[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Changchun BCHT Biotechnology Co.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":167},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,64,87,114,140],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100630794","phase-1-a-phase-i-clinical-trial-of-absorbed-acellular-pertussis-two-component-diphtheria-tetanus-combined-vaccine-for-adults-and-adolescents-100630794",false,"NCT07492303","A Phase I Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)","A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Different Doses of Adsorbed Acellular Pertussis (Two-component) Diphtheria-tetanus Combined Vaccine (for Adults and Adolescents) in People Aged 10 Years and Older in a Randomized, Blinded, Placebo-controlled Manner","Inclusion Criteria:\n\n* People aged 10 years or older;\n* Study participants and\u002For their guardians\u002Fauthorized representatives are willing to provide valid identity certification documents of the study participants and\u002For their guardians\u002Fauthorized representatives;\n* Informed consent of the study participants themselves and\u002For their guardians\u002Fauthorized representatives shall be obtained, and informed consent forms shall be signed;\n* Study participants themselves and\u002For their guardians\u002Fauthorized representatives are able and willing to comply with the requirements of the clinical trial protocol and complete all trial follow-up visits;\n* Study participants aged 10 to 11 years have not received any vaccine containing any component of Diphtheria, Tetanus and Pertussis within 3 years; - study participants aged 12 years or older have not received any vaccine containing any component of Diphtheria, Tetanus and Pertussis within 5 years;\n* Women of childbearing potential have used effective contraceptive measures within 2 weeks prior to enrollment in this trial, have a negative urine pregnancy test before administration of the investigational vaccine (pregnancy test may be waived for non-childbearing potential women), and voluntarily agree to use effective contraceptive measures within 6 months after vaccination; male study participants must agree to use effective contraceptive methods with their female partners within 6 months after vaccination.\n\nExclusion Criteria:\n\n* Axillary body temperature \\>37.0°C on the day of enrollment of trial participants;\n* Female trial participants who are breastfeeding or pregnant, or trial participants or their partners who plan to conceive within 6 months;\n* Persons with severe cardiovascular diseases, uncontrolled hypertension (e.g., systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg for trial participants aged 18-59 years before enrollment, or systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg for trial participants aged 60 years and above) or other severe chronic diseases (for persons aged 18 years and above);\n* Persons with clinically significant abnormal results of pre-vaccination tests of blood routine, blood biochemistry, urine routine, and coagulation function indicators who are deemed unsuitable for vaccination by the investigator after comprehensive evaluation;\n* Persons with a confirmed history of diphtheria, tetanus, or pertussis within the past 5 years; or persons who have had close contact with individuals diagnosed with pertussis, diphtheria, or tetanus within the past 30 days;\n* Persons who have experienced persistent cough ≥14 days without fever in the absence of other specific etiologies (e.g., influenza) within the past 6 months;\n* Persons known to be allergic to any component of the investigational vaccine used in this clinical trial, or who had allergic reactions following previous administration of the same type of vaccine; persons with a history of severe allergy to any vaccine or drug, including but not limited to severe urticaria, anaphylactic shock, dyspnea, angioneurotic edema, anaphylactoid purpura, local allergic necrotizing reaction (Arthus reaction), etc.;\n* Persons with a history or family history of convulsions, epilepsy, encephalopathy (e.g., brain nerve tissue damage caused by congenital brain dysplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection, chemical drug poisoning, etc.), or mental illness;\n* Persons with primary or secondary immune impairment (e.g., severe history of or resection of thyroid, pancreas, liver, spleen, or kidney diseases, autoimmune diseases, malignant tumors, or requiring treatment for thyroid immune dysfunction diseases within the past 12 months);\n* Long-term use of immunosuppressants or other immunomodulatory drugs within 3 months before enrollment (e.g., prednisone or equivalent dose of similar drugs used at ≥0.5 mg\u002Fkg\u002Fday for trial participants aged 10-17 years, or ≥20 mg\u002Fday for trial