[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Institute of Medical Biology, Chinese Academy of Medical Sciences\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":191},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,46,71,97,125,147,173],{"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":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100625110","phase-1-phase-iii-clinical-trial-of-diphtheria-tetanus-pertussis-reduced-dose-vaccine-100625110",false,"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.",true,"ALL","6 Years",{"count":20,"type":21},660,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","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.",[28,29,30,31,32],"Tetanus, Diphtheria and Acellular Pertussis Vaccination","Tetanus","Diphtheria","Pertussis","Pertussis Vaccines","NOT_YET_RECRUITING","2026-02-11",{"date":36,"type":37},"2026-02-18","ACTUAL",{"date":39,"type":21},"2026-03-12",{"date":41,"type":21},"2027-07-31",{"name":43,"class":44},"Institute of Medical Biology, Chinese Academy of Medical Sciences","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":16,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":45},"100618073","phase-1-phase-i-clinical-trial-of-enterovirus-type71---coxsackievirus-type-a16-bivalent-vaccine-100618073","NCT07326878","Phase I Clinical Trial of Enterovirus Type71 - Coxsackievirus Type A16 Bivalent Vaccine","A Single-center, Randomized, Double-blind, and Placebo Controlled Phase Ⅰ Clinical Trial of the Safety and Preliminary Immunogenicity of Enterovirus Type71 - Coxsackievirus Type A16 Bivalent Vaccine in People Aged 6 Months to 59 Years","Inclusion Criteria:\n\n* Age Requirement: volunteers aged 6 months and 59 years.\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* 6\\~23months old: term delivery (gestational week 37 weeks \\~ 42 weeks at birth), 2500g ≤ birth weight ≤ 4000g.\n* Requirements for contraception: agree to take contraception actions in 12 months.\n* Temperature Requirement: axillary body temperature is less than 37.3°C.\n\nExclusion Criteria:\n\nSubjects meeting any of the following exclusion criteria will be not eligible for enrollment.\n\n* Subjects who have been allergic to any component of the vaccine in the past, or have any history of vaccine allergy or suspected allergy or other serious adverse reactions, such as urticaria, respiratory distress, and angioedema.\n* History of taking administration of a non-SARS-CoV-2 inactivated vaccine or subunit vaccine within 7 days before enrollment, or any live attenuated vaccine or SARS-CoV-2 vaccine within 14 days before enrollment.\n* Subjects with convulsion, epilepsy, encephalopathy, psychiatric history or family history.\n* Known to have serious congenital malformations, developmental disorders, genetic defects or abnormal growth and development, or clinically diagnosed serious chronic diseases, including but not limited to neurological, cardiovascular, blood and lymphatic system, immune system, kidney, liver, gastrointestinal, respiratory system, metabolism and bone diseases and a history of malignant tumors.\n* Subjects are acutely ill or in the acute phase of a chronic illness within 3 days before vaccination.\n* Subjects with a hereditary bleeding tendency or coagulopathy, or a history of bleeding disorders.\n* Subjects who intolerance to venipuncture and with a history of needle- or blood-induced syncope.\n* History of surgical removal of the spleen or other vital organs for any reason.\n* Donation or loss of blood (≥400 mL), receipt of blood products, or receipt of blood transfusion within the 3 months before enrollment.\n* Use of any investigational or unregistered product (drug, vaccine, biological product, or device) other than a study vaccine within 3 months before enrollment or planned for use during the study.\n* Have treatment with immunosuppressive agents within 6 months before enrollment, such as long-term systemic glucocorticoid therapy (e.g., prednisone or a similar drug for more than 2 consecutive weeks within 6 months), but topical use (e.g., ointments, eye drops, inhalers, or nasal sprays) was allowed. Topical use should not exceed the recommended dose on the label or have any signs of systemic exposure.\n* History of any EV71 antigen-containing vaccination, whether commercially available or investigational.\n* Subjects with history of hand, foot, and mouth disease.\n* Subjects with abnormal vital signs with clinical significance.\n* Subjects who do not meet the criteria for good health based on comprehensive physical examination, including: (1) abnormal vital signs with clinical significance; (2) clinical laboratory testing shows laboratory abnormalities and with clinical significance (applicable only to subjects aged 2 years and above).\n* Have been diagnosed with an infectious disease that may interfere with the conduct or completion of the study, such as active tuberculosis, viral hepatitis, human immunodeficiency virus (HIV) infection, etc.