RBR-9nn3scw尚未招募4 期
Phase 4, randomized, controlled, single-blind study to assess the immunogenicity and safety of a third dose of heterologous booster with recombinant covid-19 vaccine (AstraZeneca/Fiocruz), covid-19 mRNA vaccine (Pfizer/Wyeth) or vaccine recombinant covid-19 (Janssen) in subjects previously vaccinated against Covid-19 with two doses of Sinovac/Butantan compared to a third homologous booster dose of adsorbed inactivated covid-19 vaccine (Sinovac/Butantan) in adults
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
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
- 0 至 0（—）
入选标准
- •Male or female =18 years of age; Subjects are willing and able to comply with the study procedures; Individuals are willing and able to provide informed consent prior to screening; Subjects who received two doses of Sinovac/Butantan vaccine, 182 days (±30 days) prior to inclusion in this study; Female participants are eligible to participate in the study if they are not pregnant, have recently given birth or are breastfeeding
排除标准
- •Subjects with fever >37.5 °C (axillary) or any acute illness at baseline (Day 1) or within 3 days prior to randomization; Individuals with a history of COVID-19; Subjects with a history of severe adverse reaction associated with a vaccine or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines as described in the latest summary of product characteristics for Sinovac/Butantan, Fiocruz/AstraZeneca, Pfizer/Wyeth, Janssen; Individuals with a known bleeding disorder that, in the investigator's opinion, would contraindicate intramuscular injection; Individuals with any severe or progressive neurological disorder, seizure disorder, or a history of Guillian-Barré syndrome; Subjects who received treatment with immunosuppressive therapy in the last 15 days, including cytotoxic agents or systemic corticosteroids, or planned receipt during the study period; Individuals with autoimmune diseases, with the exception of: Hashimoto's thyroiditis, vitiligo, psoriasis, lupus discordes and the like, HIV positive individuals and/or being treated for HIV; Individuals who received any other investigational product within the 30 days prior to Day 1 or intend to participate in another clinical study at any time during the course of this study; Subjects who received any other licensed vaccine within 14 days of enrollment in this study or who plan to receive any vaccine within 28 days of vaccination; Subjects who received 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 of inclusion or planned administration during the study period; Individuals with any condition that, in the investigator's opinion, could interfere with the primary objectives of the study or represent additional risk to the participant; Any other Covid-19 vaccine with the exception of two doses of CoronaVac.
研究者
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