participants aged 18-60 years, for 14 consecutive days or more);\n* Persons diagnosed by a physician with coagulation abnormalities (e.g., coagulation factor deficiency, coagulopathy, platelet abnormalities) or coagulation disorders;\n* Persons who have received immune globulin, blood or blood-related products within the past 3 months, plan to use such products during the trial, or have a history of blood transfusion within the past 3 months;\n* Persons with any acute infectious disease, febrile illness (axillary body temperature ≥38.0°C), cardiopulmonary disease (frequently occurring asthma), acute exacerbation of chronic diseases, or use of antipyretic, analgesic or antiallergic drugs within 3 days before vaccination;\n* Persons who have received other investigational drugs or vaccines within 1 month before vaccination, or plan to participate in or are currently participating in any other clinical trials;\n* Persons who have received live attenuated vaccines within 14 days before vaccination, or subunit vaccines or inactivated vaccines within 7 days before vaccination;\n* Persons with any other factors deemed unsuitable for participation in the clinical trial by the investigator.",true,"ALL","10 Years",{"count":20,"type":21},96,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","the safety and tolerability of different dosages of adsorbed acellular pertussis (two-component) diphtheria-tetanus combined vaccine",[27,28,29],"Pertussis (Whooping Cough)","Diphtheria","Tetanus","NOT_YET_RECRUITING","2026-03-19",{"date":33,"type":34},"2026-03-25","ACTUAL",{"date":36,"type":21},"2026-04-20",{"date":38,"type":21},"2027-08-20",{"name":40,"class":41},"Changchun BCHT Biotechnology Co.","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":4},"100619776","phase-1-a-phase-i-trial-to-evaluate-the-safety-and-immunogenicity-of-influenza-virus-split-vaccine-adjuvant-100619776","NCT07349017","A Phase I Trial to Evaluate the Safety and Immunogenicity of Influenza Virus Split Vaccine (Adjuvant)","A Single-Center, Randomized, Blinded Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Influenza Virus Vaccine (BK-01 Adjuvant) in Populations Aged 18 Years and Older","Inclusion Criteria:\n\n* Participants aged 18 years and above;\n* Have not received any influenza vaccine in the past six months and have no plan to receive other influenza vaccines during the trial period;\n* Have not had influenza in the past 6 months (confirmed by any clinical, serological, or microbiological method);\n* Able to obtain the participant's own informed consent;\n* The participant themselves can comply with the requirements of the clinical trial protocol.\n\nExclusion Criteria:\n\n* Axillary temperature \\> 37.0℃ on the day of enrollment;\n* Female participants of childbearing age with a positive urine pregnancy test result, or who are breastfeeding, or have a plan to have children within 12 months;\n* Those with a history of severe allergic diseases (such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrotic reaction), or who are allergic to any component of the test vaccine, such as eggs, gentamicin sulfate, formaldehyde, TritonX-100, etc.;\n* Those with clinically significant abnormal laboratory test results, which are determined by the researcher as unsuitable for vaccine vaccination；\n* Those who have had an acute illness, acute exacerbation of a chronic disease, or used antipyretic, analgesic, or anti-allergic drugs within the past 3 days;\n* Autoimmune diseases or immune deficiency, asplenia, functional asplenia, and asplenia or splenectomy caused by any condition; those who have received long-term systemic drugs within the past 3 months or plan to receive long-term systemic drugs during the trial, including immunosuppressive and\u002For immunomodulatory drugs, leukotoxic therapy, etc. (for more than 14 consecutive days);\n* Those with congenital malformations affecting organ function, Down's syndrome, major diseases or major potential diseases that may interfere with or hinder the completion of the trial (such as: severe cardiovascular or chronic diseases in the decompensated stage, cor pulmonale, pulmonary edema, severe liver and kidney diseases, severe or symptomatic diabetes, current malignant tumors, etc.);\n* Those with uncontrolled hypertension with drugs (18-59 years old: systolic blood pressure ≥ 140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg; ≥ 60 years old: systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg);\n* Those with a history or family history of mental and neurological diseases such as convulsions, epilepsy, encephalopathy, and psychosis; Those with contraindications to intramuscular injection and blood collection, such as: diagnosed with sickle cell anemia, thrombocytopenia, any coagulation disorder, or receiving anticoagulant therapy, etc.;\n* Those who have received blood products or immunoglobulin products within 3 months before receiving the test vaccine or plan to use them during the trial;\n* Those who have received other clinical trial drugs within 1 month before receiving the test vaccine or are participating in other clinical trials, received live attenuated vaccines, viral vector vaccines, or nucleic acid vaccines within 14 days, or received subunit, recombinant, or inactivated vaccines within 7 days;","18 Years",{"count":51,"type":21},160,[24],"The goal of this clinical trial is to evaluate the safety and immunogenicity of the influenza virus vaccine (BK-01 adjuvant) in people aged 18 years and older.