\n* Females with positive pregnancy test results.\n* Females who are lactating, or subjects who plan to conceive or to donate sperm or ova from the time of signing the informed consent form until 12 months after completion of the full vaccination schedule (applicable only to subjects aged 18 to 59 years).\n* Subjects with a history of abnormal birth delivery, birth asphyxia, neurological impairment, or clinically diagnosed pathological jaundice (applicable only to subjects aged 6 to 23 months).\n* Subjects deemed by the investigator to be unsuitable for participation in the study.","6 Months","59 Years",{"count":56,"type":21},144,[24],"This is a randomized, double-blinded, placebo-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of the Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine in subjects ( aged 6 months to 59 years ).",[60,61,62],"Hand, Foot and Mouth Disease (HFMD)","HFMD","Hand, Foot and Mouth Disease","2025-12-26",{"date":65,"type":37},"2026-01-08",{"date":67,"type":21},"2025-12-30",{"date":69,"type":21},"2027-08-15",{"name":43,"class":44},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":16,"sex":17,"minAge":78,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100586798","phase-4-study-of-concomitant-administration-of-the-sipv-and-dtap-or-mmr-100586798","NCT06920069","Study of Concomitant Administration of the sIPV and DTaP or MMR","Phase IV Study of Evaluating Immunogenicity and Safety of Concomitant Administration of Sabin-strain-based Inactivated Poliovirus Vaccine (Vero Cells) and Adsorbed Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine or Measles, Mumps and Rubella Combined Live-attenuated Vaccine","Inclusion Criteria:\n\n* Age Requirement: Infants aged 2 months at the time of enrollment\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, and sign the informed consent form.\n* Adherence: Legal guardians or appointed representatives of volunteers must be able to comply with the requirements in the study as well as complete relevant visits on time.\n* Birth Condition: Full-term at birth (gestational age ≥ 37 weeks and \\\u003C 42 weeks) and birth weight ≥ 2500g\n\nExclusion Criteria:\n\n* Vaccination History: received vaccines containing diphtheria-tetanus-pertussis antigens, polio antigens, Hib conjugate vaccine, or 13-valent pneumococcal conjugate vaccine before enrollment.\n* Those who had received blood transfusions or used blood products (except hepatitis B immunoglobulin) before enrollment.\n* Recent Vaccination: Volunteers received any inactivated vaccines or subunit vaccines within 7 days (including the 7th day) prior to vaccination with the investigational vaccine, or any other live attenuated vaccines within 14 days (including the 14th day) prior to vaccination.\n* Acute Illness: Volunteers have experienced acute illnesses (e.g., fever) within 3 days before enrollment, or have used antipyretic analgesics or antihistamines within 3 days.\n* Allergic History: Volunteers who are allergic to any component of sIPV, bOPV, DTaP, or MMR, or who are allergic to kanamycin sulfate, kanamycin, or gentamicin sulfate, or those with an allergic constitution.\n* Birth Condition: Severe neonatal diseases caused by abnormal delivery and other reasons, such as birth trauma, neonatal asphyxia, respiratory distress syndrome, neonatal intracranial hemorrhage, etc., or patients with clinically confirmed severe hyperbilirubinemia.\n* Neurological and Mental Health: Volunteers with encephalopathy, convulsions, epilepsy, or other progressive neurological disorders, or those whose families have a history of genetic predisposition to convulsions or epilepsy, or a history of genetic predisposition to mental illness.\n* History of Related Illness: Volunteers who have a history of poliomyelitis, pertussis, diphtheria, tetanus, measles, rubella, or mumps.\n* Immune Therapy: Volunteers with immunodeficiency, weakened immune function, or those who have received immunosuppressive therapy (such as long-term systemic glucocorticoid treatment, but excluding local medications like inhalants or nasal sprays).\n* Other Diseases: Volunteers with severe diseases, encompassing those in the cardiovascular system, blood and lymphatic systems, immune system, kidneys, liver, gastrointestinal tract, respiratory system, metabolism, and bones, etc.\n* Participation in Other Clinical Studies: Volunteers are currently or have plans to participate in other clinical studies before enrollment.