A Global, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Trial to Evaluate the Protective Efficacy and Safety of Influenza Virus Vector Covid-19 Vaccine for Intranasal spray (DelNS1-2019-nCoV-RBD-OPT1) in Adults Aged 18 Years and Older.

Beijing Wantai Biological Pharmacy Enterprise Co Ltd.0 个研究点目标入组 5,400 人开始时间: 2021年9月30日最近更新: 2023年5月29日

试验速览

阶段: 3 期
状态: 尚未招募
发起方
入组人数: 5,400

研究概览入排标准研究者记录与标识符相似试验

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: 19 Year(s) 至 44 Year(s)（—）
性别: All

入选标准

•1) Aged =18 years old at the time of enrollment;
•2)Be able to comply with the requirements of clinical study protocol and complete all trial procedures, and sign informed consent form;
•3)Subjects who have not received any COVID-19 vaccine(marketed or investigational), those who have received at least one dose of other COVID-19 vaccines (marketed or investigational) with an interval of =6 months between the last dose and the date when the subjects sign the informed consent for this study; 4)Those who are negative for HIV screening (depending on the relevant policy of the country where the trial is conduct, if qualification for HIV testing is required in the country, this information will be obtained mainly by inquiry while protecting the candidate’s privacy)
•5)Fertile males and females of childbearing potential who are willing to take appropriate contraceptive measures from signing ICF to 3 months after the last dose, including abstinence or effective contraceptive measures (e.g., intrauterine or implantable contraceptive devices, oral contraception, combination of contraceptive diaphragm or condom with contraceptive gel); women of childbearing potential should be negative for pregnancy test on the day of vaccination.
•6)Healthy people or people with a mild underlying disease that has remained stable without exacerbation (not requiring hospitalization or without major modification of the treatment regimen) within at least 3 months prior to inclusion in the study

排除标准

•Prior history of COVID-19;2)Positive test of total SARS-CoV-2 specific antibody using colloidal gold reagent[Only applicable to subjects without vaccination history of COVID-19 vaccine(marketedor investigational)];3)Pregnant or lactating women;4)Fever on the day of vaccination or within 3 days prior to vaccination (oral temperature =37.5°C/axillary temperature =37.3°C);5)Those who had any acute disease in the past 5 days that requires systemic antibiotic or antiviral treatment (including but not limited to the use of anti-influenza virus drugs such as Tamiflu, Relenza, Symmetrel or Flumadine);6)Those who had low immune function caused by immunodeficiency diseases, diseases of important organs,cancer, and immune diseases (e.g. Guillain Barre syndrome, systemic lupus erythematosus, rheumatoid arthritis, alienia or splenectomy caused by any condition, and other immune disease that may affect immune response at the investigator’s discretion);7)Long-term use (defined as =14 days) of immunosuppressants or other immunomodulators (for glucocorticoids, e.g., =10 mg/day prednisone or equivalent dose; inhaled and topical steroids are allowed) within 6 months prior to the first vaccination;8)History of hemorrhagic diseases (e.g., factor deficiency, thrombocytopenia or other coagulation disorders), or hemorrhagic tendency, or continuous requirement of anticoagulants;9)Having received immunoglobulins and/or blood products within 3 months before receiving the investigational vaccine;10)Received subunit or inactivated vaccine within 14 days before vaccination, or received live attenuated vaccine within 28 days before vaccination;11)Participation in a clinical trial of another product within 1 month prior to vaccination, or planning to participate in a clinical trial of another product during the study;
•A phase III clinical trial of influenza virus vector COVID-19 vaccine for intranasal spray (DelNS1-2019-nCoV-RBD-OPT1) Protocol No.: COVID-19-PRO-003Version No/Date: 2.0/ August 10, 2021Confidential3612)Having a history of severe allergic reactions or severe adverse reactions from previous immunizations, or allergy to any component of the investigational vaccine;13)Patients deemed by the investigator as unsuitable for using nasal spray (those with severe rhinitis or nasal deformities, etc.);14)Planning to relocate permanently from the current area prior to the completion of the study or to leave the current area for a long period (preventing compliance with the prescribed visit schedule) during the study visits;15)Other conditions that the investigators consider unsuitable for this clinical study.

研究者

发起方

Beijing Wantai Biological Pharmacy Enterprise Co Ltd.

相似试验

尚未招募

3 期

A Global, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Adults Aged 18 Years and Oldersevere acute respiratory syndrome coronavirus 2 SARS CoV 2

PACTR202107562417077ivzon Mabpharm Inc22,500

进行中（未招募）

不适用

A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-894 versus Placebo in Subjects with Diabetic Neuropathic Paidiabetic neuropathic painMedDRA version: 9.1Level: LLTClassification code 10054095Term: Neuropathic pain

EUCTR2007-001140-47-CZAbbott GmbH & Co. KG110

进行中（未招募）

1 期

EUCTR2007-001140-47-FRAbbott GmbH & Co. KG110

进行中（未招募）

1 期

A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-894, Duloxetine and Placebo in Subjects with Diabetic Neuropathic Paidiabetic neuropathic painMedDRA version: 9.1Level: LLTClassification code 10054095Term: Neuropathic pain

EUCTR2007-001139-71-FRAbbott GmbH & Co. KG275

进行中（未招募）

不适用

A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-894 versus Placebo in Subjects with Diabetic Neuropathic Pai

EUCTR2007-001140-47-GBAbbott GmbH & Co. KG110