[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"epidemic-meningitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:epidemic-meningitis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,61,79,97],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100631838","phase-3-phase--trial-of-group-acyw135-meningococcal-conjugate-vaccine-in-children-aged-2-6-years-100631838",false,"NCT07505888","Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 2-6 Years","A Randomized, Double-Blind, Active Comparator-Controlled Phase Ⅲ Trial to Evaluate the Immunogenicity and Safety of Group ACYW135 Meningococcal Conjugate Vaccine in Population Aged 2-6 Years","Inclusion Criteria:\n\n1. Healthy participants aged 2 to 6 years.\n2. The participant's legal guardian is capable of understanding and voluntarily signs the informed consent form.\n3. Willing and able to comply with all scheduled visits, sample collection, vaccination, and other trial procedures.\n4. Provision of legal identification documentation.\n\nExclusion Criteria:\n\n1. History (or suspected history) of meningococcal disease.\n2. History of infantile wheezing\u002Fasthma; history of allergy to the vaccine or any vaccine components (Group A\u002FC\u002FY\u002FW135 meningococcal capsular polysaccharide, mannitol, sucrose, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dodecahydrate, sodium chloride, water for injection), such as urticaria, dyspnea, angioedema; or other serious adverse reactions following prior vaccination.\n3. Prior vaccination with Group A or Group A\u002FC meningococcal polysaccharide vaccine with an interval ≤1 year since the most recent dose; prior vaccination with any meningococcal polysaccharide\u002Fpolysaccharide conjugate vaccine other than Group A or Group A\u002FC meningococcal polysaccharide vaccines (including but not limited to: ACYW135 meningococcal polysaccharide vaccine, Group A\u002FC meningococcal polysaccharide conjugate vaccine, ACYW135 meningococcal polysaccharide conjugate vaccine).\n4. Presence of autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection in the participant or the participant's mother).\n5. Coagulation disorders (e.g., coagulation factor deficiency, platelet abnormalities) or history of significant bleeding, hematoma, or ecchymosis following intramuscular injection or venipuncture.\n6. Presence of poorly controlled chronic diseases or history of serious illnesses, including but not limited to cardiovascular diseases, metabolic diseases, hematological diseases, hepatorenal diseases, gastrointestinal diseases, respiratory diseases, malignancies, or history of major organ transplantation.\n7. Severe congenital anomalies, genetic defects, or malnutrition.\n8. Presence of or history of severe neurological disorders \\[epilepsy, convulsions or seizures (excluding history of febrile seizures)\\] or psychiatric disorders, or family history of psychiatric disorders.\n9. Receipt of immunoglobulins or other blood products within 3 months prior to enrollment, or planned receipt of such treatments during the trial period.\n10. Receipt of immunosuppressants or other immunomodulatory therapy for ≥14 days (e.g., prednisone ≥20 mg\u002Fday or ≥2 mg\u002Fkg\u002Fday, or equivalent), cytotoxic therapy within 6 months prior to enrollment, or planned receipt of such therapies during the study period.\n11. Receipt of any other investigational drug or vaccine within 3 months prior to enrollment, or planned receipt during the study period.\n12. Receipt of a live virus vaccine within 2 months prior to enrollment.\n13. Receipt of influenza vaccine within 15 days prior to enrollment, or planned receipt of influenza vaccine within 15 days post-enrollment, or planned receipt of influenza vaccine between Days 16-28 post-enrollment at an injection site different from the study vaccine cannot be ensured.\n14. Receipt of any other licensed vaccine (excluding live virus vaccines and influenza vaccine) within 1 month prior to enrollment, or planned receipt of any other licensed vaccine (excluding influenza vaccine) within 1 month post-enrollment.\n15. Acute illness or acute exacerbation of chronic disease within 3 days prior to enrollment, or known or suspected active infection.\n16. Fever (axillary temperature \\>37.0°C) on the day of scheduled study vaccination, or abnormal findings on physical examination that preclude vaccination.