\n* Investigator's Discretion: The final exclusion criterion is the investigator's discretion to determine whether a volunteer is suitable for participation in the study.","2 Months",{"count":80,"type":21},2640,[82],"PHASE4","This study is a randomized, open-labeled phase IV clinical trial to evaluate the immunogenicity and safety of concomitant administration of sIPV and DTaP or MMR in infants aged 2 months. Primary immunogenicity endpoints in all groups include the seroconversion rate of type I, II, and III anti-poliovirus neutralizing antibodies, anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 30 days after basic immunization. Secondary immunogenicity endpoints include the seropositive rates, seroconversion rates, geometric mean titer\u002Fconcentration (GMT\u002FGMC), geometric mean fold increase (GMFI) of type I, II, and III anti-poliovirus neutralizing antibodies, anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies, and anti-measles, anti-mumps, and anti-rubella antibodies 30 days after full immunization. The secondary safety endpoints are the incidence of adverse events (AEs) within 30 minutes after each injection, the incidence of solicited local and systematic AEs in the period of solicitation after each injection, the incidence of unsolicited AEs in 30 days after each injection, the incidence of AEs in 30 days after each injection, and the incidence of serious adverse events in 6 months after administrations.",[85,86,87],"Polio","Diphteria, Tetanus and Pertussis","MMR Vaccine","2025-04-14",{"date":90,"type":37},"2025-04-17",{"date":92,"type":21},"2025-05-15",{"date":94,"type":21},"2031-06-15",{"name":43,"class":44},9,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":16,"sex":17,"minAge":104,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},"100577642","phase-3-phase-iii-clinical-trial-of-quadrivalent-influenza-virus-split-vaccine-100577642","NCT06800950","Phase III Clinical Trial of Quadrivalent Influenza Virus Split Vaccine","A Randomized, Blinded, Positive-controlled Phase III Clinical Trial of Quadrivalent Influenza Vaccine (split Virion) in People Aged 3 Years and Above","Inclusion Criteria:\n\n* Age Requirement: volunteers aged 3 years and above at the time of enrollment.\n* Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.\n* Informed Consent: Volutters, 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* Requirements for contraception: agree to take contraception actions in 6 months.\n* Temperature Requirement: Axillary body temperature is less than 37.3°C.\n* Previous Vaccination Requirements: (a) Received at least 1 dose of influenza vaccine within 1 year before screening in children aged 3-8 years; (b) Never received any influenza vaccine 1 year before screening in children aged over 3 years.\n\nExclusion Criteria:\n\nSubjects meeting any of the following exclusion criteria will be not eligible for enrollment.\n\n* Subjects with a history of severe allergy to egg or egg protein, such as those who have had symptoms such as angioedema, dyspnea, chest distress, or repeated vomiting due to eating eggs, and even those who have used epinephrine or other emergency medical treatment, especially those who have symptoms immediately or within a short period (minutes to hours).\n* Subjects with influenza illness (clinically, serologically, or microbiologically confirmed) within 6 months before screening and enrollment.\n* Have received an influenza vaccine within 1 year before enrollment or scheduled to receive another influenza vaccine during the study period.\n* Allergic to any component contained in the investigational vaccine, or previous history of severe allergic to any vaccine or drug, such as anaphylactic shock, laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, local allergic necrosis reaction, dyspnea, angioedema, systemic rash and\u002For urticaria, etc.\n* History of taking administration of a non-SARS-CoV-2 inactivated vaccine or subunit vaccine within 7 days before enrollment, or any live attenuated vaccine or SARS-CoV-2 vaccine within 14 days before enrollment, or subjects have scheduled to receive another vaccine within 1 month after receipt of the investigational vaccine\n* Subjects with convulsion, epilepsy, encephalopathy (such as moderate to severe hypoxic-ischemic encephalopathy, intracranial hemorrhage, cerebral palsy, intracranial tumor, cerebral infarction, stroke, intracranial infection, etc.), psychiatric history or family history\n* Have been diagnosed with a serious medical condition or congenital malformation that may interfere with the conduct or completion of the study (including but not limited to suffering from respiratory diseases such as asthma or during episodes of chronic bronchitis, Down syndrome, thalassemia, heart disease, severe cardiac arrhythmias, kidney disease, diabetes (diabetics with poor glycemic control or severe complications), autoimmune diseases, genetic allergies, Guillain-Barre syndrome, Crohn disease, malignancies, severe infectious\u002Fallergic skin diseases, etc.)