\n\nThe main questions it aims to answer is:\n\n• Incidence rate of adverse reactions\u002Fevents after administration Participants will be randomly vaccinated with a single dose of the trial vaccine, control vaccine, adjuvant placebo, or placebo in a 1:1:1:1 ratio. After vaccination, all participants will undergo up to 30-day observation and blood collection.",[55],"Influenza","2026-01-09",{"date":58,"type":34},"2026-01-16",{"date":60,"type":21},"2026-02-07",{"date":62,"type":21},"2027-03-07",{"name":40,"class":41},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":16,"sex":17,"minAge":49,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":4},"100603229","phase-3-clinical-trial-to-evaluate-the-protective-efficacy-and-safety-of-a-nasal-spray-live-attenuated-influenza-vaccine-laiv-in-adults-aged-18-59-years-post-vaccination-100603229","NCT07133802","Clinical Trial to Evaluate the Protective Efficacy and Safety of a Nasal Spray Live Attenuated Influenza Vaccine (LAIV) in Adults Aged 18-59 Years Post-Vaccination","A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Protective Efficacy and Safety of a Nasal Spray Live Attenuated Influenza Vaccine in Adults Aged 18-59 Years","Inclusion Criteria:\n\n1. Healthy participants aged 18-59 years\n2. Capable of providing informed consent in person\n3. Willing and able to comply with all clinical trial requirements\n\nExclusion Criteria:\n\n1. Axillary temperature \\>37.0°C on enrollment day \\*\n2. Received any influenza vaccine within the past 6 months or plans to receive other influenza vaccines during the trial\n3. History of laboratory-confirmed influenza (by clinical, serological, or microbiological methods) within the past 6 months\n4. Female participants of childbearing potential with positive urine pregnancy test, currently breastfeeding, or planning pregnancy within 6 months\n5. Acute phase of any infectious disease\u002Fchronic illness within 3 days, or recent use (≤3 days) of antipyretics\u002Fanalgesics\u002Fantihistamines \\*\n6. History of severe allergies requiring medical intervention (e.g., anaphylaxis, angioedema, Arthus reaction) or hypersensitivity to vaccine components (egg proteins, gentamicin sulfate, etc.)\n7. Known malignancies, autoimmune diseases (e.g., SLE, rheumatoid arthritis), or immunodeficiency (HIV, organ transplantation, etc.)\n8. Asplenia, functional asplenia, or any splenectomy history\n9. Use of immunosuppressants\u002Fimmunomodulators (e.g., systemic corticosteroids \\>14 days) within 6 months or planned use during study\n10. Congenital anomalies affecting organ function, uncontrolled hypertension (≥140\u002F90 mmHg despite treatment), or severe hepatic\u002Frenal diseases (e.g., diabetes-complicated)\n11. Active asthma or clinical remission for \\\u003C12 months\n12. History or family history of neurological\u002Fpsychiatric disorders (e.g., epilepsy, Guillain-Barré syndrome)\n13. Salicylate use (e.g., aspirin) within 30 days or planned use within 6 weeks post-vaccination\n14. Nasal abnormalities potentially affecting vaccine administration (e.g., active allergic rhinitis with medication, ongoing nasal sprays)\n15. Blood products\u002Fimmunoglobulin administration within 3 months or planned use during trial\n16. Live-attenuated vaccines within 14 days or subunit\u002Finactivated vaccines within 7 days prior to enrollment \\*\n17. Participation in other clinical trials within 1 month or concurrent involvement in interventional studies\n18. Any condition deemed by investigators to compromise trial integrity","59 Years",{"count":73,"type":21},6680,[75],"PHASE3","A Clinical Trial to Evaluate the Protective Efficacy and Safety of a Nasal Spray Live Attenuated Influenza Vaccine (LAIV) in Adults Aged 18-59 Years Post-Vaccination",[78],"Prevention of Influenza","2025-08-14",{"date":81,"type":34},"2025-08-21",{"date":83,"type":21},"2025-08",{"date":85,"type":21},"2026-07",{"name":40,"class":41},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":16,"sex":17,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},"100601565","phase-3-adsorption-of-cell-free-diphtheria-and-tetanus-three-component-combined-with-vaccine-phase-iii-clinical-trial-100601565","NCT07112144","Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial","Phase III Clinical Trials to Evaluate the Immunogenicity and Safety of Adsorption-free Diphtheria and Tetanus (Three-component) Combined Vaccine in 2-month-old Infants and Young Children","Inclusion Criteria:\n\n1. Healthy infants and young children who are permanent residents aged 2 months (60-89 days), and can provide valid identification documents for the subject and their legal guardian;\n2. Obtain the informed consent of the subject's legal guardian and sign the informed consent form;\n3. The legal guardian of the subject can comply with the requirements of the clinical trial protocol.