[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rabies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rabies":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,51,76,101,121,146],{"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":26,"conditions":27,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100619483","phase-2-safety-and-immunogenicity-of-id-vs-im-rabies-vaccine-100619483",false,"NCT07345208","Safety and Immunogenicity of ID vs IM Rabies Vaccine","An Open Label, Randomized Non-Inferiority Trial Comparing Safety and Immunogenicity of Intradermal Versus Intramuscular Administration of Registered Rabies Vaccine (by Popular Pharmaceuticals PLC.) in Healthy Bangladeshi Population","Inclusion Criteria:\n\n* Healthy volunteers aged \\>4 years\n* Able to comply with the research process and provide informed consent\n* Able to attend all the scheduled visits and comply with the trial procedures\n* Medical history and clinical examination demonstrating that the subject is healthy\n* Women willing to follow any method of contraception throughout the duration of the study.\n\nExclusion Criteria:\n\n* Subjects participating in other clinical trials in the 4 weeks preceding the first trial vaccination dose\n* Subjects with a history of previous rabies vaccination (either pre- or post-exposure prophylaxis)\n* Subjects with a history of receiving Rabies immunoglobulin (Ig (human\u002Fequine) prior to the study\n* Subjects with a fever (≥37.2°C) or any moderate or severe acute illnesses or active infections on the day of vaccination\n* History of systemic hypersensitivity to any component included in the vaccine or a history of adverse events as a reaction to previous experimental vaccine studies\n* History of receiving any immunoglobulin, blood, or blood-based product in the last 3 months or planning to donate blood in the following 3 months, which may interfere with the immune response\n* Screened as positive for HBsAg, Anti-HCV, and anti-HIV\n* Subjects receiving any vaccine at least 4 weeks prior to enrolment or expected to receive any vaccine 4 weeks after the administration of the trial vaccine.\n* Lactating women or pregnant women as detected by the urine hCG strip test.\n* History of alcohol or any substance abuse (benzodiazepines, methamphetamines, opioids, cannabinoids, cocaine, barbiturates) within 1 year\n* Subjects with congenital or acquired immunodeficiency or subjected to short- or long-term corticosteroid or immunosuppressive therapy\n* Thrombocytopenia, bleeding disorders, or anticoagulants used during the 3 weeks prior to trial vaccination to avoid intramuscular haemorrhage\n* Any major psychiatric disorder such as schizophrenia, major depressive disorder, severe anxiety disorder, etc.\n* History of cardiac arrhythmias, such as bradycardia, tachycardia, supraventricular tachycardia (SVT), ventricular tachycardia (VT), ventricular fibrillation (VF), atrial fibrillation (AF), etc., as assessed by the electrocardiogram report\n* History of renal insufficiency or dialysis\n* Any immunosuppressive disorder, such as cancers, multiple myeloma (MM), various autoimmune diseases, etc.\n* Participants with clinically significant or abnormal laboratory parameters (serum creatinine, SGPT, AST, serum electrolytes) in the opinion of the investigator.\n* Any condition that presents an unacceptable risk of injury, as assessed by the site investigator\n* Subjects planning to have surgery in the 3 months preceding the completion of the project\n* Subjects concurrently using anti-malarial drugs\n* Any condition that, in the researcher's opinion, would jeopardize the safety or rights of the subject or prevent the subject from completing the procedures of the study protocol\n* Subjects exposed to any rabid animal bite in the 4 weeks preceding the commencement of the study.\n* Subjects with Type I or Type II Diabetes, as assessed by Random Blood Sugar level.\n* All research facility staff directly participating in this study, including their immediate family and relatives.",true,"ALL","5 Years",{"count":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","Background:\n\nBurden: Rabies is a viral zoonotic disease that is 100% fatal if left untreated. Globally, Bangladesh is ranked third in terms of rabies infections. In 2009, the estimated human fatality from rabies in Bangladesh surpassed 2,000. However, the death toll has steadily declined to 26 in 2020, owing to the implementation of the 'National Rabies Elimination Program' beginning in 2010, which included the introduction of the cell culture vaccine. Though this infection is entirely preventable by vaccination, the available intramuscular regimen is costly and requires multiple high doses.