\n* Adults aged 18 years or older with medically uncontrolled abnormal blood pressure (systolic blood pressure ≥140mmHg and\u002For diastolic blood pressure ≥90mmHg or systolic blood pressure ≤ 90mmHg and\u002For diastolic blood pressure ≤ 60 mmHg)\n* Subjects with acute illness or in the acute phase of a chronic illness within 3 days before vaccination\n* Subjects with fever (axillary temperature ≥37.3 ° C) within 3 days before vaccination or use of antipyretic, analgesic, or antiallergic medications\n* Subjects with a hereditary bleeding tendency or coagulopathy, or a history of bleeding disorders\n* Have received a blood transfusion or use of blood products within 3 months before enrollment, or planned to do so within 1 month after full immunization\n* History of surgical removal of the spleen or other vital organs for any reason\n* Use of any investigational or unregistered product (drug, vaccine, biological product, or device) other than a study vaccine within 3 months before enrollment or planned for use during the study\n* Have treatment with immunosuppressive agents within 6 months before enrollment, such as long-term systemic glucocorticoid therapy (e.g., prednisone or a similar drug for more than 2 consecutive weeks within 6 months), but topical use (e.g., ointments, eye drops, inhalers, or nasal sprays) was allowed. Topical use should not exceed the recommended dose on the label or have any signs of systemic exposure\n* Have been diagnosed with an infectious disease that may interfere with the conduct or completion of the study, such as active tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, etc\n* Being lactating, pregnant (including a positive urine pregnancy test), or planning to become pregnant within 6 months of vaccination\n* Subjects plan to move out of the local area before the end of the study or leave the local area for an extended period during the scheduled study visit\n* Subjects with abnormal vital signs with clinical significance\n* Investigators' Discretion: The final exclusion criterion is the discretion of investigators to determine whether a subject is suitable for participation in the study.","3 Years",{"count":106,"type":21},4400,[108],"PHASE3","This is a randomized, blinded, active-controlled phase III clinical trial to evaluate the immunogenicity and safety of the Quadrivalent Influenza Virus Split Vaccine (QIV) in subjects (aged 3 years and above). Primary immunogenicity endpoints are the geometric mean titers, geometric mean fold increases, seropositive rates, and seroconversion rates of anti-influenza virus HI antibodies for all types 30 days after immunization, and primary safety endpoints are the occurrence of safety events after vaccination including the incidence of adverse events\u002Fadverse reactions within 30 minutes\u002F7 days\u002F30 days after immunization, as well as the incidence of serious adverse events\u002Fadverse relations within 6 months which will be defined as the secondary safety endpoint. Besides, the secondary endpoints are to evaluate the same index above in different administration programs in children aged 3-8 years.",[111,112,113,114,115],"Influenza, Human","Influenza, Human Prevention","Influenza a","Influenza B","Influenza Viral Infections","2025-01-24",{"date":118,"type":37},"2025-01-30",{"date":120,"type":21},"2025-02-08",{"date":122,"type":21},"2025-10-15",{"name":43,"class":44},3,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":16,"sex":17,"minAge":132,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":124},"100551473","phase-4-phase-iv-study-of-concomitant-administration-of-the-sipv-and-hepa-100551473","NCT06460545","Phase IV Study of Concomitant Administration of the sIPV and HepA","Phase IV Study of Evaluating Immunogenicity and Safety of Concomitant Administration of Sabin-strain-based Inactivated Poliovirus Vaccine (Vero Cells) and Freeze-dried Live-attenuated Hepatitis A Vaccine or Inactivated Hepatitis A Vaccine","Inclusion Criteria:\n\n* Age Requirement: Children aged 4 months at the time of enrollment\n* Vaccination Requirement: volunteers have already taken administration 2 doses of sabin-strain-based inactivated poliovirus vaccine (produced by IMBCAMS), and have not yet been injected with the third dose containing poliovirus antigen.\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, and sign the informed consent form.\n* Adherence: Legal guardians or appointed representatives of volunteers must be able to comply with the requirements in the study as well as complete relevant visits on time.\n* Birth condition: Full-term birth (37\\~42 gestational weeks) and normal birth weight (no less than 2500g).\n* Temperature Requirement: Axillary body temperature prior to vaccination is less than 37.3°C.\n\nExclusion Criteria:\n\n* Health Requirement: Volunteers cannot meet health requirements through physical examinations.\n* History of Related Illness: Volunteers have a history of developing Hepatitis A, poliomyelitis, or immunodeficiency.\n* Birth Condition: Volunteers have a history of abnormal labor stage, asphyxia, nervous system damage, or clinically confirmed pathologic jaundice。\n* Allergic History: Volunteers have a history of allergies to any component of the investigational vaccine (e.g., aluminum hydroxide), any history of vaccine allergies, suspected allergies, or any other severe adverse reactions.