\n\nExclusion Criteria:\n\n1. History of pertussis, diphtheria, or tetanus;\n2. Contact with individuals diagnosed with pertussis or diphtheria within the past 30 days;\n3. Vaccination with vaccines containing DTaP components, inactivated poliovirus vaccine, 13-valent pneumococcal polysaccharide conjugate vaccine, or Hib vaccine;\n4. Premature infants (born before 37 weeks of gestation), infants with severe abnormal labor processes or a history of asphyxia rescue, or low birth weight infants (\\\u003C2500g);\n5. Axillary temperature \\>37.0°C on the day of enrollment\\*;\n6. Severe congenital malformations or developmental disorders, genetic defects, severe malnutrition, or congenital diseases (such as Down syndrome, sickle cell anemia, congenital nervous system diseases, etc.);\n7. History of epilepsy, convulsions, or seizures, history of cerebral palsy, or family history of mental illness;\n8. Autoimmune diseases or immunodeficiencies (such as perianal abscesses suggesting possible immunodeficiency in infants, human immunodeficiency virus infection, lymphoma, leukemia, etc.), or parents\u002Fsiblings with autoimmune diseases or immunodeficiencies;\n9. Asplenia or splenic dysfunction due to any cause;\n10. Clinically diagnosed coagulation disorders (such as coagulation factor deficiencies, coagulation diseases, platelet abnormalities) or obvious bruising\u002Fcoagulation disorders that may contraindicate intramuscular injection;\n11. History of severe allergic diseases (such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrotic reactions), history of severe allergic reactions to any vaccine (widespread urticaria, angioedema, etc.), or allergy to any known component of the test vaccine (pertussis toxoid, filamentous hemagglutinin, 69KD outer membrane protein, diphtheria toxoid, tetanus toxoid, aluminum hydroxide, sodium chloride, sodium hydroxide, etc.);\n12. Vaccination with subunit or inactivated vaccines within the past 7 days; vaccination with live attenuated vaccines within the past 14 days\\*;\n13. Receipt of immunoglobulin and\u002For any blood products (except hepatitis B immunoglobulin) before enrollment;\n14. Receipt of any immunostimulant or immunosuppressant therapy before enrollment (continuous oral administration or infusion for ≥14 days, or topical steroid use \\[inhaled, nasal spray, intra-articular, eye drops, ointments, etc.\\] exceeding the recommended dosage in the package insert);\n15. Suffering from acute illnesses within 3 days before enrollment (acute illness is defined as moderate or severe illness with or without fever)\\*;\n16. Administration of prophylactic medications (such as antipyretic analgesics, antiallergic drugs, antidiarrheal drugs, etc.) within 3 days before enrollment\\*;\n17. Known or suspected severe clinically diagnosed diseases (including but not limited to severe diseases of the nervous, cardiovascular, hematological and lymphatic, immune, renal, hepatic, gastrointestinal, respiratory, metabolic, and skeletal systems, as well as a history of malignant tumors);\n18. Currently participating in other clinical trials or planning to participate in other trials during the study period;\n19. Any other factors that, in the judgment of the researcher, make the subject unsuitable for participating in the clinical trial.","2 Months","3 Months",{"count":97,"type":21},1650,[75],"The immunogenicity and safety of the adsorption of cell-free diphtheria and tetanus (three-component) combined vaccine were evaluated at 2 months, 4 months and 6 months.",[101,102,103],"Prevent Whooping Cough","Prevent Diphtheria","Prevent Tetanus","RECRUITING","2025-08-01",{"date":107,"type":34},"2025-08-08",{"date":109,"type":34},"2025-06-13",{"date":111,"type":21},"2032-06",{"name":40,"class":41},1,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":16,"sex":17,"minAge":120,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":4},"100590000","phase-4-a-multicenter-randomized-double-blind-placebo-controlled-phase-iv-clinical-trial-to-evaluate-the-immunogenicity-and-safety-of-a-live-attenuated-herpes-zoster-vaccine-in-adults-aged-40-years-and-older-100590000","NCT06961721","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of a Live Attenuated Herpes Zoster Vaccine in Adults Aged 40 Years and Older","Inclusion Criteria:\n\n1. Age ≥40 years on enrollment day；\n2. The informed consent of the subject can be obtained and signed；\n3. The subjects themselves were able to complete the trial in accordance with the requirements of the clinical trial protocol；\n4. Armpit body temperature ≤37.0℃ on the day of enrollment.