[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hfmd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hfmd":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100618073","phase-1-phase-i-clinical-trial-of-enterovirus-type71---coxsackievirus-type-a16-bivalent-vaccine-100618073",false,"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.",true,"ALL","6 Months","59 Years",{"count":21,"type":22},144,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","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 ).",[28,29,30],"Hand, Foot and Mouth Disease (HFMD)","HFMD","Hand, Foot and Mouth Disease","NOT_YET_RECRUITING","2025-12-26",{"date":34,"type":35},"2026-01-08","ACTUAL",{"date":37,"type":22},"2025-12-30",{"date":39,"type":22},"2027-08-15",{"name":41,"class":42},"Institute of Medical Biology, Chinese Academy of Medical Sciences","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100593616","clinical-trial-of-pegylated-interferon--2b-via-nebulization-for-treatment-of-hand-foot-and-mouth-disease--100593616","NCT07008755","Clinical Trial of Pegylated Interferon α-2b Via Nebulization for Treatment of Hand, Foot, and Mouth Disease .","Clinical Trial of Different Doses of Pegylated Interferon α-2b Injection Nebulization Therapy for Common Hand, Foot, and Mouth Disease (HFMD).","Inclusion Criteria:\n\n-1. Age: 1 year of age ≤ Age ≤ 6 years of age. 2.Gender: Both male and female. 3.Clinical symptoms\u002Fsigns: Manifesting as common type HFMD (Stage 1, rash stage), with fever or rash symptoms first occurring within 72 hours prior to the signing of the informed consent form.\n\n4.Informed consent: Guardians understand and sign the informed consent form (if the guardian is the parent, both parents must sign).\n\nExclusion Criteria:\n\n* (1) Severe or Critical HFMD Presentation at Enrollment\n\n  1. Manifesting as severe HFMD (Stage 2, neurological involvement phase)\n  2. Manifesting as critical HFMD (Stage 3 or 4, cardiopulmonary failure phase) with any of:\n\n     Brainstem encephalitis, encephalomyelitis, or meningitis,Neurogenic pulmonary edema or respiratory failure requiring mechanical ventilation,Shock or circulatory collapse.\n  3. Concurrent multi-organ failure requiring ICU monitoring\n\n     (2) Allergy History and Treatment History\n\n  \u003C!-- -->\n\n  1. Received interferon, ribavirin, acyclovir, ganciclovir, or vidarabine monophosphate within 30 days prior to screening or current use\n  2. Received immunoglobulin or glucocorticoid therapy within 30 days prior to screening or current use\n  3. Known hypersensitivity to interferon or its components, or other clinically significant allergies contraindicating participation\n  4. Use of other investigational drugs within 3 months or 5 half-lives (whichever is longer) prior to screening, or current participation in medical device trials\n\n     (3) Medical History\n\n  \u003C!-- -->\n\n  1. Congenital heart disease, severe malnutrition, immune dysfunction, asthma, or other severe systemic diseases\n  2. Active HBV, HCV, HIV, or Treponema pallidum infection\n  3. History of malignant tumors (current or prior)\n  4. History of epilepsy, neurological\u002Fpsychiatric disorders, or relevant family history\n\n     (4) Clinical Parameters: Resting respiratory rate \\>40 breaths\u002Fmin,Heart rate \\>160 bpm\n\n     (5) Other Considerations: Any condition deemed by investigators to render participation medically inadvisable","1 Year","6 Years",{"count":54,"type":22},90,[56],"NA","This is a multicenter clinical trial investigating the safety and efficacy of inhaled Peginterferon α-2b at different doses, in combination with supportive care, for the treatment of patients with hand, foot, and mouth disease (HFMD) of ordinary type. The trial aims to enroll 90 patients with HFMD. Eligible subjects will be randomly assigned to receive either supportive care + Peginterferon α-2b mcg or supportive care + Peginterferon α-2b 90 mcg, administered on days 1 and 3. The study period includes a 3-day screening phase and a 5-7 day inpatient visit period. The results of this trial will be used to evaluate safety and efficacy.",[29],[60,29],"Peginterferon α-2b injection","RECRUITING","2025-05-29",{"date":64,"type":35},"2025-06-06",{"date":66,"type":35},"2024-07-31",{"date":68,"type":22},"2027-12-31",{"name":70,"class":42},"Zhengzhou Children's Hospital, China",5]