\n17. Skin lesions, inflammation, ulcers, rash, or scarring at the intended injection site that may interfere with vaccination or local reaction assessment.\n18. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this clinical trial.",true,"ALL","2 Years","6 Years",{"count":21,"type":22},660,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The goal of this clinical trial is to evaluate the immunogenicity and safety of an investigational group ACYW135 meningococcal conjugate vaccine in healthy children aged 2 to 6 years.\n\nThe main questions it aims to answer are:\n\nIs the immune response induced by the investigational vaccine non-inferior to that of the licensed control vaccine, as measured by serum antibody levels? What safety profile does the investigational vaccine have in this pediatric population? Researchers will compare the investigational vaccine group with the control group (licensed ACYW135 polysaccharide vaccine) to determine if the new vaccine provides comparable immune protection with an acceptable safety profile.\n\nParticipants will:\n\nReceive a single dose of either the investigational vaccine or the control vaccine by intramuscular injection; Provide two blood samples (before vaccination and 30 days after) for antibody testing; Have their vaccination site and overall health monitored for AE\u002FAR immediately after injection, for 7 days and for 30 days through diary card and follow-up contacts; Be followed for serious adverse events for 6 months after vaccination. A total of 660 participants will be enrolled and randomly assigned in a 1:1 ratio to either the investigational group or the control group.",[28,29],"Epidemic Meningitis","Meningococcal Vaccines","NOT_YET_RECRUITING","2026-03-29",{"date":33,"type":34},"2026-04-01","ACTUAL",{"date":36,"type":22},"2026-03-22",{"date":38,"type":22},"2026-11",{"name":40,"class":41},"Sinovac Biotech Co., Ltd","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":58,"leadSponsor":60,"locationsCount":4},"100631832","phase-3-phase--trial-of-group-acyw135-meningococcal-conjugate-vaccine-in-children-aged-3-5-months-100631832","NCT07505810","Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months","A Randomized, Double-Blind, Active Comparator-Controlled Phase Ⅲ Trial to Evaluate the Immunogenicity and Safety of the Group ACYW135 Meningococcal Conjugate Vaccine in Population Aged 3 to 5 Months","Inclusion Criteria:\n\n1. Healthy participants aged 3 to 5 months.\n2. The participant's legal guardian is capable of understanding and voluntarily signs the informed consent form.\n3. Willing and able to comply with all scheduled visits, sample collection, vaccination, and other trial procedures.\n4. Provision of legal identification documentation.\n\nExclusion Criteria:\n\n1. History (or suspected history) of meningococcal disease.\n2. History of infantile wheezing; history of allergy to the vaccine or any vaccine components (Group A\u002FC\u002FY\u002FW135 meningococcal capsular polysaccharide, mannitol, sucrose, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dodecahydrate, sodium chloride, water for injection), such as urticaria, dyspnea, angioedema; or other serious adverse reactions following prior vaccination.\n3. Prior vaccination with any meningococcal vaccine (including but not limited to: Group A meningococcal polysaccharide vaccine, Group A\u002FC meningococcal polysaccharide\u002Fconjugate vaccine, ACYW135 meningococcal polysaccharide\u002Fconjugate vaccine, etc.).\n4. Presence of autoimmune diseases, immunodeficiency diseases (including but not limited to asplenia, functional asplenia, HIV infection in the participant or the participant's mother), current perianal abscess, or severe eczema.\n5. Coagulation disorders (e.g., coagulation factor deficiency, platelet abnormalities) or history of significant bleeding, hematoma, or ecchymosis following intramuscular injection or venipuncture.\n6. Presence of poorly controlled persistent disease conditions or history of serious illnesses, including but not limited to cardiovascular diseases, hematological diseases, hepatorenal diseases, gastrointestinal diseases, respiratory diseases, malignancies, or history of major organ transplantation.\n7. Severe congenital anomalies, genetic defects, or malnutrition.\n8. Newborn gestational age \\\u003C37 weeks or ≥42 weeks.