[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diphtheria-tetanus-and-acellular-pertussis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diphtheria-tetanus-and-acellular-pertussis":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"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":20,"type":21},260,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Diphtheria, Tetanus and Acellular Pertussis","Epidemic Meningitis","Haemophilus Influenzae Type B Infection",[31,32,33,34],"Combined Vaccine","Safety","Immunogenicity","Ages 2 months to 6 years","RECRUITING","2025-12-25",{"date":38,"type":39},"2025-12-31","ACTUAL",{"date":41,"type":39},"2025-12-19",{"date":43,"type":21},"2029-02",{"name":45,"class":46},"CanSino Biologics Inc.","INDUSTRY",""]