\n* Vaccine History: Volunteers received any inactivated vaccines or subunit vaccines within 7 days (including the 7th day) prior to vaccination with the investigational vaccine, or any other live attenuated vaccines within 14 days (including the 14th day) prior to vaccination.\n* Acute Illness: Volunteers have experienced acute illnesses (e.g., fever) within 3 days prior to vaccination with the investigational vaccine.\n* Neurological and Mental Health: Volunteers have a history of seizures, convulsions, cerebral palsy, epilepsy, mental illness, or a family history of such conditions.\n* Health Conditions: Volunteers have known congenital abnormalities, developmental disorders, genetic defects, or severe malnutrition, among other conditions.\n* Coagulation Abnormalities: Volunteers have a history of coagulation disorders (e.g., coagulation factor deficiency, coagulation disorders).\n* Infectious Diseases: Volunteers have infectious diseases that may affect the study, such as human immunodeficiency virus (HIV) infection, hepatitis, and tuberculosis.\n* Special Condition: Volunteers who could not tolerate venipuncture, or had a history of needle and blood sickness.\n* Organ Removal History: Volunteers have a history of organ removal (e.g., thyroid, pancreas, liver, spleen).\n* History of Blood Products: Volunteers have a history of loss of blood, blood transfusion, the use of adjuvant therapies, or immunoglobulin within 3 months prior to vaccination.\n* Immune Therapy: Volunteers have received immune-enhancing or immune-suppressing therapy within the last 3 months (continuous oral or intravenous administration for more than 14 days) prior to vaccination.\n* Participation in Other Clinical Studies: Volunteers are currently or have plans to participate in other clinical studies before enrollment.\n* Investigator's Discretion: The final exclusion criterion is the investigator's discretion to determine whether a volunteer is suitable for participation in the study.","4 Months",{"count":134,"type":21},2000,[82],"This study is a randomized, open-labeled phase IV clinical trial to evaluate the immunogenicity and safety of concomitant administration of sIPV and HepA-L or HepA-I in children aged 18 months. The primary immunogenicity endpoints in all groups are the seroconversion rates of type I, II, and III anti-poliovirus neutralizing antibodies and the seroconversion rate of anti-hepatitis A virus antibodies 30 days after the final administration. The secondary immunogenicity endpoints are (1) the GMT\u002FGMC of type I, II, and III anti-poliovirus neutralizing antibodies as well as the anti-hepatitis A virus antibodies 30 days after the final administration; (2) the seropositive rates of the anti-hepatitis A virus antibodies 30 days after the final administration; (3) the GMFI of type I, II, and III anti-poliovirus neutralizing antibodies as well as the anti-hepatitis A virus antibodies 30 days after the final administration. The secondary safety endpoints are the incidence of adverse events (AEs) within 30 minutes after each injection, the incidence of solicited local and systematic AEs in the period of solicitation after each injection, the incidence of unsolicited AEs in 30 days after each injection, the incidence of AEs in 30 days after each injection, and the incidence of serious adverse events in 6 months after administrations.",[85,138],"Hepatitis A","2024-06-11",{"date":141,"type":37},"2024-06-14",{"date":143,"type":21},"2024-06-15",{"date":145,"type":21},"2027-12-15",{"name":43,"class":44},{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":16,"sex":17,"minAge":53,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":160,"overallStatus":163,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},"100527309","phase-4-lot-to-lot-consistency-study-of-three-commercial-batches-of-enterovirus-71-vaccine-100527309","NCT06146088","Lot-to-lot Consistency Study of Three Commercial Batches of Enterovirus 71 Vaccine","To Evaluate the Lot-to-lot Consistency of Immunogenicity, Safety, and Immune Persistence of Three Consecutive Commercial Manufacturing Batches of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell) in Children Aged 6-35 Months in a Randomized, Blinded Study","Inclusion Criteria:\n\n* Age Requirement: Children aged 6 to 35 months at the time of enrollment.\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 study's requirements and complete relevant visits on time.\n* Temperature Requirement: Axillary body temperature prior to vaccination is less than 37.3°C.\n\nExclusion Criteria:\n\n\\[First Dose Exclusion Criterions\\] Subjects meeting any of the following exclusion criteria will not be eligible for enrollment\n\n* Allergic History: Subjects have a previous history of allergies to any component of the vaccine (e.g., aluminum hydroxide, glycine), or previous or suspected allergy to any vaccine or other serious adverse reaction (e.g., anaphylactic shock, laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, local anaphylactic necrosis reaction, dyspnea, angioedema, systemic rash and\u002For urticaria, etc.).