[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tetanus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tetanus":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,40,65,102,124,147,176,201,299,319,341,369,394,417,442],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100643376","phase-3-a-phase--clinical-study-of-sna02-48-injection-100643376",false,"NCT07633119","A Phase Ⅲ Clinical Study of SNA02-48 Injection","A Multicenter, Randomized, Double-Blind, Active-Controlled Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of SNA02-48 Injection in Populations With High-Risk Tetanus Exposure","Inclusion Criteria:\n\n1. Males or females aged 18 years and above;\n2. Participants who can understand and voluntarily sign the informed consent form;\n3. Participants with high-risk tetanus exposure;\n4. Participants of childbearing potential and their sexual partners voluntarily adopt effective contraceptive measures from the time the participant signs the informed consent form until 6 months after administration, with no plans for sperm or egg donation.\n\nExclusion Criteria:\n\n1. Suspected or confirmed tetanus ;\n2. A history of previous tetanus infection;\n3. A known history of 3 or more doses of tetanus toxoid or vaccines containing tetanus toxoid, or fewer than 3 previous doses but with the last dose of tetanus toxoid or vaccines containing tetanus toxoid administered within 6 months prior to the administration of the investigational product;\n4. Known hypersensitivity to the investigational product (including excipients, HTIG, and other therapeutic monoclonal antibodies), or suffering from severe allergic diseases that, in the investigator's judgment, may impair the participant's safety; Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":19,"type":20},600,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The primary objective of this clinical trial is to compare the efficacy and safety of SNA02-48 injection with Human Tetanus Immunoglobulin (HTIG) for tetanus prophylaxis.",[26],"Tetanus","NOT_YET_RECRUITING","2026-06-02",{"date":30,"type":31},"2026-06-08","ACTUAL",{"date":33,"type":20},"2026-06-28",{"date":35,"type":20},"2027-05-31",{"name":37,"class":38},"Sinovac Life Sciences Co., Ltd.","INDUSTRY",30,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":4},"100639772","phase-4-a-first-in-human-study-investigating-the-safety-of-an-unloaded-and-loaded-with-a-tetanus-containing-vaccine-booster-microneedle-patch-in-healthy-adults-100639772","NCT07624669","A First in Human Study Investigating the Safety of an Unloaded and Loaded (With a Tetanus-containing Vaccine Booster) Microneedle Patch in Healthy Adults","A First-In-Human, Randomised, Double-Blind, Controlled Pilot Study to Evaluate the Safety and Tolerability of Microneedle Solutions Ltd's Unloaded and Fixed-Dose Tetanus- Containing Vaccine Loaded Miracus™ Patch in Healthy Adults","Miracus™ FIH","Inclusion Criteria:\n\n* Healthy male or female adults aged \\>16 years.\n* Minimum 27x27mm patch of hairless skin on the upper flexor forearm that is not affected by any clinically significant dermatological condition at the intended application site (upper flexor forearm), including but not limited to active inflammatory dermatoses (e.g., eczema, psoriasis), infection (bacterial, viral, or fungal), scarring or keloids, sun or chemical burn, pigmentary disorders that may interfere with assessment, autoimmune or bullous disease, vascular or purpuric lesions, open wounds, tattoos at the application site, or any other skin abnormality that, in the opinion of the Investigator, could interfere with study assessments or increase risk to the participant.\n* Able to provide written informed consent.\n* Postmenopausal women aged 45 and above who have not had a period for at least 12 months and are not using hormonal contraception.\n* Females of child-bearing potential must agree to use medically approved methods for birth control including condoms with or without spermicides, hormonal contraceptives (oestrogen and\u002For progestin products; either oral, intrauterine, or epidermal) or intrauterine device with copper.\n\nWilling to comply with all study procedures and attend all scheduled visits.\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to Tetanus containing vaccine or any skin-contacting components of the Miracus™ patches (polyvinylpyrrolidone (PVP), Polycarbonate (PC), acrylic and\u002For silicone).\n* Prior Tetanus Containing Vaccine booster within the last 12 months. .\n* Participation in another IMP clinical trial within the last 30 days.\n* Use of systemic immunosuppressive or immunomodulatory medication within 30 days prior to first study intervention, including but not limited to systemic corticosteroids (≥10 mg\u002Fday prednisone equivalent for \\>14 days), biologic agents, monoclonal antibodies, calcineurin inhibitors, antimetabolites, cytotoxic agents, or JAK inhibitors, or any other systemic or topical medications that, in the opinion of the investigator, may affect skin condition or immune response. - - Topical, inhaled, or intranasal corticosteroids are permitted if, in the opinion of the Investigator, they are not expected to result in clinically meaningful systemic immunosuppression.\n* Evidence of active systemic infection, defined as clinically significant abnormalities in haematology, inflammatory markers (e.g., elevated WBC count or CRP), positive infection serology, or other laboratory findings consistent with acute infection, as determined by the Investigator.\n* Pregnant or lactating female, or pregnancy planned during the trial.\n* Presenting a psychological or linguistic incapacity to understand and sign the informed consent form.\n* Employees of the Sponsor or study site who are directly involved in the design, conduct, oversight, or analysis of the study, and their immediate family members. Other hospital or institutional staff not involved in the study may participate, provided there is no direct supervisory or dependent relationship with study personnel.",true,"16 Years",{"count":39,"type":20},[52],"PHASE4","The purpose of this research study is to check whether the MNS Miracus Patch (the study's investigational device, a small patch made up of microneedles that dissolve in the skin and can potentially deliver vaccines in a pain-free way) is safe to use and tolerated by humans when administered for 10 minutes, both as a plain patch (with no vaccine) and as a loaded patch (with the tetanus- containing vaccine included). This study will also investigate whether the patch delivers the correct dose of the vaccine in the loaded patches by checking the immune response of participants.