\n9. Birth weight \\\u003C2500g or \\>4000g, or history of difficult birth, resuscitation at birth, or neurological damage.\n10. Presence of or history of severe neurological disorders \\[epilepsy, convulsions or seizures\\], or family history of psychiatric disorders.\n11. Receipt of immunoglobulins or other blood products within the past 3 months, or planned receipt of such treatments during the study period.\n12. Prior receipt of immunosuppressants or other immunomodulatory therapy for ≥14 days (e.g., prednisone ≥20 mg\u002Fday or ≥2 mg\u002Fkg\u002Fday, or equivalent), cytotoxic therapy, or planned receipt of such therapies during the study period.\n13. Receipt of any other investigational drug or vaccine within the past 3 months, or planned receipt during the study period.\n14. Receipt of a live attenuated vaccine within the past 14 days, or receipt of a subunit or inactivated vaccine within the past 7 days.\n15. Receipt of any other licensed vaccine within the past 28 days where administration at a different injection site from the study vaccine cannot be ensured.\n16. Acute illness or acute exacerbation of persistent disease conditions within the past 3 days, or known or suspected active infection.\n17. Fever (axillary temperature \\>37.0°C) on the day of scheduled study vaccination, or abnormal findings on physical examination that preclude vaccination.\n18. Skin lesions, inflammation, ulcers, rash, or scarring at the intended injection site that may interfere with vaccination or local reaction assessment.\n19. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this clinical trial.","3 Months","5 Months",{"count":52,"type":22},880,[25],"The goal of this clinical trial is to evaluate the immunogenicity, safety, and immune persistence of the primary series of an investigational group ACYW135 meningococcal conjugate vaccine, as well as the immunogenicity and safety of a booster dose administered at 12 months of age, in healthy children aged 3 to 5 months.\n\nThe main questions it aims to answer are:\n\nIs the immune response induced by the primary series of the investigational vaccine non-inferior to that of the licensed control vaccine? What is the safety profile of the investigational vaccine during the primary series and booster dose? Does the investigational vaccine provide immune persistence up to 12 months of age? What is the immunogenicity of a booster dose administered at 12 months of age? Researchers will compare the investigational vaccine group with the active comparator group (CanSinoBIO MCV-ACYW) during both the primary immunization phase and the booster phase.\n\nParticipants will:\n\nBe randomly assigned in a 1:1 ratio to receive either three doses of the investigational vaccine or three doses of the control vaccine according to a 0,1,2-month schedule during the primary immunization phase; Receive a booster dose at 12 months of age (either investigational vaccine or control vaccine according to group assignment); Provide blood samples at four time points: before primary vaccination, 30 days after primary vaccination, before booster vaccination (12 months of age), and 30 days after booster vaccination; Be observed for 30 minutes after each dose for immediate adverse reactions; Have solicited local and systemic adverse events recorded for 7 days after each dose using diary cards; Have unsolicited adverse events recorded for 30 days after each dose using diary cards; Be monitored for serious adverse events for at least 6 months after the last dose administered; A total of 880 participants will be enrolled.",[28,29],{"date":33,"type":34},{"date":36,"type":22},{"date":59,"type":22},"2028-01",{"name":40,"class":41},{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":16,"sex":17,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":4,"studyType":23,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":77,"leadSponsor":78,"locationsCount":4},"100631833","phase-3-phase--trial-of-group-acyw135-meningococcal-conjugate-vaccine-in-children-aged-6-11-months-100631833","NCT07505823","Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 6-11 Months","A Randomized, Double-Blind, Active Comparator-Controlled Phase Ⅲ Trial to Evaluate the Immunogenicity and Safety of the Group ACYW135 Meningococcal Conjugate Vaccine in Population Aged 6 to 11 Months","Inclusion Criteria:\n\n1. Healthy participants aged 6 to 11 months.