\n\nExclusion Criteria:\n\n1. People who are immune deficient or immunosuppressed due to certain diseases or treatments. Causes of immunodeficiency or immunosuppression may include, but are not limited to, primary or acquired immunodeficiency conditions, such as AIDS or other diseases caused by viral infection; Leukemia, lymphoma, or other malignancies affecting the bone marrow or lymphatic system; Being treated for immunosuppression; Being treated with radiation\u002Fchemotherapy for a tumor；\n2. Do not use in persons with a history of allergic reaction to any of the components contained in this product；\n3. Those who are in the acute stage of acute infection and chronic infection should postpone the vaccination of this product；\n4. Premenopausal women who tested positive for pregnancy, pregnant women, breastfeeding women, or those who planned to have a baby within 6 months；\n5. If this product and other injectable live attenuated vaccines are not administered at the same time, the interval should be at least 28 days；\n6. Treatment with whole blood, plasma, or immunoglobulin is given within 5 months or 3 weeks prior to vaccination；\n7. Received another investigational drug within 1 month prior to receiving the investigational vaccine\u002Fplacebo, or is participating in another clinical trial, or plans to use it during the study；\n8. Taking or about to take salicylate drugs, including aspirin and difluorosalicylic acid；\n9. Patients with abnormal blood pressure that cannot be controlled by medication (systolic blood pressure ≥160mmHg and\u002For diastolic blood pressure ≥100mmHg)；\n10. Previous vaccinations against chickenpox or shingles (including use of registered products or participation in clinical trials of chickenpox or shingles vaccine)；\n11. Any situation that the investigator considers likely to affect the evaluation of the trial。","40 Years",{"count":122,"type":21},600,[124],"PHASE4","To evaluate the immunogenicity 42 days after vaccination with the live attenuated herpes zoster vaccine.\n\nTo evaluate the safety of the live attenuated herpes zoster vaccine.",[127],"Prevention of Herpes Zoster",[129,130,131,127],"IV Clinical Trial","Herpes Zoster Vaccine, Live","Herpes Zoster","2025-05-06",{"date":134,"type":34},"2025-05-08",{"date":136,"type":21},"2025-05",{"date":138,"type":21},"2025-12",{"name":40,"class":41},{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":16,"sex":17,"minAge":49,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":150,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":113},"100558209","phase-2-rabies-mab-cbb-1-combination-vaccine-in-healthy-people-with-antibody-neutralization-activity-and-safety-phase-clinical-trials-100558209","NCT06548139","Rabies mAb CBB 1 Combination Vaccine in Healthy People With Antibody Neutralization Activity and Safety Phase Clinical Trials","Multicenter, Randomized, Double-blind, Positive Control Evaluation of Rabies Monomab CBB 1 Combination Vaccine for Antibody Neutralization Activity and Safety Phase Clinical Trials in Healthy People","Inclusion Criteria:\n\n1. Before the trial, I have had a detailed understanding of the nature, significance and possible benefits of the trial, the possible inconvenience and potential risks and discomfort, and volunteered to participate in this clinical trial, was able to communicate well with researchers, comply with the requirements of the whole study, and signed a written informed consent;\n2. Men or women aged 18\\~50 (including boundary values) at the time of screening;\n3. The weight of female volunteers was 45.0 kg and 80.0 kg, that of male volunteers was 50.0 kg and 80.0 kg, and the body mass index (BMI) was between 18.0 and 27.0 kg\u002Fm2 (including boundary value) (BMI= weight kg \u002F height m2);\n4. Female volunteers have no fertility or egg donation plan within 14 days before the first dose to 3 months after the end of the trial and voluntarily take effective physical contraception, while male volunteers have no fertility or sperm donation plan within 3 months after the first dose to the trial and voluntarily take effective physical contraception.