\n\nKnowledge gap: The safety and immunogenicity of an intradermal rabies vaccine regimen in the Bangladeshi population needs to be assessed to comply with the recommendation of DGDA to obtain approval to be administered through an alternate route.\n\nRelevance: Intradermal rabies vaccine administration is a safe method that reduces the amount of vaccine needed and the number of doses required by producing immunogenicity similar to that of the intramuscular regimen. This translates to 60-80% cost reductions while preserving the safety and immunogenicity of the vaccine. The intramuscular rabies vaccine by Popular Pharmaceuticals PLC has already been granted marketing authorization by DGDA. However, the vaccine's administration via the intradermal route is yet to receive approval from DGDA for marketing as per the regulatory requirements.\n\nHypothesis: The immunogenicity and safety of the Intradermal rabies vaccine (Popular Pharmaceutical PLC) will be non-inferior to the intramuscular regimen of the same vaccine.\n\nObjectives:\n\n1. To compare the seroconversion level of the intradermal rabies vaccine to the intramuscular regimen by Popular Pharmaceuticals PLC. in healthy Bangladeshi individuals\n2. To compare the safety of the intradermal rabies vaccine to the intramuscular regimen by Popular Pharmaceuticals PLC. in healthy Bangladeshi individuals\n\nMethods: This will be an open-label, non-inferiority, single-blinded, randomized controlled trial where the safety and immunogenicity of the intradermal rabies vaccine will be assessed compared with the standard intramuscular regimen, both by Popular Pharmaceuticals PLC., amongst healthy individuals. The study will be conducted at the Infectious Disease and Tropical Medicine Department (Surya Kanta Hospital), Mymensingh Medical College Hospital, Mymensingh. We will enroll 90 participants and randomly assign them to two equal groups: a test group and a reference group. The test groups will receive 0.2 ml Inj. Rabivax intradermally (0.1 ml in each arm), whereas the reference group will receive 1 ml Injectable Rabivax (2.5 IU\u002Fml) intramuscularly. The participants will be followed up on days 21, 35, and 187 for clinical and biochemical evaluation. A comparative analysis of safety and immunogenicity will be conducted on intradermal and intramuscular administration based on the collected data.\n\nOutcome measures\u002Fvariables:\n\n* A seroconversion level of 0.5 IU\u002Fml or more when tested for Rabies Virus Neutralizing Antibody (RVNA) following intradermal vaccination by Popular Pharmaceuticals PLC. during the study period\n* Non-inferior safety parameters of the intradermal rabies vaccine regimen in comparison with the available intramuscular regimen by Popular Pharmaceuticals PLC.",[28],"Rabies",[30,31,32,33,34,35,36,37],"pre-exposure prophylaxis","intradermal","rabies vaccine","clinical trial","intramuscular","safety","immunogenicity","non-inferiority","NOT_YET_RECRUITING","2026-01-06",{"date":41,"type":42},"2026-01-15","ACTUAL",{"date":44,"type":21},"2025-12-15",{"date":46,"type":21},"2027-07-15",{"name":48,"class":49},"International Centre for Diarrhoeal Disease Research, Bangladesh","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":16,"sex":17,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":50},"100605860","phase-2-safety-and-immunogenicity-of-coadministration-of-the-candidate-rabies-vaccine-chadox2-rabg-and-licensed-vaccine-100605860","NCT07168018","Safety and Immunogenicity of Coadministration of the Candidate Rabies Vaccine ChAdOx2 RabG and Licensed Vaccine","A Phase II Randomised, Open-label Study of the Safety and Immunogenicity of Coadministration of the Candidate Rabies Vaccine ChAdOx2 RabG and Licensed Vaccine","Inclusion Criteria:\n\n* Healthy male or female adults aged 18-45 years at the time of enrolment with signed consent.\n* (Female only participants): Must be non-pregnant (as demonstrated by a negative serum pregnancy test) and willing to use an effective form of contraception.\n\n  \\*Female volunteers are required to use an effective form of contraception during the course of the study. There is currently no information about the effect of this vaccine on a foetus. Acceptable forms of contraception for female volunteers include:\n* Established use of injected or implanted hormonal methods of contraception.\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS).\n* Total abdominal hysterectomy.