\n\nAs the device has not been tested clinically in humans before, this will be a first-in-human study involving healthy participants only, who have not previously received the full course of tetanus diphtheria vaccinations. This research study will take approximately 4-6 weeks of the participants' time.\n\nThe study consists of a screening period up to 2 weeks to determine if participants are eligible for the study. Upon confirmation of eligibility, participants will enter the 'double-blind' study where they will receive one patch in clinic.\n\nDouble-blind means that neither the participant nor the study doctor will know if the individual is receiving the empty or loaded patch. Participants will be randomly selected to receive the empty or loaded patch, and the number of participants will be equal in each group.\n\nDuring the study, participants will be asked to complete questionnaires, have photographs taken of their skin, give blood and urine samples and undergo general health checks including physical exam and vital signs.\n\nThe clinical trial is funded by Microneedle Solutions Ltd. And Innovate UK, and will recruit 30 participants at one site in the UK only.",[55,26],"Vaccine Delivery","2026-06-01",{"date":58,"type":31},"2026-06-03",{"date":60,"type":20},"2026-08",{"date":62,"type":20},"2026-11",{"name":64,"class":38},"Microneedle Solutions Ltd",{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":48,"sex":16,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100638753","phase-4-maternal-immunization-with-tetanus-toxoid-reduced-diphtheria-toxoid-reduced-dose-2-g-recombinant-pertussis-vaccine-tdap2gen-and-its-effect-on-the-immune-response-in-thai-infants-up-to-15-18-months-old-100638753","NCT07621341","Maternal Immunization With Tetanus Toxoid, Reduced Diphtheria Toxoid, Reduced-dose (2 µg) Recombinant Pertussis Vaccine (TdaP2gen) and Its Effect on the Immune Response in Thai Infants up to 15-18 Months Old","Maternal Immunization With Tetanus Toxoid, Reduced Diphtheria Toxoid, Reduced-dose (2 µg) Recombinant Pertussis Vaccine (TdaP2gen) and Its Effect on the Immune Response to Tetanus, Diphtheria and Pertussis in Thai Infants up to 15-18 Months Old: An Open-label, Randomized Controlled Trial","M-PRIME","Phase 1: Pregnant women\n\nInclusion Criteria:\n\n* Pregnant women aged 20 to 45 years\n* Healthy women in good general health\n* Gestational age between 20 and 32 weeks at enrollment\n* Singleton pregnancy\n* Low-risk, uncomplicated pregnancy as assessed by an obstetrician\n* No evidence of congenital anomalies identified on prenatal ultrasonographic screening\n* Willing to receive TdaP2gen vaccination and comply with collection of biological specimens as specified in the study protocol\n* Willing to allow their infant to receive either whole-cell pertussis-containing or acellular pertussis-containing combination vaccines according to the study randomization process, and to allow collection of biological specimens from the infant as specified in the study protocol\n* Able and willing to provide written informed consent prior to study participation\n\nExclusion Criteria:\n\n* Receipt of a tetanus-, diphtheria-, and chemical-detoxified pertussis-containing vaccine within 1 year prior to enrollment, or receipt of a tetanus-, diphtheria-, and genetic-detoxified pertussis-containing vaccine (TdaPgen) or genetic-detoxified acellular pertussis vaccine (aPgen) within 2 years prior to enrollment, including during the current pregnancy\n* History of laboratory-confirmed or clinically diagnosed pertussis infection within 1 year prior to enrollment\n* Presence of underlying medical conditions that may affect study outcomes, including but not limited to malignancy, autoimmune disease, immunodeficiency, epilepsy, hypertension, renal disease, or liver disease, as determined by the investigators\n* Pregnancy complications including hypertension (blood pressure \\>140\u002F90 mmHg with proteinuria, or \\>150\u002F100 mmHg regardless of proteinuria), current antihypertensive treatment, or preeclampsia\n* Endocrine disorders including hyperthyroidism, untreated hypothyroidism, or impaired glucose tolerance (e.g., type 1 or type 2 diabetes mellitus) diagnosed before or during pregnancy requiring treatment beyond dietary control\n* Severe or progressive neurological disorders, including epilepsy or a history of Guillain-Barré syndrome\n* Receipt of immunosuppressive agents, immunomodulatory agents, or high-dose systemic corticosteroids (\\>2 mg\u002Fkg\u002Fday, \\>20 mg\u002Fday, or equivalent) for more than 14 consecutive days within 6 months prior to enrollment\n* History of stillbirth, neonatal death, or recurrent spontaneous abortion (≥3 episodes).\n* Current medical or surgical treatment for prevention of preterm labor during the current pregnancy\n* Receipt of blood products, blood components, or immunoglobulins within 6 months prior to enrollment\n* Receipt of live attenuated vaccines within 3 months or any other vaccines within 28 days prior to enrollment\n* History of hypersensitivity or adverse reactions to study vaccines or vaccine components, or history of severe allergic reactions such as anaphylaxis to any vaccine\n* Behavioral, cognitive, or psychiatric conditions that, in the opinion of the investigator, may interfere with study participation or protocol compliance\n* History of smoking, alcohol abuse, or intravenous drug use that, in the opinion of the investigator, may interfere with study assessments or outcomes\n* Fever (body temperature ≥38.0°C or equivalent) within 72 hours prior to enrollment\n* Acute illness within 4 weeks prior to enrollment\n* Contraindications to intramuscular vaccination, including thrombocytopenia, coagulation disorders, hemophilia A or B, or use of anticoagulant therapy during pregnancy\n* Concurrent participation in another clinical study involving investigational vaccines or medications during participation in this study\n* Any medical or obstetric condition that, in the opinion of the study investigator, may interfere with study assessments or increase the risk to the mother or infant associated with study participation\n\nPhase 2: Infants\n\nInclusion Criteria:\n\n\\- All infants born to pregnant women enrolled in Phase 1 who received TdaP2gen vaccination during pregnancy will be eligible for enrollment to Phase 2 study\n\nExclusion Criteria:\n\n* Gestational age \\\u003C32 weeks (very preterm birth)\n* Birth weight \\\u003C1,500 grams (very low birth weight)\n* Presence of major congenital anomalies identified after birth, including congenital abnormalities associated with genetic disorders, congenital infections, or severe structural abnormalities involving major organ systems such as the central nervous system, cardiovascular system, respiratory system, hepatobiliary and gastrointestinal system, or genitourinary system\n* Presence of severe neonatal medical conditions that may affect immune responses to study vaccines, including but not limited to severe respiratory distress, severe bronchopulmonary dysplasia, hypoxic ischemic encephalopathy (HIE), severe intraventricular hemorrhage (IVH), severe sepsis, non-physiologic jaundice, neonatal autoimmune thrombocytopenia, neurological disorders such as neonatal convulsions, necrotizing enterocolitis, or intracranial hemorrhage\n* Presence of conditions associated with increased risk of serious adverse reactions to study vaccines\n* Any medical condition or circumstance that, in the opinion of the study investigator, may interfere with study assessments or increase the risk to the participant associated with study participation","0 Days","45 Years",{"count":76,"type":20},320,[52],"Pertussis remains a major global public health problem. In Thailand, pertussis vaccination is recommended during pregnancy at 20-32 weeks' gestation, together with routine childhood diphtheria-tetanus-pertussis vaccination administered as a primary series at 2, 4, and 6 months and booster doses at 18 months and 4-6 years of age.\n\nTdaP2gen, a newly developed combined tetanus, diphtheria, and recombinant genetically detoxified acellular pertussis vaccine containing 2 µg pertussis antigen, has shown favorable safety and non-inferior immunogenicity compared with existing pertussis vaccines. However, data on its use in pregnant women, transplacental antibody transfer, and potential immune interference in infants remain limited.\n\nThis study aims to evaluate the safety and immunogenicity of TdaP2gen in pregnant women, assess antibody transfer to newborns, and investigate immune responses to tetanus, diphtheria, and pertussis following primary and booster pertussis-containing vaccinations in infants and toddlers, including comparisons between whole-cell and acellular pertussis-containing vaccine schedules.",[80,81,26,82],"Pertussis","Diphtheria","Vaccine-Preventable Diseases",[84,85,86,87,88,89,90,91],"Safety","Immunogenicity","Immune interference","Pregnant women","Newborns","Infants and young children","Pertussis-containing vaccine","Genetically-detoxified recombinant acellular pertussis vaccine","2026-05-27",{"date":28,"type":31},{"date":95,"type":20},"2026-05-26",{"date":97,"type":20},"2030-12-31",{"name":99,"class":100},"Chiang Mai University","OTHER",1,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":101},"100640545","phase-1-phase-i-clinical-trial-of-adsorbed-tetanus-vaccine-100640545","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.",{"count":110,"type":20},80,[112],"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.",[26],"2026-05-20",{"date":117,"type":31},"2026-05-22",{"date":119,"type":20},"2026-05-21",{"date":121,"type":20},"2027-03-21",{"name":123,"class":38},"Aimei Vacin BioPharm (Zhejiang) Co., Ltd.",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":48,"sex":16,"minAge":131,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":21,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"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","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.","10 Years",{"count":133,"type":20},96,[112],"the safety and tolerability of different dosages of adsorbed acellular pertussis (two-component) diphtheria-tetanus combined vaccine",[137,81,26],"Pertussis (Whooping Cough)","2026-03-19",{"date":140,"type":31},"2026-03-25",{"date":142,"type":20},"2026-04-20",{"date":144,"type":20},"2027-08-20",{"name":146,"class":38},"Changchun BCHT Biotechnology Co.",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":48,"sex":16,"minAge":155,"maxAge":74,"enrollmentInfo":156,"targetDuration":4,"studyType":21,"phases":158,"briefSummary":160,"conditions":161,"keywords":162,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":101},"100627248","tetanus-antibody-detection-in-saliva-study-100627248","NCT07446166","TETANUS Antibody Detection in Saliva Study","Development of Novel Diagnostics That Use Point-of-care Lateral Flow Testing Technology for Non-invasive, Individual Assessment of Antibody Protection to Tetanus and Vaccine Need","TETANUS","Inclusion Criteria:\n\n* Able and willing to provide informed consent to take part in the study; either directly or from a parent\u002Fguardian, where appropriate\n* \\[Group A\\] Aged 5-10 years inclusive, and determined as healthy by a member of the study team\n* \\[Group B\\] Aged 18-25yrs inclusive, and determined as healthy by a member of the study team\n* \\[Group C\\] Currently pregnant at any stage of pregnancy, prior to receipt of a tetanus booster vaccine in pregnancy, and determined as healthy by a member of the study team and safe to provide a blood sample\n* \\[Group D\\] Adults aged 18-45 years with one or more of the medical conditions that may affect antibody response to vaccination.\n\nExclusion Criteria:\n\n* Participants or parents\u002Fguardians unwilling or unable to provide informed consent to take part\n* Unwilling or unable to comply with study procedures\n* Have a bleeding disorder deemed significant by study doctor\n* \\[Groups A, B and C only\\] Any health condition which, in the opinion of a study physician which could\n\n  1. mean blood sampling has the potential for harm and\u002For\n  2. affect immune response to a vaccine for example known\u002Fsuspected impairment of immune function (with the exception of Group D)","5 Years",{"count":157,"type":20},390,[159],"NA","This study aims to design, develop and optimise a non-invasive, saliva sample-based point-of-care lateral flow test for use in low and middle income settings that can return a qualitative result on whether an individual has or has not immunity to tetanus within 10-15mins. If successful, this approach would not require blood sampling or laboratory facilities, empower personalised decision making on vaccine needs and support the development of population level data-driven public health policies.",[26],[163,164,165,166],"point-of-care","Lateral Flow Test","Rapid Diagnostic","Immune