •Participants with fever more than 37.5 oC (axillary) or any acute disease at baseline (Day 1) or within the 3 days prior to randomization, febrile participants with mild diseases may be enrolled at the investigator’s discretion; participants with a recent history of COVID-19 (less or equal to 4 weeks prior to visit 1), laboratory confirmed; participants with a history of serious vaccine-related adverse reaction or serious allergic reaction (e.g., anaphylaxis) to any study vaccine component, as described in the last summary of product characteristics for Sinovac/Butantan, AstraZeneca/Fiocruz or Pfizer/Wyeth; participants with a known bleeding disorder that, in the investigator’s opinion, would contraindicate intramuscular injection; participants with any progressive or serious neurological disorder, seizure disorder or history of Guillian-Barré syndrome; participants given treatment with immunosuppressant therapy within the last 90 days, including cytotoxic agents or systemic corticosteroids or planned receipt during the study period, if a short-term cycle of immunosuppressant systemic corticosteroid dose has been used to treat acute disease, the participant should not be enrolled in the study until corticosteroid therapy has been discontinued for at least 15 days prior to the first study vaccination, in case the participant has been on an immunosuppressant dose of a depot, intramuscular or intra-articular corticosteroid, 60 days should be waited for their enrolment in the study. Inhaled/nebulized, intra-articular, intrabursal or topical (skin or eyes) corticosteroids are allowed; participants with autoimmune diseases, other than: Hashimoto thyroiditis, vitiligo, psoriasis, discoid lupus and the like; HIV-positive participants and/or in treatment for HIV; participants given any other investigational product within the 30 days prior to Day 1 or who intend to take part in another clinical trial at any time during this study conduction; participants given any other licensed vaccine within 14 days prior to enrolment in this study or who plan to receive any vaccine up to 28 days after vaccination; participants given treatment with Rituximab or any other anti-CD20 monoclonal antibody within 9 months prior to Day 1 or planned during the study period; administration of intravenous immunoglobulins and/or any blood products within 3 months prior to enrolment or planned dosing during the study period; participants with any condition that, in the investigator’s opinion, could interfere with the status primary objectives or represent an additional risk for the participant; participants who have received any other vaccine for Covid-19 other than two Sinovac/Butantan doses
研究者
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