\n* Planned long-term (at least 2 months from the date of the first vaccination) or permanent residence in Bagamoyo town.\n* Adults with a Body Mass Index (BMI) 18 to 30 Kg\u002Fm2\n* Correctly answer all 10 questions on the protocol and study procedures understanding questionnaire within 2 attempts.\n\nExclusion Criteria:\n\n* Clinically significant congenital abnormalities as judged by the PI or other delegated individual.\n* Clinically significant history of skin disorder, allergy, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease and neurological illness which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data as judged by the PI or other delegated individual.\n* Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed).\n* History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including IRVs e.g. amphotericin B, chlortetracycline, neomycin, polymyxin, streptomycin\n* Any history of anaphylaxis in relation to vaccination.\n* Clinically significant laboratory abnormality as judged by the PI or other delegated individual.\n* Receipt of any previous rabies vaccinations, including an incomplete course of IRV and\u002For any doses of ChAdOx2 RabG.\n* History of vaccination with previous adenoviral vectored vaccines in the 6 months prior to enrolment in the study, or of vaccination with any other vaccine (including non-adenovirus-vectored COVID-19 vaccines) in the 28 days prior to enrolment.\n* Planned \u002F likely receipt of any other vaccine within 28 days after enrolment.\n* History of bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture, or continuous anticoagulation e.g., with warfarin\n* History of confirmed major thrombotic event, (including cerebral venous sinus thrombosis, deep vein thrombosis, pulmonary embolism) or,\n* History of antiphospholipid syndrome.\n* History of prior receipt of unfractionated heparin\n* History of heparin induced thrombocytopenia\n* Receipt of any blood products\u002F immunoglobulins within the three months preceding the planned administration of the vaccine candidate.\n* Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period.\n* Seropositive for hepatitis B surface antigen (HBsAg) or hepatitis C (HCV IgG).\n* Likelihood of travel away from the study area.\n* Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.\n* Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.\n* Any other significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.\n* Contraindication to use of paracetamol","18 Years","45 Years",{"count":61,"type":21},40,[24],"This is a phase II randomised, open-label study to assess the safety and immunogenicity of coadministration of the candidate rabies vaccine ChAdOx2 RabG and licensed vaccine in healthy adults (18-45 years old). ChAdOx2 RabG will be administered intramuscularly and licensed rabies vaccine will be given either intramuscularly (i.e., for the intervention group) or by intradermal injection (i.e., for the control group).",[28],[66],"Vaccine","2025-11-14",{"date":69,"type":42},"2025-11-18",{"date":71,"type":21},"2025-12",{"date":73,"type":21},"2026-03",{"name":75,"class":49},"University of Oxford",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":16,"sex":17,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":50},"100597192","phase-3-immunogenicity-and-safety-of-rabies-vaccine-serum-free-vero-cell-in-a-pre-exposure-prophylaxis-regimen-100597192","NCT07055295","Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Pre-exposure Prophylaxis Regimen","Immunogenicity and Safety of a Rabies Vaccine (Serum-free Vero Cell), Freeze-dried in Comparison With Verorab®, in a Pre-exposure Prophylaxis Regimen in Healthy Populations Aged ≥1 Years: A Randomized, Double-Blind, Active-controlled Phase Ⅲ Clinical Trial","Inclusion Criteria:\n\n1. Populations aged ≥1 years old;\n2. Participants and\u002For participants' parents\u002Flegal guardians are able to understand and sign the informed consent form (ICF) voluntarily;\n3. Participants are able to comply with the study procedures based on the investigator's assessment;\n4. In a stable health status (defined as a stable preexisting disease status during the past 3 months, i.e., no change in treatment or hospitalization due to exacerbation of preexisting diseases);\n5. Participants were tested negative for HIV, Syphilis, Hepatitis B, Hepatitis C infection at the screening of this study (the test result should be provided)\n6. Female participants aged ≥15 years old with childbearing potential were tested negative for urine pregnancy test pre-vaccination, and also need to have effective contraceptive measures in the previous 2 weeks