Diagnostic","2026-02-25",{"date":169,"type":31},"2026-03-03",{"date":171,"type":20},"2026-02-01",{"date":173,"type":20},"2028-02-01",{"name":175,"class":100},"University of Birmingham",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":48,"sex":16,"minAge":183,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":21,"phases":186,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":101},"100625110","phase-1-phase-iii-clinical-trial-of-diphtheria-tetanus-pertussis-reduced-dose-vaccine-100625110","NCT07418372","Phase I\u002FII Clinical Trial of Diphtheria-Tetanus-Pertussis (Reduced Dose) Vaccine","A Randomized, Double-Blind, Parallel-Controlled Phase I\u002FII Clinical Trial Evaluating the Safety and Immunogenicity of Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content) Among Individuals Aged 6 Years and Above","Inclusion Criteria:\n\n* Age Requirement: volunteers aged 6 years and above\n* Provision of Legal Identification: volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.\n* Informed Consent: participants, legal guardians, or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time.\n\nExclusion Criteria:\n\n* Subjects whose physical examination, vital signs check, or laboratory test results are abnormal and have clinical significance, and are determined by the researcher to be unsuitable for participation in the clinical trial.\n* Subjects who have received any vaccine within 30 days (including the 30th day) before enrollment, or those who plan to receive other vaccines within 30 days (including the 30th day) after receiving the investigational vaccine.\n* Subjects who have experienced acute diseases (such as fever) or acute exacerbations of chronic diseases within 3 days before enrollment (including the third day).\n* Subjects who have had contact with patients clearly diagnosed with pertussis, diphtheria or tetanus within 30 days before enrollment.\n* Individuals who have been clinically diagnosed with diphtheria or tetanus within 10 years before enrollment, or with pertussis within 5 years; or those who have experienced paroxysmal spasmodic coughing for at least 14 days without fever within 5 years, and for which no other specific cause (such as influenza) can be identified, and have a history of exposure to pertussis or contact with confirmed cases.\n* Subjects who have been diagnosed with serious diseases that may interfere with the conduct or completion of the trial.\n* Subjects who have shown allergic reactions to any component of the trial vaccine (such as aluminum adjuvant) before enrollment, or have experienced severe allergic reactions, suspected severe allergies (such as Arthus reaction, anaphylactic shock, laryngeal edema, allergic purpura, local allergic necrotic reaction, etc.) or other serious adverse reactions (such as thrombocytopenic purpura, breathing difficulties, angioneurotic edema, widespread rash, brachial plexus neuritis, etc.) to any vaccine or drug before enrollment.\n* Subjects who have experienced convulsions, epilepsy, mental disorders before enrollment, or have a family history of such diseases, or have had severe brain diseases (such as hypoxic-ischemic encephalopathy, intracranial hemorrhage, cerebral palsy, intracranial tumors, cerebral infarction, stroke, etc.) before enrollment.\n* Subjects with coagulation disorders (such as deficiency of coagulation factors, coagulation diseases, and platelet abnormalities), or a history of bleeding disorders, or those with hereditary bleeding tendencies.\n* Individuals with primary or secondary immune function impairment, or those who have been receiving immunosuppressive therapy for a long time (such as long-term systemic glucocorticoid treatment, for example, using prednisone or similar drugs for two weeks or more continuously, but local use such as ointments, eye drops, inhalants or nasal sprays is allowed), or those who plan to use it during the trial.\n* Subjects who have had their spleen removed or undergone partial or complete removal of other vital organs (such as the liver, kidneys, lungs, pancreas, thyroid, stomach, intestines, and other vital organs) due to any cause.\n* Subjects who have donated blood or lost blood (≥ 400 ml) within 6 months before enrollment, received blood transfusion or used blood products, or plan to receive blood transfusion or use blood products during the trial.\n* Any investigational or unregistered products (drugs, biologics or devices) were used within 6 months before enrollment, or the subject plans to participate in or is currently participating in any clinical trial.\n* Subjects who may be unable to follow the trial procedures, abide by the agreement, or plan to permanently relocate from this area during the trial period, or be away from the local area for a long time during the scheduled visits.\n* Subjects deemed by the investigator to be unsuitable for participation in the study.","6 Years",{"count":185,"type":20},660,[112,187],"PHASE2","This is a randomized, double-blinded, parallel-controlled phase I\u002FII clinical trial to evaluate the safety and preliminary immunogenicity of the Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (reduced antigen content) in subjects aged 6 years and above.",[190,26,81,80,191],"Tetanus, Diphtheria and Acellular Pertussis Vaccination","Pertussis Vaccines","2026-02-11",{"date":194,"type":31},"2026-02-18",{"date":196,"type":20},"2026-03-12",{"date":198,"type":20},"2027-07-31",{"name":200,"class":100},"Institute of Medical Biology, Chinese Academy of Medical Sciences",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":48,"sex":16,"minAge":208,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":213,"conditions":214,"keywords":271,"overallStatus":289,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":101},"100620537","risk-assessment-of-community-spread-of-multiple-endemic-infectious-diseases-in-a-one-health-perspective-100620537","NCT07358910","Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective","RACSMEI","Inclusion Criteria:\n\n* Residency in the village for more than 6 months;\n* Age between 2 and 75 years old at the time of inclusion;\n* For adults: provision of written consent;\n* For children aged 2-17 years: written parental consent form, verbal assent from children aged 13-17 years;\n\nExclusion Criteria:\n\n* Unable to understand or consent;\n* Under guardianship or deprived of liberty;\n* Medical conditions that impede survey participation;\n* Refusal to participate in the study.","2 Years","75 Years",{"count":211,"type":20},10000,"OBSERVATIONAL","RACSMEI addresses the high burden of infectious diseases in low- and middle-income countries, including Cambodia, where limited surveillance and laboratory capacity often obscure etiologies and transmission dynamics. This knowledge gap hinders the design of effective prevention and control strategies.