\n2. The participant's legal guardian is capable of understanding and voluntarily signs the informed consent form.\n3. Willing and able to comply with all scheduled visits, sample collection, vaccination, and other trial procedures.\n4. Provision of legal identification documentation.\n\nExclusion Criteria:\n\n1. History (or suspected history) of meningococcal disease.\n2. History of infantile wheezing; history of allergy to the vaccine or any vaccine components (Group A\u002FC\u002FY\u002FW135 meningococcal capsular polysaccharide, mannitol, sucrose, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dodecahydrate, sodium chloride, water for injection), such as urticaria, dyspnea, angioedema; or other serious adverse reactions following prior vaccination.\n3. Prior vaccination with any meningococcal vaccine (including but not limited to: Group A\u002FC meningococcal polysaccharide\u002Fconjugate vaccine, ACYW135 meningococcal polysaccharide\u002Fconjugate vaccine, Group A meningococcal polysaccharide vaccine, etc.).\n4. Presence of autoimmune diseases, immunodeficiency diseases (including but not limited to asplenia, functional asplenia, HIV infection in the participant or the participant's mother), or current perianal abscess.\n5. Coagulation disorders (e.g., coagulation factor deficiency, platelet abnormalities) or history of significant bleeding, hematoma, or ecchymosis following intramuscular injection or venipuncture.\n6. Presence of poorly controlled chronic diseases or history of serious illnesses, including but not limited to cardiovascular diseases, hematological diseases, hepatorenal diseases, gastrointestinal diseases, respiratory diseases, malignancies, or history of major organ transplantation.\n7. Severe congenital anomalies, genetic defects, or malnutrition.\n8. Presence of or history of severe neurological disorders \\[epilepsy, convulsions or seizures\\], or family history of psychiatric disorders.\n9. Receipt of immunoglobulins or other blood products within the past 3 months, or planned receipt of such treatments during the study period.\n10. Receipt of immunosuppressants or other immunomodulatory therapy for ≥14 days (e.g., prednisone ≥20 mg\u002Fday or ≥2 mg\u002Fkg\u002Fday, or equivalent), cytotoxic therapy within the past 6 months, or planned receipt of such therapies during the study period.\n11. Receipt of any other investigational drug or vaccine within the past 3 months, or planned receipt during the study period.\n12. Receipt of a live attenuated vaccine within the past 14 days, or receipt of a subunit or inactivated vaccine within the past 7 days.\n13. Receipt of any other licensed vaccine within the past 28 days where administration at a different injection site from the study vaccine cannot be ensured.\n14. Acute illness or acute exacerbation of chronic disease within the past 3 days, or known or suspected active infection.\n15. Fever (axillary temperature \\>37.0°C) on the day of scheduled study vaccination, or abnormal findings on physical examination that preclude vaccination.\n16. Skin lesions, inflammation, ulcers, rash, or scarring at the intended injection site that may interfere with vaccination or local reaction assessment.\n17. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this clinical trial.","6 Months","11 Months",{"count":71,"type":22},1040,[25],"The goal of this clinical trial is to evaluate the immunogenicity, safety, and persistence of the immune response of a group ACYW135 meningococcal conjugate vaccine in healthy children aged 6 to 11 months.\n\nThe main questions it aims to answer are:\n\nIs the immune response induced by the investigational vaccine non-inferior to that of the licensed control vaccine following the primary series? What is the safety profile of the investigational vaccine during the primary series and booster dose? Does the investigational vaccine provide durable immune persistence up to 18 months of age? What is the immunogenicity of a booster dose administered at 18 months of age? Researchers will compare the investigational vaccine group with the active comparator group (licensed group ACYW135 meningococcal conjugate vaccine (CRM197 carrier), CanSinoBIO) during the primary immunization phase. Only the investigational group will receive a booster dose at 18 months of age to evaluate booster immunogenicity and safety.