[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Aimei Vacin BioPharm (Zhejiang) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100640545","phase-1-phase-i-clinical-trial-of-adsorbed-tetanus-vaccine-100640545",false,"NCT07598890","Phase I Clinical Trial of Adsorbed Tetanus Vaccine","A Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Adsorbed Tetanus Vaccine in Participants Aged ≥18 Years","Inclusion Criteria:\n\n1. Participants aged ≥ 18 years.\n2. Able to provide valid personal identification.\n3. Able to provide their own informed consent, voluntarily participate in the trial, and sign the informed consent form; able to use a thermometer and ruler, and complete diary\u002Fcontact cards as required.\n4. Able to comply with the trial protocol, attend scheduled examinations, and cooperate with follow-up visits.\n\nExclusion Criteria:\n\nThe following criteria will be assessed during screening\u002Fenrollment. Participants meeting any of the following conditions will be excluded from the trial. (Participants meeting only the exclusion criteria marked with an asterisk (\\*) may be rescheduled for screening.)\n\n1. History of confirmed tetanus infection.\n2. Receipt of tetanus vaccine or vaccines containing tetanus toxoid component (such as DTaP, DT, or vaccines using tetanus toxoid as carrier) within 10 years; or administration of tetanus immunoglobulin (human or animal origin) within 6 months.\n3. Axillary temperature \\> 37.0 ℃ on the day of vaccination before inoculation\\*.\n4. Abnormal laboratory findings in complete blood count, blood biochemistry and routine urinalysis during the screening period, which are judged to be clinically significant by the investigator.\n5. Presence of any acute disease or acute exacerbation of chronic disease within 3 days before vaccination.\n6. Receipt of the following medications or vaccines before vaccination\\*:\n\n   * Have used antipyretic, analgesic or anti-allergic drugs within 3 days before vaccination;\n   * Have received inactivated vaccines, subunit vaccines or other non-live vaccines within 7 days (inclusive);\n   * Have received live attenuated vaccines within 14 days (inclusive);\n   * Have used blood products including gamma globulin or immunoglobulin therapy within 3 months;\n   * Have used long-term (continuous use ≥ 14 days) immunosuppressants or other immunomodulatory drugs (e.g., corticosteroids such as prednisone or similar drugs) within 6 months; however, topical medications (e.g., ointments, eye drops, inhalants or nasal sprays) are permitted, provided the dose should not exceed the recommended dose in the product labeling.\n7. Positive urine pregnancy test, inability to rule out pregnancy before vaccination, or breastfeeding status; For women of childbearing potential who are pre-menopausal: last menstrual period more than 1 month ago, or plan to become pregnant within 6 months after enrollment (applicable only to female participants of childbearing potential).\n8. History of severe allergic diseases or severe adverse reactions to vaccines (such as anaphylactic shock, allergic laryngeal edema, allergic purpura, local allergic necrosis reaction (Arthus reaction), severe urticaria, angioneurotic edema, etc.), or allergy to any component of the investigational vaccine.\n9. History of confirmed thrombocytopenia or other coagulation disorders that may constitute a contraindication to intramuscular injection.\n10. History of congenital or acquired immunodeficiency or autoimmune diseases, such as autoimmune diseases (e.g., systemic lupus erythematosus), immunodeficiency (e.g., acquired immunodeficiency syndrome), lymphoma, leukemia, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other immune-related diseases or immunocompromised conditions that may interfere with trial evaluation as judged by the investigator.\n11. Asplenia or functional asplenia, and asplenia or splenectomy caused by any conditions.\n12. Presence of congenital malformations affecting organ function, developmental disorders, Down syndrome, sickle cell anemia, or any severe or potentially severe diseases that may interfere with trial completion; including but not limited to respiratory diseases such as asthma, uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg), pulmonary diseases, cardiovascular and cerebrovascular diseases, hepatic and renal diseases, malignant tumors, type I diabetes, uncontrolled type Ⅱ diabetes, infectious or allergic skin diseases.\n13. History of neurological diseases such as epilepsy, Parkinson's disease, Guillain-Barré syndrome, convulsions (excluding simple febrile seizures), or progressive neurological disorders.\n14. Previous or current history of psychiatric\u002Fpsychological disorders including dementia, schizophrenia, depression, autism, delusional disorder, abulia, bipolar disorder, etc.\n15. Currently participating in or planning to participate in other clinical trials during this trial period.\n16. Plan to permanently move from the local area before the end of the trial, or plan to leave the local area for a long period that will affect scheduled trial visits.