\n\nRACSMEI will improve understanding across multiple pathogens using a multidisciplinary One Health approach. We will answer key questions on burden, ecology, transmission and population immune status to inform targeted and culturally appropriate interventions. The project combines a nationally representative One Health survey, social-science methods, and multiplex, diverse diagnostics to efficiently test for 57 priority pathogens, including zoonotic and vector-borne agents, vaccine-preventable and elimination-targeted diseases, enteric, respiratory, and environmentally transmitted pathogens and selected neglected tropical diseases and parasites relevant to Cambodia.\n\nMathematical modelling will reconstruct and forecast transmission dynamics and assess the potential impact of future public-health strategies. By integrating intersectoral data and innovative methods, RACSMEI will generate actionable evidence for public-health authorities, support precision One Health interventions, and help reduce disease burden in affected communities. The project also aims to ensure the transferability of methods and insights to other countries facing similar challenges.",[215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,234,235,236,237,238,239,240,241,80,242,26,243,244,245,246,247,248,249,250,251,252,253,254,255,256,257,258,259,260,261,262,263,264,265,266,267,268,269,270],"Dengue","Chikungunya","Zika Virus Infection","Japanese Encephalitis","West Nile Virus","Tick-borne Encephalitis (TBE)","Severe Fever With Thrombocytopenia Syndrome","Nipah Virus Infection","Hantavirus Infections","Hepatitis E","Brucellosis","Q Fever","Leptospirosis","Melioidosis","Influenza A and B","Malaria","Yellow Fever","Mayaro Fever","Usutu Virus Infection","Oropouche Fever","Rift Valley Fever","Arenavirus Infections","Measles","Mumps","Rubella","Human Papilloma Virus (HPV)","Rotavirus Disease","Diphteria","Varicella","Hepatitis A","Norovirus Infections","Enterovirus","Adenovirus","Rhinovirus","Parvovirus","Respiratory Syncytial Virus (RSV)","Cytomegalovirus","Epstein Barr Virus","Salmonella Typhi","Vibrio Cholerae","Legionella Pneumophila Pneumonia","Mycoplasma","Chlamydia","Lymphatic Filariasis","Toxoplasma Gondii","Giardiasis","Entamoeba Histolytica","Leishmaniasis","Strongyloides Stercoralis Infection","Ascaris Lumbricoides","Trichuris Trichiura","Clonorchis Sinensis","Opisthorchis Viverrini","Schistosomiasis","Streptococcus Pneumoniae","Meningitis",[272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287,288],"Infectious disease","One Health","Population-based survey","Nationally representative survey","Seroepidemiology","Multiplex serology","Seroprevalence","Vector-borne diseases","Zoonoses","Vaccine-preventable diseases","Neglected tropical diseases","Transmission dynamics","Force of infection","Mathematical modelling","Spatial epidemiology","Precision public health","Cambodia","RECRUITING","2026-01-14",{"date":292,"type":31},"2026-01-22",{"date":294,"type":31},"2025-12-18",{"date":296,"type":20},"2027-09-30",{"name":298,"class":100},"Institut Pasteur du Cambodge",{"id":300,"slug":301,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":308,"conditions":309,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":101},"100619693","a-phase-4-study-to-evaluate-the-effectiveness-and-safety-of-siltartoxatug-injection-for-tetanus-prophylaxis-following-injury-100619693","NCT07347938","A Phase 4 Study to Evaluate the Effectiveness and Safety of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury","A Multicenter, Prospective, Non-Randomized, Open-Label, Active-Controlled Phase 4 Study to Evaluate the Effectiveness and Safety of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury","Inclusion Criteria:\n\n* Male or female aged ≥18 years.\n* Receiving siltartoxatug for tetanus prophylaxis per its approved labeling, or receiving another passive immunizing agent (human tetanus immunoglobulin \\[HTIG\\], tetanus antitoxin \\[TAT\\], or equine F(ab')₂ fragment \\[F(ab')₂\\]) for tetanus prophylaxis per its labeling.\n* Receiving or planned to receive standard wound management.\n* Providing written informed consent by the subject or their legally authorized representative.\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C3 months.\n* Severe cognitive impairment or other condition interfering with the assessment of tetanus development.\n* Currently participating in another interventional clinical trial (observational studies are permitted).",{"count":307,"type":20},6000,"Study sites were selected from hospitals across diverse regions of China. Approximately 6,000 participants who require passive immunization against tetanus due to various injuries (including those with severe wounds or heavily contaminated injuries) will be enrolled. Per clinical practice:\n\nParticipants receiving siltartoxatug for tetanus prophylaxis and meeting eligibility criteria will be assigned to the siltartoxatug group (n=4,000); Participants receiving other passive immunizing agents (HTIG, TAT, or F(ab')₂) for tetanus prophylaxis and meeting eligibility criteria will be assigned to the control group (n=2,000), comprising approximately 1,000 HTIG recipients and 1,000 TAT\u002FF(ab')₂ recipients. All clinical management decisions, including concomitant tetanus vaccination, will be made by investigators per standard clinical practice at each center.",[26],"2026-01-08",{"date":312,"type":31},"2026-01-16",{"date":314,"type":20},"2026-01-05",{"date":316,"type":20},"2029-03-31",{"name":318,"class":38},"Zhuhai Trinomab Pharmaceutical Co., Ltd.",{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":326,"targetDuration":327,"studyType":212,"phases":4,"briefSummary":328,"conditions":329,"keywords":330,"overallStatus":289,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":340},"100601241","a-registry-siltartoxatug-injection-for-tetanus-prophylaxis-following-injury-100601241","NCT07107932","A Registry： Siltartoxatug Injection for Tetanus Prophylaxis Following Injury","A Large-Sample Real-World Dynamic Cohort Registry: Observing the Clinical Outcomes of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury","Inclusion Criteria:\n\n* 1.Having received or will receive Siltartoxatug for tetanus prophylaxis following injury;\n* 2\\. Provided signed informed consent by themselves or their legal representatives.