\n\nParticipants will:\n\nBe randomly assigned in a 1:1 ratio to receive either two doses of the investigational vaccine or two doses of the control vaccine according to a 0,1-month schedule during the primary immunization phase; In the investigational group only, receive a booster dose at 18 months of age; Provide blood samples at three time points: before primary vaccination, 30 days after primary vaccination, and at 18 months of age to assess primary immunogenicity and immune persistence; In the investigational group only, provide an additional blood sample 30 days after the booster dose to assess booster immunogenicity; Be observed for 30 minutes after each dose for immediate adverse reactions; Have solicited local and systemic adverse events recorded for 7 days after each dose using diary cards; Have unsolicited adverse events recorded for 30 days after each dose using diary cards; Be monitored for serious adverse events for at least 6 months after the last dose administered; A total of 1040 participants will be enrolled.",[28,29],{"date":33,"type":34},{"date":36,"type":22},{"date":59,"type":22},{"name":40,"class":41},{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":16,"sex":17,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100631834","phase-3-phase--trial-of-group-acyw135-meningococcal-conjugate-vaccine-in-children-aged-12-23-months-100631834","NCT07505836","Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 12-23 Months","A Randomized, Double-Blind, Active Comparator-Controlled Phase Ⅲ Trial to Evaluate the Immunogenicity and Safety of the Group ACYW135 Meningococcal Conjugate Vaccine in Population Aged 12 to 23 Months","Inclusion Criteria:\n\n1. Healthy participants aged 12 to 23 months.\n2. The participant's legal guardian is capable of understanding and voluntarily signs the informed consent form.\n3. Willing and able to comply with all scheduled visits, sample collection, vaccination, and other trial procedures.\n4. Provision of legal identification documentation.\n\nExclusion Criteria:\n\n1. History (or suspected history) of meningococcal disease.\n2. History of infantile wheezing; history of allergy to the vaccine or any vaccine components (Group A\u002FC\u002FY\u002FW135 meningococcal capsular polysaccharide, mannitol, sucrose, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dodecahydrate, sodium chloride, water for injection), such as urticaria, dyspnea, angioedema; or other serious adverse reactions following prior vaccination.\n3. Prior vaccination with Group A meningococcal polysaccharide vaccine with an interval ≤6 months since the most recent dose; prior vaccination with any other meningococcal vaccine other than Group A meningococcal polysaccharide vaccine (including but not limited to: Group A\u002FC meningococcal polysaccharide\u002Fconjugate vaccine, ACYW135 meningococcal polysaccharide\u002Fconjugate vaccine).\n4. Presence of autoimmune diseases or immunodeficiency diseases (including but not limited to asplenia, functional asplenia, HIV infection in the participant or the participant's mother).\n5. Coagulation disorders (e.g., coagulation factor deficiency, platelet abnormalities) or history of significant bleeding, hematoma, or ecchymosis following intramuscular injection or venipuncture.\n6. Presence of poorly controlled chronic diseases or history of serious illnesses, including but not limited to cardiovascular diseases, metabolic diseases, hematological diseases, hepatorenal diseases, gastrointestinal diseases, respiratory diseases, malignancies, or history of major organ transplantation.\n7. Severe congenital anomalies, genetic defects, or malnutrition.\n8. Presence of or history of severe neurological disorders \\[epilepsy, convulsions or seizures\\], or family history of psychiatric disorders.\n9. Receipt of immunoglobulins or other blood products within the past 3 months, or planned receipt of such treatments during the study period.\n10. Receipt of immunosuppressants or other immunomodulatory therapy for ≥14 days (e.g., prednisone ≥20 mg\u002Fday or ≥2 mg\u002Fkg\u002Fday, or equivalent), cytotoxic therapy within the past 6 months, or planned receipt of such therapies during the study period.\n11. Receipt of any other investigational drug or vaccine within the past 3 months, or planned receipt during the study period.