pre-vaccination;\n7. Participants of childbearing potential and their partners are willing to take effective contraceptive measures and have no sperm or ovum donation plan from the time of signing ICF to 28 days after the last dose of vaccination;\n8. Participants should provide verifiable identifications, and contact or be contacted with the investigators during the study period\n\nExclusion Criteria:\n\n1. Fever on vaccination day, with axillary temperature \\>37.0°C (aged ≥5years old) or \\>37.3°C (aged 1\\~4 years old) pre-vaccination;\n2. Previous vaccination against rabies (in pre- or post-exposure regimen) with either trial vaccines or licensed vaccines;\n3. Previous administration with rabies immunoglobulins or monoclonal antibodies;\n4. Bite by, or exposure to a potentially rabid animal in the previous 12 months with category Ⅱ or Ⅲ exposures;\n5. Female participants who are currently lactating or pregnant;\n6. Known serious allergy to vaccines or vaccine ingredients, such as severe urticaria, anaphylactic shock, allergic laryngeal edema, allergic purpura, or known other serious adverse reactions to vaccine;\n7. With severe congenital malformations or developmental disorders, genetic defects, severe malnutrition;\n8. With autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);\n9. With poor controlled chronic illnesses or history of severe diseases, including but not limited to cardiovascular diseases, hematological disorders, liver and kidney diseases, digestive system disorders, respiratory diseases, malignancies, a history of major organ transplantation, drug-uncontrolled hypertension (only for participants aged ≥18 years old: with systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg), or any other disease or medical condition that the investigator believes could interfere with the trial results;\n10. With current or past history of severe neurological diseases (epilepsy, convulsions or seizures \\[excluding history of febrile seizures\\]) or psychiatric disorders, or presence of a family history of psychiatric disorders;\n11. With coagulation disorders (eg. factor deficiency, platelet disorders), or history of bleeding, hematoma, or bruising following intramuscular injections or venipuncture;\n12. Receipt of ≥14 days of immunosuppressive or other immunomodulatory therapy (prednisone ≥2mg\u002Fkg\u002Fday, or its equivalent), cytotoxic therapy within 180 days prior to screening, or plans for such treatment in this study;\n13. With long-term alcohol abuse \\[\\>14 drinks per week (1 drink =14 g 100% alcohol =360 mL beer, or 150 mL wine, or 45 mL distilled liquor\u002Fliquor)\\] or substance abuse (repeated and heavy use of narcotic drugs, psychotropic drugs, volatile organic solvents, etc.)\n14. Receipt of blood products or immunoglobulins within 180 days prior to screening, or plans to receive these treatments in the study;\n15. Receipt of other investigational drugs\u002Fvaccines within 30 days prior to screening, or plans to receive such drugs or vaccines during the study period;\n16. Currently participating in other vaccine or drug clinical trials, or plan to participate in other clinical trials during the study;\n17. Receipt of live-attenuated vaccines within 14 days prior to screening, or subunit or inactivated vaccines within 7 days prior to screening;\n18. Presence of skin injuries, inflammation, ulcers, rashes, scars, or other conditions at the intended vaccination site that may interfere with drug administration or observation of local reactions;\n19. Acute onset of various acute diseases or chronic diseases within the past 7 days, or known or suspected active infections;\n20. Any other factors considered by the investigator to make the participant unsuitable for participation in the study","1 Year",{"count":85,"type":21},390,[25],"To demonstrate the immunogenicity of Sinovac rabies vaccine is non-inferior to the active-controlled rabies vaccine (Verorab®) after pre-exposure prophylaxis (PrEP) vaccination, and to confirm its satisfying safety profile in the pediatric and adult population in a PrEP schedule",[28],[32,90,30],"Serum-free","2025-06-27",{"date":93,"type":42},"2025-07-08",{"date":95,"type":21},"2026-03-01",{"date":97,"type":21},"2026-12-30",{"name":99,"class":100},"Sinovac Biotech Co., Ltd","INDUSTRY",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":16,"sex":17,"minAge":58,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":120,"locationsCount":50},"100597237","phase-2-immunogenicity-and-safety-of-different-dosages-of-rabies-vaccine-serum-free-vero-cell-100597237","NCT07055880","Immunogenicity and