\n* Vaccination History: Subjects received any inactivated vaccine or subunit vaccine within 7 days prior to the first dose of the investigational vaccine or any live attenuated vaccine within 14 days prior to the first dose of the investigational vaccine.\n* Neurological and Mental Health: Subjects with a history or family history of convulsion, epilepsy, encephalopathy, and psychosis.\n* Health Conditions: Subjects with known severe congenital malformation or developmental disorder (e.g., Down syndrome, sickle cell anemia, congenital neurological disorders).\n* Acute Illness: Subjects have experienced acute illness (e.g., fever) or acute onset of chronic illness within 3 days before the first dose of investigational vaccine, or use of antipyretic, analgesic, or antiallergic drugs within 3 days before the first dose of the investigational vaccine.\n* Coagulation Abnormalities: Subjects with genetic bleeding tendency, coagulopathy, or a history of bleeding disorders.\n* Organ Removal History: Subjects have a history of surgical removal of the spleen or other vital immune organs for any reason.\n* Blood Conditions: Subjects with blood loss (≥400mL) or receipt of blood transfusion, immune globulin (other than hepatitis B immune globulin), or blood products within 3 months prior to the first dose of the investigational vaccine.\n* Drug Administration: Subjects use any investigational or unregistered product (drug, biological product, or device) within 3 months prior to the first dose of the investigational vaccine, or planned use during the study, except the investigational vaccine.\n* Immune Therapy: Subjects have a treatment with immunosuppressive agents within 6 months before the first dose of the investigational vaccine, such as long-term treatment with systemic glucocorticoids (e.g., prednisone or a similar agent for more than 2 consecutive weeks within 6 months), but topical use (e.g., ointments, eye drops, inhalers, or nasal sprays) would be allowed.\n* Previous history of receipt of other EV71 vaccines.\n* Previous history of hand-foot-mouth disease.\n* Immune-related Disease: Subjects have been diagnosed with an infectious disease that may interfere with the conduct or completion of the study (e.g., tuberculosis, viral hepatitis, human immunodeficiency virus infection, etc.).\n* Investigators' Discretion: The final exclusion criterion is the investigator's discretion to determine whether a subject is suitable for participation in the study.\n\n\\[Contraindication of the second dose of vaccine\\] Subjects meeting any of the following exclusion criteria will not be eligible for the second dose of the investigational vaccine\n\n* Meeting allergic conditions that are mentioned in the First Dose Exclusion Criteria after the first dose.\n* Severe Adverse Reactions: Subjects experienced serious adverse reactions after receiving the previous vaccine dose.\n* Other Exclusion Reasons as Determined by the Investigator: The investigator determines other reasons for exclusion.","35 Months",{"count":156,"type":21},1500,[82],"This study is a randomized, blinded study to evaluate the lot-to-lot consistency of immunogenicity, safety, and immune persistence of three consecutive manufacturing lots of EV71 vaccine, in 1500 children aged 6-35 months. The primary immunogenicity endpoint is the anti-EV71 neutralizing antibody geometric mean titer (GMT) 30 days after the final dose. The secondary immunogenicity endpoints are the geometric mean fold increases and seroconversion rates of anti-EV71 neutralizing antibodies 30 days after the final dose. The immune persistence endpoints are the seropositive rates as well as GMT of anti-EV71 neutralizing antibodies 12 and 24 months after the final dose. The safety endpoints are the number of adverse events\u002Freactions within 30 minutes after each dose, the number of solicited adverse events\u002Freactions within 7 days after each dose, the number of unsolicited adverse events\u002Freactions within 30 days after each dose, and the number of serious adverse events (SAE) from the first dose to 6 months post the final dose.",[62],[161,162],"Enterovirus 71","Inactivated enterovirus 71 vaccine","RECRUITING","2024-01-01",{"date":166,"type":37},"2024-01-03",{"date":168,"type":37},"2023-11-25",{"date":170,"type":21},"2026-07-15",{"name":43,"class":44},4,{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":16,"sex":17,"minAge":78,"maxAge":18,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":163,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":124},"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.",{"count":181,"type":21},460,[24],"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.",[30,29,31],{"date":166,"type":37},{"date":187,"type":37},"2023-12-23",{"date":189,"type":21},"2026-11-01",{"name":43,"class":44},""]