[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608607":3},{"organization":4,"armGroups":7,"interventions":59,"overallOfficials":100,"centralContacts":105,"locations":111,"responsibleParty":128,"collaborators":65,"id":130,"slug":131,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":65,"eligibilityCriteria":136,"healthyVolunteers":137,"sex":138,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":65,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":152,"overallStatus":114,"whyStopped":65,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"CanSino Biologics Inc.","INDUSTRY",[8,14,18,21,25,28,34,39,44,49,53],{"label":9,"type":10,"description":11,"interventionNames":12},"Part I, 1A, low dose, 6 year-old","EXPERIMENTAL","One dose of DTcP-Hib-MCV4 on Day 0",[13],"Biological: Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis-Haemophilus influenzae type b (Conjugate)-Meningococcal Group ACYW135 (Conjugate) Combined Vaccine (DTcP-Hib-MCV4)",{"label":15,"type":10,"description":11,"interventionNames":16},"Part I, 2A, low dose, 18~24 month-old",[17],"Biological: DTcP-Hib-MCV4",{"label":19,"type":10,"description":11,"interventionNames":20},"Part I, 2B, high dose, 18~24 month-old",[17],{"label":22,"type":10,"description":23,"interventionNames":24},"Part I, 3A, low dose, 2 month-old","3 doses of DTcP-Hib-MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.",[17],{"label":26,"type":10,"description":23,"interventionNames":27},"Part I, 3B, high dose, 2 month-old",[17],{"label":29,"type":30,"description":31,"interventionNames":32},"Part I, 3C, 2 month-old","ACTIVE_COMPARATOR","3 doses of DTcP at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.",[33],"Biological: Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis (DTcP)",{"label":35,"type":30,"description":36,"interventionNames":37},"Part I, 3D, 2 month-old","3 doses of Hib at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.",[38],"Biological: Haemophilus influenzae type b (Conjugate) (Hib)",{"label":40,"type":30,"description":41,"interventionNames":42},"Part I, 3E, 2 month-old","3 doses of MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.",[43],"Biological: Meningococcal Group ACYW135 (Conjugate) (MCV4)",{"label":45,"type":30,"description":46,"interventionNames":47},"Part I, 4A, 3 month-old","3 doses of MCV4 at 0, 1, and 2 months, followed by a booster dose at 12 months of age.",[48],"Biological: MCV4",{"label":50,"type":10,"description":51,"interventionNames":52},"Part II, Vaccine Group, 2 month-old","3 doses of MCV4 at 0, 2, and 4 months.",[48],{"label":54,"type":55,"description":56,"interventionNames":57},"Part II, Placebo Group, 2 month-old","PLACEBO_COMPARATOR","3 doses of NS at 0, 2, and 4 months.",[58],"Other: Sodium Chloride Injection (0.9%) (Saline Solution) (NS)",[60,66,69,71,74,76,80,84,88,92,95],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"BIOLOGICAL","Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis-Haemophilus influenzae type b (Conjugate)-Meningococcal Group ACYW135 (Conjugate) Combined Vaccine (DTcP-Hib-MCV4)","1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0",[9],null,{"type":61,"name":67,"description":63,"armGroupLabels":68,"otherNames":65},"DTcP-Hib-MCV4",[15],{"type":61,"name":67,"description":63,"armGroupLabels":70,"otherNames":65},[19],{"type":61,"name":67,"description":72,"armGroupLabels":73,"otherNames":65},"3 doses of DTcP-Hib-MCV4 (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.",[22],{"type":61,"name":67,"description":72,"armGroupLabels":75,"otherNames":65},[26],{"type":61,"name":77,"description":78,"armGroupLabels":79,"otherNames":65},"Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis (DTcP)","3 doses of DTcP (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.",[29],{"type":61,"name":81,"description":82,"armGroupLabels":83,"otherNames":65},"Haemophilus influenzae type b (Conjugate) (Hib)","3 doses of Hib (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.",[35],{"type":61,"name":85,"description":86,"armGroupLabels":87,"otherNames":65},"Meningococcal Group ACYW135 (Conjugate) (MCV4)","3 doses of MCV4 (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.",[40],{"type":61,"name":89,"description":90,"armGroupLabels":91,"otherNames":65},"MCV4","3 doses of MCV4 (0.5ml) at 0, 1, and 2 months, followed by a booster dose at 12 months of age.",[45],{"type":61,"name":89,"description":93,"armGroupLabels":94,"otherNames":65},"3 doses of MCV4 (0.5ml) at 0, 2, and 4 months.",[50],{"type":96,"name":97,"description":98,"armGroupLabels":99,"otherNames":65},"OTHER","Sodium Chloride Injection (0.9%) (Saline Solution) (NS)","3 doses of NS (0.5ml) at 0, 2, and 4 months.",[54],[101],{"name":102,"affiliation":103,"role":104},"Yanxia Wang","Henan Center for Disease Control and Prevention","PRINCIPAL_INVESTIGATOR",[106],{"name":107,"role":108,"phone":109,"phoneExt":65,"email":110},"Ying Wang","CONTACT","022-58213600-6051","ying.wang@cansinotech.com",[112],{"facility":113,"status":114,"city":115,"state":116,"zip":65,"country":117,"countryCode":118,"cosmosGeoPoint":119,"geoPoint":124,"contacts":125},"Liangyuan District Center for Disease Control and Prevention, Shangqiu City","RECRUITING","Shangqiu","Henan","China","CN",{"type":120,"coordinates":121},"Point",[122,123],115.65613,34.4143,{"lat":123,"lon":122},[126],{"name":127,"role":108,"phone":65,"phoneExt":65,"email":65},"Qiang Liu",{"type":129,"investigatorFullName":65,"investigatorTitle":65,"investigatorAffiliation":65,"oldNameTitle":65,"oldOrganization":65},"SPONSOR","100608607","phase-1-clinical-trial-of-the-adsorbed-acellular-pertussis-tricomponent-dtap-haemophilus-influenzae-type-b-conjugate-acyw135-group-meningococcal-conjugate-combined-vaccine-100608607",false,"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.",true,"ALL","2 Months","6 Years",{"count":142,"type":143},260,"ESTIMATED","INTERVENTIONAL",[146],"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.",[149,150,151],"Diphtheria, Tetanus and Acellular Pertussis","Epidemic Meningitis","Haemophilus Influenzae Type B Infection",[153,154,155,156],"Combined Vaccine","Safety","Immunogenicity","Ages 2 months to 6 years","2025-12-25",{"date":159,"type":160},"2025-12-31","ACTUAL",{"date":162,"type":160},"2025-12-19",{"date":164,"type":143},"2029-02",{"name":5,"class":6},1]