Safety of Different Dosages of Rabies Vaccine (Serum-free Vero Cell)","Immunogenicity and Safety of Two Dosages of Rabies Vaccine (Serum-free Vero Cell), Freeze-dried in Comparison With Verorab®, in a Simulated Post-exposure Prophylaxis Regimen in Healthy Adults: A Randomized, Double-Blind, Active-controlled Phase Ⅱ Clinical Trial","Inclusion Criteria:\n\n1. Populations aged 18\\~59 years old;\n2. Participants are able to understand and sign the informed consent form (ICF) voluntarily;\n3. Participants are able to comply with the study procedures based on the investigator's assessment;\n4. In a stable health status (defined as a stable preexisting disease status during the past 3 months, i.e., no change in treatment or hospitalization due to exacerbation of preexisting diseases);\n5. Participant was tested negative for HIV, Syphilis, Hepatitis B, Hepatitis C infection at the screening of this study (the test result should be provided);\n6. Female participants of childbearing potential were tested negative for urine pregnancy test pre-vaccination, and also need to have effective contraceptive measures in the previous 2 weeks pre-vaccination;\n7. Participants of childbearing potential and their partners are willing to take effective contraceptive measures and have no sperm or ovum donation plan from the time of signing ICF to 28 days after the last dose of vaccination;\n8. Participants should provide verifiable identifications, and contact or be contacted with the investigators during the study period.\n\nExclusion Criteria:\n\n1. Fever on vaccination day, with axillary temperature \\>37.0°C pre-vaccination;\n2. Previous vaccination against rabies (in pre- or post-exposure regimen) with either trial vaccines or licensed vaccines;\n3. Previous administration with rabies immunoglobulins or monoclonal antibodies;\n4. Bite by, or exposure to a potentially rabid animal in the previous 12 months with category Ⅱ or Ⅲ exposures;\n5. Female participants who are currently lactating or pregnant;\n6. Known serious allergy to vaccines or vaccine ingredients, such as severe urticaria, anaphylactic shock, allergic laryngeal edema, allergic purpura, or known other serious adverse reactions to vaccine;\n7. With severe congenital malformations or developmental disorders, genetic defects, severe malnutrition;\n8. With autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);\n9. With poor controlled chronic illnesses or history of severe diseases, including but not limited to cardiovascular diseases, hematological disorders, liver and kidney diseases, digestive system disorders, respiratory diseases, malignancies, a history of major organ transplantation, drug-uncontrolled hypertension (with systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg), or any other disease or medical condition that the investigator believes could interfere with the trial results;\n10. With current or past history of severe neurological diseases (epilepsy, convulsions or seizures \\[excluding history of febrile seizures\\]) or psychiatric disorders, or presence of a family history of psychiatric disorders;\n11. With coagulation disorders (eg. factor deficiency, platelet disorders), or history of bleeding, hematoma, or bruising following intramuscular injections or venipuncture;\n12. Receipt of ≥14 days of immunosuppressive or other immunomodulatory therapy (prednisone ≥2mg\u002Fkg\u002Fday, or its equivalent), cytotoxic therapy within 180 days prior to screening, or plans for such treatment in this study;\n13. With long-term alcohol abuse \\[\\>14 drinks per week (1 drink =14 g 100% alcohol =360 mL beer, or 150 mL wine, or 45 mL distilled liquor\u002Fliquor)\\] or substance abuse (repeated and heavy use of narcotic drugs, psychotropic drugs, volatile organic solvents, etc.)\n14. Receipt of blood products or immunoglobulins within 180 days prior to screening, or plans to receive these treatments in the study;\n15. Receipt of other investigational drugs\u002Fvaccines within 30 days prior to screening, or plans to receive such drugs or vaccines during the study period;\n16. Currently participating in other vaccine or drug clinical trials, or plan to participate in other clinical trials during the study;\n17. Receipt of live-attenuated vaccines within 14 days prior to screening, or subunit or inactivated vaccines within 7 days prior to screening;\n18. Presence of skin injuries, inflammation, ulcers, rashes, scars, or other conditions at the intended vaccination site that may interfere with drug administration or observation of local reactions;\n19. Acute onset of various acute