\n\nExclusion Criteria:\n\n1. Those who are known to be allergic to the study drug (including excipients, similar drugs), or suffer from severe allergic diseases or allergic constitution (such as allergic to two or more drugs, food or pollen), may damage the safety of the volunteers in the judgment of the investigator (inquiry);\n2. Those with a clear history of allergy to the essential substances (such as skin disinfectants) that may be exposed to during the test (inquiry);\n3. Patients with a history of clinically serious disease within 6 months (180 days) before the first dose and not cured, or patients with acute or chronic diseases that may significantly affect the in vivo process or safety evaluation of the study drug (inquiry);\n4. Patients with a previous history of autoimmune diseases or chronic hepatitis (inquiry);\n5. Patients with a previous history of convulsions, epilepsy, mental or nervous system, or a family history of convulsions or epilepsy (inquiry);\n6. Those who have received major surgery within 3 months (90 days) prior to the first dose, or those who may significantly affect the internal process or safety evaluation of the study drug (inquiry, inquiry);\n7. Patients with a history of rabies virus infection or have received rabies vaccination (inquiry);\n8. Suspected or clear identification of a history of injuries to warm-blooded mammals in the last 12 months (360 days) (warm-blooded animals refer to animals that can regulate their body temperature, also known as endotherms. Birds and the vast majority of mammals, including the cats and dogs around them, are warm-blooded animals) (inquiry);\n9. Having received a vaccine other than the rabies vaccine within 1 month (30 days) prior to the first dose (inquiry);\n10. Those who have used a rabies passive immunization preparation or used systemic immunosuppressive agents such as glucocorticoids within 3 months (90 days) prior to the first dose (inquiry, inquiry)；\n11. Those who have been used or are in the current period) or who may have a significant impact on the in vivo process or safety evaluation of the study drug (inquiry, inquiry);\n12. Any clinical trial drug or device used within 3 months (90 days) prior to the first dose, or \\\u003C5 half-lives of the last previous trial drug dose (whichever is older), or planned to participate in other clinical trials during the study (inquiry, inquiry);\n13. Regular alcohol for 3 months (90 days) before the first dose (3 times a week, and an average of 50° of liquor 200 ml) (inquiry);\n14. Those with positive alcohol breath test or test value\\> 0 mg \u002F 100 ml (examination);\n15. Cigarette addiction (more than 10 cigarettes or the same amount of tobacco per day) within 1 month (30 days) before the first dose (inquiry);\n16. Those who lost blood \u002F donated more than 400 ml (other than female physiological blood loss) within 3 months (90 days) before the first dose, or who received blood transfusion or used blood products, or planned to donate blood during the trial or within 1 month (30 days) after the end of the trial (inquiry);\n17. Those who ingested alcohol-containing products within 24 hours before the first dose (inquiry);\n18. Abnormalities at the administration site (such as inflammation, induration, redness, large area scar or tattoo, etc.) shall affect the administration or the clinical observer (examination);\n19. Those with a history of substance abuse (inquiry);\n20. Those who are screened positive for substance abuse during the screening period (examination);\n21. Those who are positive for the initial HIV screening during the screening period (screening);\n22. two half and half qualitative tests of hepatitis B during the screening period (examination);\n23. Patients with positive results for hepatitis C virus antibody or treponema pallidum antibody during the screening period (examination);\n24. Physical examination, vital signs (respiration, blood pressure, pulse rate), electrocardiogram, other laboratory tests (laboratory tests not listed separately) or other auxiliary examination results are judged as abnormal and clinically significant by the study doctor (examination);\n25. Ear temperature during the screening period is\\> 37.5℃ (examination);\n26. Women who are positive in pregnancy or lactation or screening pregnancy test (inquiry, examination);\n27. Patients with a history of needle acupuncture, blood sickness, or unable to tolerate venipuncture (inquiry);\n28. The volunteers may be unable to cooperate with the study for other reasons or the investigators is not unsuitable for inclusion.","50 Years",{"count":149,"type":21},120,[151],"PHASE2","To evaluate the antibody neutralization activity and safety of rabies mAb CBB 1 combination vaccine used in healthy people",[154],"Rabies Virus Infection",[156,157,158],"Rabies Virus Neutralizing Antibodies","Safety","Immunogenicity","2024-08-06",{"date":161,"type":34},"2024-08-12",{"date":163,"type":21},"2024-07-31",{"date":165,"type":21},"2025-05-31",{"name":40,"class":41},""]