\n17. Any other condition that may interfere with the trial evaluation as judged by the investigator.",true,"ALL","18 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a randomized, double-blind, parallel-controlled Phase I clinical trial of Adsorbed Tetanus Vaccine. Participants aged ≥18 years will receive one dose of the vaccine to evaluate its safety and immunogenicity.",[27],"Tetanus","NOT_YET_RECRUITING","2026-05-20",{"date":31,"type":32},"2026-05-22","ACTUAL",{"date":34,"type":21},"2026-05-21",{"date":36,"type":21},"2027-03-21",{"name":38,"class":39},"Aimei Vacin BioPharm (Zhejiang) Co., Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":16,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":40},"100519479","phase-3-a-clinical-trial-to-evaluate-the-immunogenicity-and-safety-of-the-23-valent-pneumococcal-polysaccharide-vaccine-in-healthy-people-100519479","NCT06044077","A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People","A Randomized, Blinded, Parallel Controlled Phase 3 Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People Aged 2 Years and Above","Inclusion Criteria:\n\n1. Healthy subjects who meet the observation age of this clinical trial (2 years old and above) and are determined based on medical history, physical examination and the researcher's judgment;\n2. Subjects who voluntarily participate and\u002For the subjects' legal guardians Or the entrusted person voluntarily agrees for his or her child to participate and signs an informed consent form (subjects aged 8-17 years old must also sign an informed notification form);\n3. The subject and\u002For the subject's legal guardian or principal can abide by the clinical Relevant requirements of the research protocol;\n4. \\*Axillary body temperature \\\u003C37.3°C on the day of enrollment. For criteria marked with an asterisk (\\*), if the subject has the conditions specified in the criterion, the visit can be rescheduled when they no longer have those conditions.\n\nExclusion Criteria:\n\n1. Previous vaccination with marketed or experimental pneumococcal vaccines;\n2. Previous culture-confirmed history of invasive diseases caused by pneumococcal bacteria;\n3. History or family history of convulsions, epilepsy, encephalopathy, and mental illness;\n4. Have a history of severe allergy to any vaccination or drug in the past, be allergic to the ingredients of the experimental vaccine (mainly including pneumococcal polysaccharide, sodium dihydrogen phosphate, disodium hydrogen phosphate, and sodium chloride), and have a history of vaccination-related fever (39℃ or above );\n5. Known severe congenital malformations, developmental disabilities or clinically diagnosed serious chronic diseases (such as Down syndrome, diabetes that cannot be controlled by drugs, sickle cell anemia, Guillain-Barré syndrome);\n6. Known or suspected to have serious diseases including: severe respiratory diseases, severe digestive system diseases, severe endocrine system diseases, severe cardiovascular diseases, severe liver and kidney diseases, malignant tumors, severe skin diseases, etc.;\n7. Known or suspected to be immune Academic functional defects include: immunosuppressant treatment (radiotherapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), HIV infection, etc. within 6 months;\n8. Have received any treatment within 3 months before enrollment Blood products or globulin treatment, those who have used hepatitis B immune globulin are acceptable;\n9. Asplenia, functional asplenia or splenectomy;\n10. \\* In the acute infectious period (including recovery period) or acute exacerbation of chronic disease within 3 days before enrollment, or need or plan to use intravenous or oral steroids within 1 month after vaccination;\n11. \\* Antipyretic analgesics or anti-allergic drugs have been used within 3 days before enrollment;\n12. Women of childbearing age are pregnant ( Positive urine pregnancy test), breastfeeding or planning to prepare for pregnancy within six months; 13. \\*Hypertension that cannot be controlled by medication, such as systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg in adults aged 18 years and above before enrollment;\n\n14\\. \\* Have received attenuated live vaccines within 14 days before vaccination, and received inactivated vaccines within 7 days; 15. Are participating in or plan to participate in clinical studies of other drugs or vaccines within 6 months after vaccination (immune persistence observation subjects in the vaccine who plan to vaccinate any marketed or unmarketed pneumococcal vaccine within 6 years after vaccination need to be excluded); 16. The investigators evaluate that they are not suitable for participating in the study.\n\nFor criteria marked with an asterisk (\\*), if the subject has the conditions specified in the criterion, the visit can be rescheduled when they no longer have those conditions.","2 Years",{"count":50,"type":21},1920,[52],"PHASE3","This study is a randomized, blinded, parallel controlled phase 3 clinical trial to evaluate the immunogenicity and safety of the 23-valent pneumococcal polysaccharide vaccine in healthy people aged 2 years and above.",[55],"Pneumococcal Disease","RECRUITING","2023-09-19",{"date":59,"type":32},"2023-09-21",{"date":61,"type":32},"2023-09-08",{"date":63,"type":21},"2029-07-31",{"name":38,"class":39},""]