\n\nExclusion Criteria:\n\n* None",{"count":211,"type":20},"90 Days","The injury and wound conditions of the enrolled patients will be documented. A follow-up at 90 days post-administration will determine the clinical outcome of tetanus prophylaxis, specifically whether tetanus occurred. The registry will also employ selective safety data collection to record adverse reactions and serious adverse events following Siltartoxatug adminstration.",[26],[331],"Tetanus Prophylaxis","2026-01-04",{"date":334,"type":31},"2026-01-06",{"date":336,"type":31},"2025-07-31",{"date":338,"type":20},"2029-03-30",{"name":318,"class":38},4,{"id":342,"slug":343,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":48,"sex":16,"minAge":348,"maxAge":349,"enrollmentInfo":350,"targetDuration":4,"studyType":21,"phases":352,"briefSummary":353,"conditions":354,"keywords":358,"overallStatus":289,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":101},"100588906","phase-2-a-phase-iiiii-study-to-evaluate-the-immunogenicity-safety-and-lot-to-lot-consistency-of-lbvd-a-fully-liquid-hexavalent-diphtheria-tetanus-whole-cell-pertussis-hepatitis-b-poliovirus-haemophilus-influenzae-type-b-conjugate-dtwp-hepb-ipv-hib-vaccine-in-healthy-infants-as-primary-series-100588906","NCT06947499","A Phase II\u002FIII Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series","A Prospective, Multi-national, Multi-center, Open-label, Randomized, Active Controlled, Parallel Group, Operationally Seamless Phase II\u002FIII Clinical Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus (Inactivated)-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, Compared to Co-administration of DTwP-HepB-Hib Vaccine and IPV Vaccine in Healthy Infants at 6-, 10-, and 14-week of Age as Primary Series","Inclusion Criteria:\n\n* healthy infants from 6 weeks to 8 weeks of age (both inclusive)\n* body weight ≥ 3.2 kg\n* born at full term pregnancy (≥ 37 weeks)\n* signed informed consent by parent(s) or legally acceptable representative(s)\n\nExclusion Criteria:\n\n* Known history of Hib infection, HepB, diphtheria, tetanus, pertussis, or poliomyelitis\n* Household contact or intimate exposure with a confirmed case of Hib, HepB, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to study registration\n* Known history of SARS-CoV-2 infection\n* Participant's mother is HepB antigen or HIV positive\n* Fever ≥ 38.0 C\u002F100.4 F within 3 days prior to enrollment\n* Vaccination history of non-study vaccines within 30 days prior to enrollment except for pneumococcal conjugate, rotavirus, HepB and Bacillus Calmette Guerin (BCG)\n* Previous use of any diphtheria, tetanus, pertussis-based combination vaccine(s), Hib conjugate, poliovirus, or combination\n* Received immunosuppressive agents or other immune-modifying drugs\n* Previous use of blood or blood-derived products\n* Any history of allergy (hypersensitivity) to any of the vaccine components\n* Participation in another interventional clinical trial within 4 weeks of expected first vaccination","6 Weeks","8 Weeks",{"count":351,"type":20},1186,[187,23],"The purpose of this study is to evaluate immunogenicity, safety and lot-to-lot consistency of LBVD in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants",[81,26,80,355,356,357],"Hepatitis B","Poliomyelitis","Haemophilus Influenzae Type b",[359],"vaccination","2025-06-30",{"date":362,"type":31},"2025-07-03",{"date":364,"type":31},"2025-05-30",{"date":366,"type":20},"2027-04",{"name":368,"class":38},"LG Chem",{"id":370,"slug":371,"hasResults":11,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":21,"phases":378,"briefSummary":379,"conditions":380,"keywords":381,"overallStatus":289,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":393},"100564947","phase-3-a-phase-iii-clinical-trail-to-evaluate-the-efficacy-safety-pharmacokinetics-and-immunogenicity-characteristics-of-gr2001-injection-100564947","NCT06635798","A Phase III Clinical Trail to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR2001 Injection","A Multicentre, Randomized, Double-blind, Human Tetanus Immunoglobulin(HTIG) Controlled Phase III Clinical Trail to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR2001 Injection for Indication of Prophylaxis Against Tetanus","Inclusion Criteria:\n\n1. Chinese male or female adults aged ≥ 18 years；\n2. Participants with suspected tetanus exposure (due to dirty or contaminated wounds from various injuries);\n3. Participants who provide signed written informed consent form.\n\nExclusion Criteria:\n\n1. Participants known to be allergic to the investigational medicinal product or those suffering from severe allergic conditions；\n2. Suspect or diagnosed as tetanus;\n3. Previously diagnosed as Immunoglobulin A (IgA) deficiency with anti-IgA antibodies；\n4. Prior vaccination history of ≥ 3 doses of tetanus toxoid or tetanus toxoid- containing vaccine;\n5. Females who are pregnant or with pregnancy test positive.",{"count":377,"type":20},582,[23],"The goal of this clinical trial is to compare the efficacy and safety of GR2001 injection with Human Tetanus Immunoglobulin(HTIG) in tetanus prophylaxis. Patients will receive either GR2001 injection or HTIG on study D0.",[26],[26,382,383],"Human Tetanus Immunoglobulin","GR2001 Injection","2024-10-09",{"date":386,"type":31},"2024-10-10",{"date":388,"type":31},"2024-09-03",{"date":390,"type":20},"2025-03-04",{"name":392,"class":38},"Genrix (Shanghai) Biopharmaceutical Co., Ltd.",20,{"id":395,"slug":396,"hasResults":11,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":48,"sex":16,"minAge":401,"maxAge":402,"enrollmentInfo":403,"targetDuration":4,"studyType":21,"phases":405,"briefSummary":406,"conditions":407,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":4},"100563594","phase-2-study-to-evaluate-the-immunogenicity-of-lr20062-compared-to-control-when-administered-intramuscularly-in-healthy-infants-at-2-4-6-months-of-age-100563594","NCT06618196","Study to Evaluate the Immunogenicity of LR20062 Compared to Control When Administered Intramuscularly in Healthy Infants At 2, 4, 6 Months of Age","A Phase II, Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter Study to Evaluate the Immunogenicity and Safety of DTaP-HepB-IPV-Hib Hexavalent Vaccine LR20062 Versus Hexaxim Administered Intramuscularly in Healthy Infants As Primary Series At 2, 4, 6 Months of Age","Inclusion Criteria:\n\n1. Is male or female aged two months (50 to 70 days inclusive) on the day of the first dose of study vaccine.