diseases or chronic diseases within the past 7 days, or known or suspected active infections;\n20. Any other factors considered by the investigator to make the participant unsuitable for participation in the study","59 Years",{"count":110,"type":21},120,[24],"To describe the immunogenicity and safety of two dosages of Sinovac rabies vaccine, as well as compared the differences with the marked WHO PQ rabies vaccine Verorab® in a post-exposure prophylaxis (PEP) schedule.",[28],[32,90],{"date":116,"type":42},"2025-07-09",{"date":118,"type":21},"2025-07-28",{"date":41,"type":21},{"name":99,"class":100},{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":16,"sex":17,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":50},"100594611","phase-1-a-clinical-trial-of-rabies-vaccinehuman-diploid-cellfor-human-usefreeze-dried-100594611","NCT07021703","A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried","A Open-label, Randomized Study to Evaluate the Safety and Tolerability of Freeze-dried Human Rabies Vaccine (Human Diploid Cells) Administered to Participants With Different Immunization Schedules","Inclusion Criteria:\n\n* (1) The participants' ages range from 10 to 60 years old (≥10 years old and \\\u003C61 years old).\n\n  (2) Participants aged 10 to 17 and their guardians can provide valid identification documents, and participants aged 18 to 60 can provide their own valid identification documents.\n\n  (3) Participants aged 10 to 17 and their guardians, as well as participants aged 18 to 60, can sign the informed consent form voluntarily to participate in the trial, fully understand the trial procedures, the risks of participating in the trial, and other intervention measures that can be chosen if they do not participate in the trial, etc.\n\n  (4) Possess basic reading and writing skills, and be capable of reading, understanding and filling in diary cards and contact cards; (5) Female participants with fertility must also meet the following conditions: 1) They have taken effective contraceptive measures within two weeks prior to participating in this trial; 2) Have no plans to have children within 6 months from the start of participating in this trial until the full vaccination. 3) Understand and agree to take effective contraceptive measures during the trial period (from the first dose to within 6 months after the full vaccination). Effective contraceptive measures include: condoms (for men), intrauterine devices, oral contraceptives (excluding emergency contraceptives), sterilization, abstention, injection or implantable contraception, sustained-release local contraceptives, hormone patches, diaphragms, cervical caps, etc. External ejaculation and safe period contraception are not regarded as effective contraceptive measures.\n\nExclusion Criteria:\n\n* For the standards marked with \\*, if the participants have the circumstances stipulated in the standard, the visit can be rescheduled when they no longer have these circumstances\n\n  1. After inquiry, it is found that there is a history of rabies vaccination or the use of passive immunization preparations for rabies virus.\n  2. There was a history of injury from rabies virus-susceptible animals (such as cats and dogs) before the first dose of vaccination;\n  3. The axillary body temperature of the participants on the day of enrollment was ≥37.3℃\\*;\n  4. Those whose various examination results during the screening period are abnormal and are determined by clinicians to be of clinical significance;\n  5. Women who have a positive urine pregnancy test before vaccination (on the day of vaccination), or who, after assessment, cannot rule out the possibility of pregnancy or are breastfeeding;\n  6. Hypertension that cannot be controlled by medication, such as systolic blood pressure ≥140mmHg and\u002For diastolic blood pressure ≥90mmHg for participants aged 18 years and above before enrollment;\n  7. Allergy to any component of the vaccine used in the test, such as human albumin, sucrose, or maltose;\n  8. Those with a history of severe allergies in the past, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, local allergic necrosis reaction (Arthus reaction), severe urticaria, allergic bronchitis, acquired angioedema, etc.\n  9. Has been diagnosed with congenital or acquired immune system diseases Such as Human Immunodeficiency Virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease or other immune diseases that researchers determine may affect the evaluation of the trial;\n  10. Known or suspected of having serious diseases, including severe respiratory diseases, liver and kidney diseases, cardiovascular and cerebrovascular diseases, malignant tumors, and other chronic diseases that are poorly controlled, etc.