\n12. Receipt of a live attenuated vaccine within the past 14 days, or receipt of a subunit or inactivated vaccine within the past 7 days.\n13. Receipt of any other licensed vaccine within the past 28 days where administration at a different injection site from the study vaccine cannot be ensured.\n14. Acute illness or acute exacerbation of chronic disease within the past 3 days, or known or suspected active infection.\n15. Fever (axillary temperature \\>37.0°C) on the day of scheduled study vaccination, or abnormal findings on physical examination that preclude vaccination.\n16. Skin lesions, inflammation, ulcers, rash, or scarring at the intended injection site that may interfere with vaccination or local reaction assessment.\n17. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this clinical trial.","12 Months","23 Months",{"count":71,"type":22},[25],"The goal of this clinical trial is to evaluate the immunogenicity and safety of an investigational group ACYW135 Meningococcal conjugate vaccine in healthy children aged 12 to 23 months.\n\nThe main questions it aims to answer are:\n\nIs the immune response induced by the investigational vaccine non-inferior to that of the licensed control vaccine? What safety profile does the investigational vaccine have in this pediatric population? Researchers will compare the investigational vaccine group with the active comparator group (licensed ACYW135 meningococcal conjugate vaccine (CRM197 carrier), CanSinoBIO; hereinafter referred to as CanSinoBIO MCV-ACYW) to determine if the new vaccine provides comparable immune protection with an acceptable safety profile.\n\nParticipants will:\n\nReceive two doses of either the investigational vaccine or the control vaccine according to a 0,1-month schedule; Be observed for 30 minutes after each dose for immediate adverse reactions; Have solicited local and systemic adverse events recorded for 7 days after each dose using diary cards; Have unsolicited adverse events recorded for 30 days after each dose using diary cards; Be monitored for serious adverse events for at least 6 months after completion of the primary immunization series; A total of 1040 participants will be enrolled and randomly assigned in a 1:1 ratio to either the investigational group or the control group.",[28,29],{"date":33,"type":34},{"date":36,"type":22},{"date":95,"type":22},"2027-01",{"name":40,"class":41},{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":16,"sex":17,"minAge":104,"maxAge":19,"enrollmentInfo":105,"targetDuration":4,"studyType":23,"phases":107,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"100608607","phase-1-clinical-trial-of-the-adsorbed-acellular-pertussis-tricomponent-dtap-haemophilus-influenzae-type-b-conjugate-acyw135-group-meningococcal-conjugate-combined-vaccine-100608607","NCT07203755","Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine","A Randomized, Partially Blinded, Dose-Exploratory, Active\u002FPlacebo-Controlled Phase I Clinical Trial Evaluating the Safety and Immunogenicity of the Adsorbed Acellular Pertussis (Tricomponent) DPT-Hib (Conjugate)-ACYW135-Group B Meningococcal (Conjugate) Combined Vaccine in Individuals Aged 2 Months to 6 Years","Inclusion Criteria:\n\nGeneral Inclusion Criteria:\n\n* Participants aged 2 months (60-89 days), 3 months (90-119 days), 18-24 months, and 6 years of age, with legal guardians or authorized representatives willing to provide identification documentation;\n* Legal guardians or authorized representatives provide informed consent, voluntarily sign the informed consent form, and are able to comply with the requirements of the clinical trial protocol;\n\nPart I: Specific Inclusion Criteria:\n\n* Individuals aged 18-24 months who have completed a 3-dose DTaP-containing vaccine series and a meningococcal-containing vaccine primary series, but have not received a DTaP-containing booster dose;\n* Individuals aged 6 years who have completed 4 doses of DTaP-containing vaccine but have not received the 5th DTaP-containing vaccine dose; and have only completed the first meningococcal-containing vaccine booster dose, without receiving the second meningococcal-containing vaccine booster dose at age 6.