\n2. Is born at full term of pregnancy (≥37 weeks of gestation) with a birth weight of ≥2.5 kg.\n\nExclusion Criteria:\n\nMedical conditions:\n\n1. Has a history of diphtheria, tetanus, pertussis, poliovirus, Hep B, or Hib infection.\n2. Has a known SARS-CoV-2 infection at Screening.\n3. Was born to a mother with a known history of Hep B infection based on HBsAg seropositivity.\n4. Was born to a mother with a known history of HIV infection based on HIV antibody seropositivity.\n5. Had a recent febrile illness, defined as axillary temperature ≥38.0℃ \\[≥100.4℉\\] occurring at or within 72 hours prior to receipt of study vaccine.\n\n   Prior\u002Fconcomitant therapy:\n6. Has previously received vaccination against diphtheria, tetanus, pertussis, poliovirus, and\u002For Hib infections since birth.\n7. Has received or is expected to receive immunosuppressive agents or other immune-modifying drugs during the conduct of the study.\n8. Meets one or more of the following systemic corticosteroid exclusion criteria:\n\n   1. Has received systemic corticosteroids (equivalent of ≥0.5 mg\u002Fkg total daily dose of prednisone) for ≥14 consecutive days and has not completed treatment at least 30 days prior to Screening.\n   2. Is expected to require any systemic corticosteroids during conduct of the study.\n\n   Note: Topical, ophthalmic, and inhaled steroids are permitted at the discretion of the Investigator.\n9. Has received any non-study vaccine within 30 days before the first dose of study vaccine or is scheduled to receive any other vaccine within one month after the third dose of study vaccine.\n\nException: Vaccines against BCG and Hep B at birth, rotavirus, MMR, and PCV if received according to the routine immunization schedule, and inactivated influenza vaccine, are allowed.","50 Days","70 Days",{"count":404,"type":20},336,[187],"This is a phase II, randomized, double-blind, active-controlled, parallel-group, multicenter study to evaluate the immunogenicity and safety of DTaP-HepB-IPV-Hib hexavalent vaccine LR20062 in healthy infants as primary series at 2, 4, 6 months of age.",[81,26,80,355,356,408],"Haemophilus Influenzae Type B Infection","2024-09-26",{"date":411,"type":31},"2024-10-01",{"date":413,"type":20},"2024-10-02",{"date":415,"type":20},"2026-04-30",{"name":368,"class":38},{"id":418,"slug":419,"hasResults":11,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":48,"sex":16,"minAge":424,"maxAge":425,"enrollmentInfo":426,"targetDuration":4,"studyType":21,"phases":428,"briefSummary":429,"conditions":430,"keywords":4,"overallStatus":289,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":101},"100562637","safety-and-immunogenicity-of-dtap-ipvhib-pentavalent-vaccine-in-chinese-2-month-old-infants-100562637","NCT06605755","Safety and Immunogenicity of DTaP-IPV\u002FHib Pentavalent Vaccine in Chinese 2-month-old Infants","Extended Study on the Safety and Immunogenicity of DTaP-IPV\u002FHib Pentavalent Vaccine in Chinese 2-month-old Infants: a Randomized, Prospective, Open Clinical Study","Inclusion Criteria:\n\n\\- (1)Received 4 doses of DTaP-IPV\u002FHib pentavalent vaccines (2) Obtained consent from the participant's caregiver and sign an informed consent form\n\nExclusion Criteria:\n\n-(1) Diagnosed by a physician with a coagulation abnormality (e.g., coagulation factor deficiency, coagulopathy, platelet abnormality) (2) Any other factor considered to make participation in the trial unsuitable.","19 Months","22 Months",{"count":427,"type":20},785,[159],"The main purpose of this study is to evaluate immune persistence at 30 and 36 Months of Age and Pertussis Breakthrough Infections between 19 and 36 Months of Age following two regiments of DTaP-IPV\u002FHib Pentavalent Vaccine in Healthy 2-Month-Old Infants and Children in China.",[80,81,26,408,431],"Polio","2024-09-18",{"date":434,"type":31},"2024-09-20",{"date":436,"type":31},"2024-09-05",{"date":438,"type":20},"2026-02",{"name":440,"class":441},"Jiangsu Province Centers for Disease Control and Prevention","NETWORK",{"id":443,"slug":444,"hasResults":11,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":48,"sex":16,"minAge":449,"maxAge":183,"enrollmentInfo":450,"targetDuration":4,"studyType":21,"phases":452,"briefSummary":453,"conditions":454,"keywords":4,"overallStatus":289,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":463},"100530266","phase-1-phase-i-clinical-trial-of-diphtheria-tetanus-acellular-pertussis-component-combined-vaccine-100530266","NCT06184542","Phase I Clinical Trial of Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine","To Evaluate Safety and Preliminary Immunogenicity of the Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine in Children Aged 2 Months to 6 Years: A Randomized, Blinded, Active-controlled Phase I Clinical Trial","Inclusion Criteria:\n\n* Age Requirement: children aged 6 years, toddlers aged 18-24 months, and infants aged 2-3 months at the time of enrollment\n* Previous Vaccination Requirements: (a) Children (aged 6 years) enrolled in the study should have received four doses of the Diphtheria, Tetanus, and Pertussis combined vaccine, and not yet received the Diphtheria, Tetanus combined vaccine; (b) Toddlers (aged 18-24 months) enrolled in the study should have received three doses of Diphtheria, Tetanus, and Pertussis combined vaccine as well as three doses of the Polio vaccine, and not yet received the booster dose of Diphtheria, Tetanus, and Pertussis combined vaccine and the Polio vaccine; (c) Infants (aged 3 months) enrolled in the study should not have received diphtheria-tetanus-pertussis-containing vaccine, polio-containing vaccine, 13-valent pneumococcal polysaccharide conjugate vaccine, Haemophilus influenzae type b conjugate vaccine, or meningococcal group A and C polysaccharide conjugate vaccine; (d) Infants (aged 2 months) enrolled in the study should not received diphtheria-tetanus-pertussis-containing vaccine, polio-containing vaccine, 13-valent pneumococcal polysaccharide conjugate vaccine, or Haemophilus influenzae type b conjugate vaccine.\n* Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.\n* Informed Consent: Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time.\n* Birth Outcome Condition: Toddlers (aged 18-24 months) and Infants (aged 2-3 months) should be born at full term (37-42 weeks of gestation) with birth weight ≥2500g.\n* Temperature Requirement: Axillary body temperature is no more than 37.3°C.