[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"haemophilus-influenzae-type-b-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:haemophilus-influenzae-type-b-infection":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,79],{"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":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"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":21,"type":22},260,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30],"Diphtheria, Tetanus and Acellular Pertussis","Epidemic Meningitis","Haemophilus Influenzae Type B Infection",[32,33,34,35],"Combined Vaccine","Safety","Immunogenicity","Ages 2 months to 6 years","RECRUITING","2025-12-25",{"date":39,"type":40},"2025-12-31","ACTUAL",{"date":42,"type":40},"2025-12-19",{"date":44,"type":22},"2029-02",{"name":46,"class":47},"CanSino Biologics Inc.","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":16,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":4},"100563594","phase-2-study-to-evaluate-the-immunogenicity-of-lr20062-compared-to-control-when-administered-intramuscularly-in-healthy-infants-at-2-4-6-months-of-age-100563594","NCT06618196","Study to Evaluate the Immunogenicity of LR20062 Compared to Control When Administered Intramuscularly in Healthy Infants At 2, 4, 6 Months of Age","A Phase II, Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter Study to Evaluate the Immunogenicity and Safety of DTaP-HepB-IPV-Hib Hexavalent Vaccine LR20062 Versus Hexaxim Administered Intramuscularly in Healthy Infants As Primary Series At 2, 4, 6 Months of Age","Inclusion Criteria:\n\n1. Is male or female aged two months (50 to 70 days inclusive) on the day of the first dose of study vaccine.\n2. Is born at full term of pregnancy (≥37 weeks of gestation) with a birth weight of ≥2.5 kg.\n\nExclusion Criteria:\n\nMedical conditions:\n\n1. Has a history of diphtheria, tetanus, pertussis, poliovirus, Hep B, or Hib infection.\n2. Has a known SARS-CoV-2 infection at Screening.\n3. Was born to a mother with a known history of Hep B infection based on HBsAg seropositivity.\n4. Was born to a mother with a known history of HIV infection based on HIV antibody seropositivity.\n5. Had a recent febrile illness, defined as axillary temperature ≥38.0℃ \\[≥100.4℉\\] occurring at or within 72 hours prior to receipt of study vaccine.\n\n   Prior\u002Fconcomitant therapy:\n6. Has previously received vaccination against diphtheria, tetanus, pertussis, poliovirus, and\u002For Hib infections since birth.\n7. Has received or is expected to receive immunosuppressive agents or other immune-modifying drugs during the conduct of the study.\n8. Meets one or more of the following systemic corticosteroid exclusion criteria:\n\n   1. Has received systemic corticosteroids (equivalent of ≥0.5 mg\u002Fkg total daily dose of prednisone) for ≥14 consecutive days and has not completed treatment at least 30 days prior to Screening.\n   2. Is expected to require any systemic corticosteroids during conduct of the study.\n\n   Note: Topical, ophthalmic, and inhaled steroids are permitted at the discretion of the Investigator.\n9. Has received any non-study vaccine within 30 days before the first dose of study vaccine or is scheduled to receive any other vaccine within one month after the third dose of study vaccine.\n\nException: Vaccines against BCG and Hep B at birth, rotavirus, MMR, and PCV if received according to the routine immunization schedule, and inactivated influenza vaccine, are allowed.","50 Days","70 Days",{"count":59,"type":22},336,[61],"PHASE2","This is a phase II, randomized, double-blind, active-controlled, parallel-group, multicenter study to evaluate the immunogenicity and safety of DTaP-HepB-IPV-Hib hexavalent vaccine LR20062 in healthy infants as primary series at 2, 4, 6 months of age.",[64,65,66,67,68,30],"Diphtheria","Tetanus","Pertussis","Hepatitis B","Poliomyelitis","NOT_YET_RECRUITING","2024-09-26",{"date":72,"type":40},"2024-10-01",{"date":74,"type":22},"2024-10-02",{"date":76,"type":22},"2026-04-30",{"name":78,"class":47},"LG Chem",{"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":90,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":48},"100562637","safety-and-immunogenicity-of-dtap-ipvhib-pentavalent-vaccine-in-chinese-2-month-old-infants-100562637","NCT06605755","Safety and Immunogenicity of DTaP-IPV\u002FHib Pentavalent Vaccine in Chinese 2-month-old Infants","Extended Study on the Safety and Immunogenicity of DTaP-IPV\u002FHib Pentavalent Vaccine in Chinese 2-month-old Infants: a Randomized, Prospective, Open Clinical Study","Inclusion Criteria:\n\n\\- (1)Received 4 doses of DTaP-IPV\u002FHib pentavalent vaccines (2) Obtained consent from the participant's caregiver and sign an informed consent form\n\nExclusion Criteria:\n\n-(1) Diagnosed by a physician with a coagulation abnormality (e.g., coagulation factor deficiency, coagulopathy, platelet abnormality) (2) Any other factor considered to make participation in the trial unsuitable.","19 Months","22 Months",{"count":89,"type":22},785,[91],"NA","The main purpose of this study is to evaluate immune persistence at 30 and 36 Months of Age and Pertussis Breakthrough Infections between 19 and 36 Months of Age following two regiments of DTaP-IPV\u002FHib Pentavalent Vaccine in Healthy 2-Month-Old Infants and Children in China.",[66,64,65,30,94],"Polio","2024-09-18",{"date":97,"type":40},"2024-09-20",{"date":99,"type":40},"2024-09-05",{"date":101,"type":22},"2026-02",{"name":103,"class":104},"Jiangsu Province Centers for Disease Control and Prevention","NETWORK"]