\n\nExclusion Criteria:\n\nGeneral Exclusion Criteria for First Dose：\n\n* Infants born prematurely (delivery before 37 weeks gestation) or with low birth weight (\\\u003C2500g) at 2 months (60-89 days) or 3 months (90-119 days) of age;\n* Infants aged 2 months (60-89 days) or 3 months (90-119 days) with history of abnormal labor, asphyxia requiring resuscitation, or neurological impairment;\n* Severe congenital malformations or developmental disorders, genetic defects, or severe malnutrition;\n* History of severe adverse reactions or anaphylaxis to vaccines or vaccine components, such as urticaria, dyspnea, angioedema;\n* History of epilepsy, convulsions, seizures, cerebral palsy, psychiatric disorders, or family history thereof; or history of progressive neurological diseases (e.g., Guillain-Barré syndrome, brachial plexus neuritis);\n* Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases;\n* Acute illness (e.g., fever ≥38.5°C, diarrhea) or acute exacerbation of chronic disease within 3 days prior to receiving the investigational product;\n* Known or suspected severe chronic diseases (including: severe respiratory disease, severe cardiovascular disease, liver\u002Fkidney disease, severe dermatology conditions, malignancies, etc.);\n* Current anal abscess or severe eczema;\n* Clinically diagnosed coagulation disorders (e.g., factor deficiency, bleeding disorders, platelet abnormalities) or significant bruising\u002Fcoagulation impairment;\n* Asplenia, functional asplenia, or splenectomy due to any cause;\n* Continuous treatment with immunosuppressants, immunomodulators, or cytotoxic agents (exceeding 10 days) within the past 6 months; inhaled or topical steroids are permitted;\n* Receipt of blood products or immunoglobulins (excluding hepatitis B immunoglobulin) within the past 3 months;\n* Received an injectable live attenuated vaccine within 14 days, or any other vaccine within 7 days;\n* Taken antipyretic analgesics or antiallergic medications within 3 days;\n* Fever present prior to vaccination, with axillary temperature ≥37.3°C (99.3°F);\n* Plans to participate in or is currently participating in any other drug\u002Fvaccine clinical trial;\n* Any other factors deemed by the investigator to make the subject unsuitable for participation in the clinical trial.\n\nPart I: Exclusion Criteria for the First Dose：\n\n* Infants aged 2 months (60-89 days) who have received vaccines containing meningococcal, DTP, or Haemophilus influenzae type b components;\n* Infants aged 3 months (90-119 days) who have received a vaccine containing meningococcal components;\n* Individuals aged 18-24 months who have received vaccines containing meningococcal or Haemophilus influenzae type b components within the past six months;\n* Individuals aged 18-24 months with abnormal pre-vaccination blood count or urinalysis results deemed clinically significant by the investigator;\n* Children aged 6 years who, prior to vaccination, exhibit abnormal results in relevant indicators of complete blood count, blood biochemistry, coagulation function, or urinalysis, and are deemed clinically significant by the investigator;\n* Individuals with a history of any of the following diseases: meningococcal meningitis, Haemophilus influenzae type b disease, pertussis, diphtheria, or tetanus.\n\nPart II: Specific Exclusion Criteria for the First Dose\n\n* History of vaccination with any meningococcal-containing vaccine;\n* History of meningococcal disease. General Exclusion Criteria for Subsequent Doses：\n* Occurrence of a serious adverse event related to vaccination following the previous dose;\n* Vaccine-related Grade 3 or higher allergic reaction following the previous dose;\n* Any other factors deemed by the investigator to make the subject unsuitable for continued participation in the clinical trial.","2 Months",{"count":106,"type":22},260,[108],"PHASE1","This clinical trial is conducted in two parts. Part One employs a randomized, partially blinded, dose-escalation, partially active-controlled design. Part Two utilizes a randomized, blinded, placebo-controlled design. Part One is divided into four stages based on age and vaccine dose levels. Part Two consists of the 2-month-old vaccine\u002Fplacebo groups.",[111,28,112],"Diphtheria, Tetanus and Acellular Pertussis","Haemophilus Influenzae Type B Infection",[114,115,116,117],"Combined Vaccine","Safety","Immunogenicity","Ages 2 months to 6 years","RECRUITING","2025-12-25",{"date":121,"type":34},"2025-12-31",{"date":123,"type":34},"2025-12-19",{"date":125,"type":22},"2029-02",{"name":127,"class":41},"CanSino Biologics Inc.",1]