\n\nExclusion Criteria:\n\nSubjects meeting any of the following exclusion criteria will be not eligible for enrollment.\n\n* Previous Diagnosis: Subjects diagnosed with pertussis, tetanus, or diphtheria disease.\n* Special Conditions for Toddlers (aged 18-24 months) and Infants (aged 2-3 months): Subjects have been with abnormal labor (dystocia, instrumental delivery) or a history of asphyxia, nervous system damage, or clinically confirmed pathological jaundice.\n* Allergic History: Subjects have a history of allergies to any component of the vaccine (such as aluminum hydroxide), or previous allergy or suspected allergy to any vaccine, or other serious adverse reactions, such as anaphylactic shock, laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, local anaphylactic necrosis reaction, dyspnea, angioedema, systemic rash and\u002For urticaria.\n* Vaccination History: Subjects received any inactivated vaccines or subunit vaccines within 7 days before vaccination (except COVID-19 vaccines) with the investigational vaccine, or any other live attenuated vaccines or COVID-19 vaccines within 14 days before vaccination\n* Acute Illness: Subjects have acute illness (e.g., fever) or acute exacerbation of a chronic illness within 3 days before receipt of the first dose of the investigational vaccine\n* Neurological and Mental Health: Subjects have a history or family history of seizures, epilepsy, and other encephalopathy and psychiatric disorders.\n* Health Condition: Subjects have a major congenital malformation, developmental disability, or congenital disease (e.g., Down syndrome, sickle cell anemia, congenital neurological disorders), or other clinically diagnosed serious chronic disease, including but not limited to, serious diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolic system, skeletal system and other system and malignant tumor history.\n* Blood Disease: Subjects have genetic bleeding tendency or coagulopathy, or a history of bleeding disorders.\n* Infectious Disease: Subjects diagnosed with infectious diseases that may interfere with the study, such as tuberculosis, viral hepatitis, human immunodeficiency virus (HIV) infection, etc.\n* Special Condition: Subjects who cannot tolerate venipuncture or have a history of needle and blood sickness.\n* Organ Removal History: Subjects with surgical removal of the spleen or other vital organs for any reason.\n* Blood Condition: Subjects with blood loss (≥400 ml) and receipt of blood or blood products in the 3 months before receipt of the first dose of the investigational vaccine\n* Immune Therapy: Subjects received treatment with an immunosuppressive agent, such as long-term systemic glucocorticoid therapy (treatment with systemic glucocorticoids, such as prednisone or a similar agent, for more than 2 consecutive weeks within 6 months before receipt of the first dose of an investigational vaccine), except topical agents (such as ointments, eye drops, inhalers, or nasal sprays) that do not exceed the recommended dose in the label or have any signs of systemic exposure\n* Participation in Other Clinical Studies: Subjects use any investigational or unregistered product (drug, biologic product, or device) within 3 months before receipt of the first dose of the investigational vaccine, plan to use such product during the duration of this study, or were enrolled in another clinical trial before enrollment in this study.\n* Physical Examination: (a) Subjects with abnormal vital signs with clinical significance; (b) Subjects abnormal blood routine, blood biochemistry, and urine routine test indicators with clinical significance\n* Investigator's Discretion: The final exclusion criterion is the investigator's discretion to determine whether a subject is suitable for participation in the study.\n\nContraindications of the second and third doses of the vaccine:\n\nSubjects meeting any of the following contraindications will be not eligible for the following doses.\n\n* Serious Adverse Events: Subjects experienced serious adverse events related to vaccination after the previous dose.\n* Vaccination with other vaccines during the study: (a) Subjects received other diphtheria, Tetanus, and acellular pertussis combined vaccines except for the investigational vaccine after the previous dose during the study period; (b) Infants (C3 subgroup and D3 subgroup) received other polio vaccines after the previous dose during the study period.\n* Ineligibility: Subjects cannot be eligible or meet exclusion criteria after the previous dose of the investigational vaccine, and the qualification should be determined by the investigator.\n* Investigator's Discretion: Subjects determined by the investigator as unsuitable for the following study period.","2 Months",{"count":451,"type":20},460,[112],"This study is a randomized, blinded, active-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of the Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine (DTacP) in subjects (aged 2 months to 6 years). Primary safety endpoints are the occurrence of solicited adverse events within 30 minutes after each dose, the occurrence of solicited adverse events within 7 days after each dose, the occurrence of unsolicited adverse events within 30 days after each dose, and the occurrence of adverse events 30 days after immunization. The secondary safety endpoint is the occurrence of serious adverse events (SAEs) within 12 months after immunization. Secondary immunogenicity endpoints are the geometric mean concentration (GMC), geometric mean fold increase (GMFI), seropositive rates, seroconversion rates, or 4-fold increase rates of anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 30 days after immunization. The exploratory endpoints are the GMC, GMFI, seropositive rates, seroconversion rates, or 4-fold increase rates of anti-DT, anti-PT, and anti-FHA neutralizing antibodies 30 days after immunization in all groups, the GMC and seropositive rates of anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 12 months after primary immunization in the infant group, the seropositive rates and geometric mean tie (GMT) of anti- type I, type II, type III poliovirus neutralizing antibodies 30 days after immunization in all groups, the seropositive rates and geometric mean tie (GMT) of anti- type I, type II, type III poliovirus neutralizing antibodies 12 months after primary immunization in the infant group.",[81,26,80],"2024-01-01",{"date":457,"type":31},"2024-01-03",{"date":459,"type":31},"2023-12-23",{"date":461,"type":20},"2026-11-01",{"name":200,"class":100},3]