\n  11. Abnormal coagulation function (such as deficiency of coagulation factors, coagulation disorders, abnormal platelets) or coagulation disorders diagnosed by a doctor;\n  12. Anplenia or functional anplenia, as well as anplenia or splenectomy caused by any circumstances;\n  13. Previous or current clearly diagnosed neurological or mental disorders (including but not limited to dementia, schizophrenia, bipolar disorder, etc.) or confirmed epilepsy, convulsions, as well as other neurological or mental disorders that the researcher deems unsuitable for participation in this trial;\n  14. It is planned to receive such treatment within 30 days after the first dose of vaccination and the full course of vaccination, such as long-term systemic glucocorticoid therapy (used continuously for 2 weeks or more, at a dose of 2mg\u002Fkg\u002F day or 20mg\u002F day prednisone or an equivalent dose); Local medications (such as ointments, eye drops, inhalants or nasal sprays) are allowed;\n  15. Have received or plan to receive immunoenhancers or inhibitors, immunoglobulins or blood-related products throughout the trial period within 3 months prior to enrollment;\n  16. Have received attenuated live vaccines within 14 days before enrollment, and subunit vaccines or inactivated vaccines within 7 days \\*;\n  17. Within 3 days before enrollment, have suffered from acute diseases or be in the acute attack stage of chronic diseases \\*;\n  18. Antipyretic, analgesic and antihistamine drugs were used within 3 days before enrollment.\n  19. Currently participating in or planning to participate in other clinical trials during this clinical trial;\n  20. According to the researcher's judgment, due to various medical, psychological, social conditions or other circumstances contrary to the trial protocol, or the participants' inability to comply with the requirements of the trial protocol.","10 Years","60 Years",{"count":131,"type":21},60,[133],"PHASE1","The Phase 1 clinical trial of the freeze-dried human rabies vaccine (human diploid cells) will be conducted on participants aged 10 to 60. This study will design a single-arm, randomized, open-access trial with different immunization schedules (5-dose schedule and 2-1-1 schedule) to evaluate the safety and tolerability of the vaccine in participants aged 10 to 60",[28],"RECRUITING","2025-06-11",{"date":139,"type":42},"2025-06-15",{"date":141,"type":42},"2025-05-23",{"date":143,"type":21},"2025-12-31",{"name":145,"class":100},"Ningbo Rongan Biological Pharmaceutical Co., Ltd.",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":16,"sex":17,"minAge":128,"maxAge":129,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":50},"100595157","phase-3-clinical-trial-of-freeze-dried-human-rabies-vaccine-human-diploid-cells-100595157","NCT07028801","Clinical Trial of Freeze-dried Human Rabies Vaccine (Human Diploid Cells)","A Randomized, Blinded, Parallel Controlled, Non-inferiority Design Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (Human Diploid Cells) Administered to Participants Aged 10 to 60 Years With Different Immunization Schedules","Inclusion Criteria:\n\n* (1) The participants' ages range from 10 to 60 years old (≥10 years old and \\\u003C61 years old).\n\n  (2) Participants aged 10 to 17 and their guardians can provide valid identification documents, and participants aged 18 to 60 can provide their own valid identification documents.\n\n  (3) Participants aged 10 to 17 and their guardians, as well as participants aged 18 to 60, can sign the informed consent form voluntarily to participate in the trial, fully understand the trial procedures, the risks of participating in the trial, and other intervention measures that can be chosen if they do not participate in the trial, etc.\n\n  (4) Possess basic reading and writing skills, and be capable of reading, understanding and filling in diary cards and contact cards; (5) Female participants with fertility must also meet the following conditions: 1) They have taken effective contraceptive measures within two weeks prior to participating in this trial; 2) Have no plans to have children within 6 months from the start of participating in this trial until the full vaccination. 3) Understand and agree to take effective contraceptive measures during the trial period (from the first dose to within 6 months after the full vaccination). Effective contraceptive measures include: condoms (for men), intrauterine devices, oral contraceptives (excluding emergency contraceptives), sterilization, abstention, injection or implantable contraception, sustained-release local contraceptives, hormone patches, diaphragms, cervical caps, etc. External ejaculation and safe period contraception are not regarded as effective contraceptive measures.\n\nExclusion Criteria:\n\n* For the standards marked with \\*, if the participants have the circumstances stipulated in the standard, the visit can be rescheduled when they no longer have these circumstances\n\n  1. After inquiry, it is found that there is a history of rabies vaccination or the use of passive immunization preparations for rabies virus.\n  2. There was a history of injury from rabies virus-susceptible animals (such as cats and dogs) before the first dose of vaccination;\n  3. The axillary body temperature of the participants on the day of enrollment was ≥37.3℃\\*;\n  4. Women who have a positive urine pregnancy trial before vaccination (on the day of vaccination), or who, after assessment, cannot rule out the possibility of pregnancy or are breastfeeding;\n  5. Hypertension that cannot be controlled by medication, such as systolic blood pressure ≥160mmHg and\u002For diastolic blood pressure ≥100mmHg for participants aged 18 years and above before enrollment;\n  6. Allergy to any component of the vaccine used in the trial, such as human albumin, sucrose, or maltose;\n  7. Those with a history of severe allergies in the past, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, local allergic necrosis reaction (Arthus reaction), severe urticaria, allergic bronchitis, acquired angioedema, etc.\n  8. Has been diagnosed with congenital or acquired immune system diseases, such as the Human Immunodeficiency Virus. HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease or other immune diseases that the researcher deems likely to affect the trial assessment;\n  9. Known or suspected of having serious diseases, including severe respiratory diseases, liver and kidney diseases, cardiovascular and cerebrovascular diseases, malignant tumors, and other chronic diseases that are poorly controlled, etc.\n  10. Abnormal coagulation function (such as deficiency of coagulation factors, coagulation disorders, abnormal platelets) or coagulation disorders diagnosed by a doctor;\n  11. Anplenia or functional anplenia, as well as anplenia or splenectomy caused by any circumstances;\n  12. Previous or current clearly diagnosed neurological or mental disorders (including but not limited to dementia, schizophrenia, bipolar disorder, etc.) or confirmed epilepsy, convulsions, as well as other neurological or mental disorders that the researcher deems unsuitable for participation in this trial;\n  13. It is planned to receive such treatment from the first dose of vaccination to 30 days after the full vaccination course, such as long-term systemic glucocorticoid therapy (used continuously for 2 weeks or more, at a dose of ³2mg\u002Fkg\u002F day or ³20mg\u002F day prednisone or equivalent doses); Local medications (such as ointments, eye drops, inhalants or nasal sprays) are allowed;\n  14. Have received or plan to receive immunoenhancers or inhibitors, immunoglobulins or blood-related products throughout the trial period within 3 months prior to enrollment;\n  15. Have received attenuated live vaccines within 14 days before enrollment, and subunit vaccines or inactivated vaccines within 7 days \\*;\n  16. Within 3 days before enrollment, have suffered from acute diseases or be in the acute attack stage of chronic diseases \\*;\n  17. Antipyretic, analgesic and antihistamine drugs were used within 3 days before enrollment.\n  18. Currently participating in or planning to participate in other clinical trials during this clinical trial;\n  19. According to the researcher's judgment, due to various medical, psychological, social conditions or other circumstances contrary to the trial protocol, or the participants' inability to comply with the requirements of the trial protocol.",{"count":154,"type":21},3000,[25],"The Phase 3 clinical trial of freeze-dried human rabies vaccine (human diploid cells) adopted a randomized, blinded, parallel control,non-inferiority design,and administered vaccines to participants aged 10 to 60 years with different immunization schedules (5-dose schedule group, two simple 4-dose schedule groups, and 2-1-1 schedule group) to evaluate the immunogenicity and safety of the vaccine.",[28],{"date":159,"type":42},"2025-06-19",{"date":161,"type":21},"2025-07-31",{"date":163,"type":21},"2026-03-31",{"name":145,"class":100}]