[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CanSino Biologics Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":157},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,75,103,131],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100642701","a-clinical-trial-of-the-13-valent-pneumococcal-polysaccharide-conjugate-vaccine-crm197tetanus-toxoid-100642701",false,"NCT07648641","A Clinical Trial of the 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197\u002FTetanus Toxoid)","Phase IV Clinical Trial of the 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197\u002FTetanus Toxoid)","Inclusion Criteria:\n\n* Participants in the 2-month-old (minimum 6 weeks) group from the previous Phase III clinical trial of the 13-valent pneumococcal polysaccharide conjugate vaccine (CRM197, TT vector) (Protocol No.: CS-CTP-PCV)\n* The legal guardian or authorized representative is willing to provide identification documents\n* The legal guardian or authorized representative has provided informed consent, voluntarily signed the informed consent form, and is able to comply with the requirements of the clinical study protocol\n* The interval since the last dose of the primary vaccination series is ≥4 years\n\nExclusion Criteria:\n\n* Failure to complete blood draws at 1 and 2 years post-vaccination\n* Administration of any pneumonia vaccine after completion of the full vaccination series\n* Body temperature ≥37.3°C\n* Any other factors deemed by the investigator to render the participant unsuitable for participation in the clinical trial",true,"ALL","5 Years",{"count":20,"type":21},100,"ESTIMATED","OBSERVATIONAL","This clinical study will enroll 100 participants from the 2-month-old (minimum 6 weeks) group who previously participated in the Phase III clinical trial of the 13-valent pneumococcal polysaccharide conjugate vaccine (CRM197, TT vector) (Protocol No.: CS-CTP-PCV), with 50 participants in each of the treatment and control groups, and who have completed blood sample collection for the 1-year and 2-year immunogenicity studies. All participants will have 3.0-3.5 mL of venous blood collected for the immunogenicity study.",[25,26,27],"Pneumococcal Infections","Streptococcal Infections","Bacterial Infections",[29,30,25,31],"PCV13","13 valent Pneumococcal conjugate vaccine","Immune persistence","NOT_YET_RECRUITING","2026-06-10",{"date":35,"type":36},"2026-06-15","ACTUAL",{"date":38,"type":21},"2026-07-01",{"date":40,"type":21},"2027-12-01",{"name":42,"class":43},"CanSino Biologics Inc.","INDUSTRY",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":16,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100640277","phase-1-clinical-trial-of-the-24-valent-pneumococcal-polysaccharide-conjugate-vaccine-crm197tetanus-toxoid-100640277","NCT07600983","Clinical Trial of the 24-valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197\u002FTetanus Toxoid)","A Randomized, Blinded, Dose-Exploratory, Positive-Control Clinical Trial Evaluating the Safety and Immunogenicity of the 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197\u002FTetanus Toxoid) Following Administration in Individuals Aged 2 Months (Minimum 6 Weeks) and Older","Inclusion Criteria:\n\nPhase I:\n\n* Individuals aged 2 months (minimum 6 weeks), 7 months to 5 years, and 18 years and older who are willing to provide identification\n* The trial participant and\u002For guardian (legal representative) has voluntarily signed the informed consent form after providing informed consent\n* Children aged 5 and under who have not previously received a pneumococcal vaccine\n* People aged 18 and older who have not received a pneumonia vaccine in the past five years\n\nPhase II (age ≥50 group):\n\n* People aged 50 and older who are willing to provide identification documents\n* The trial participants voluntarily signed the informed consent form after providing their informed consent\n* People aged 50 and older who have not received a pneumonia vaccine in the past five years\n\nPhase II (2-month-old group (minimum 6 weeks)):\n\n* Individuals aged 2 months or older (minimum 6 weeks) who are willing to provide identification documents\n* The guardian (authorized representative) of the trial participant has voluntarily signed the informed consent form after providing informed consent.\n* Infants aged 2 months (minimum 6 weeks) who have not previously received a pneumococcal vaccine\n\nExclusion Criteria:\n\n* Exclusion criteria for the first dose:\n* Preterm birth (delivery before 37 weeks of gestation), low birth weight (\\\u003C2500 g at birth), history of labor abnormalities or resuscitation due to asphyxia; (Applicable to individuals in Phase I and Phase II who are 2 months of age or older (minimum 6 weeks))\n* Patients with abnormal results in pre-vaccination blood tests (including complete blood count, blood chemistry, and coagulation function) or urinalysis, which the investigator determines to be clinically significant; (Applicable only to Phase I participants aged 2 years (or 7 months) and older)\n* Individuals who are allergic to the active ingredient of the vaccine, any of its inactive ingredients, or substances used in the manufacturing process; or those who have previously experienced an allergic reaction after receiving a similar vaccine; Individuals with a history of severe allergic reactions to vaccines (such as acute allergic reactions, angioedema, or difficulty breathing), or a history of severe allergic reactions to any vaccine, food, or medication, including urticaria, anaphylactic shock, eczema, allergic respiratory distress, angioedema, or a history of asthma\n* Individuals with uncontrolled hypertension (as measured on-site: systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg); (Applicable to Stage II participants aged 50 and older and Stage I participants aged 18 and older)\n* Women of childbearing age with a positive urine pregnancy test; participants who are breastfeeding; or participants or their partners who plan to become pregnant within the next 6 months; (Applicable to the Phase II group aged 50 or older and the Phase I group aged 18 or older)\n* History of epilepsy, seizures (excluding febrile seizures), convulsions, or brain disorders \\[such as congenital brain malformations, traumatic brain injury, brain tumors, cerebral hemorrhage, cerebral infarction (excluding cerebral infarctions without sequelae and lacunar infarctions), brain infections, chemical poisoning, and other conditions causing damage to brain neural tissue\\], or a history of mental illness or a family history thereof; or those with other progressive neurological diseases\n* Have been diagnosed with a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases\n* Known or suspected acute illness or severe chronic disease (including severe respiratory disease, severe cardiovascular disease, liver or kidney disease, severe skin disease, malignant tumors, etc.); or currently experiencing an acute exacerbation of a chronic condition\n* Clinically diagnosed coagulation disorders (such as coagulation factor deficiencies, coagulation disorders, or platelet abnormalities) or significant bruising or bleeding disorders\n* Asplenia, functional asplenia, and asplenia or splenectomy resulting from any cause\n* Patients who have received immunosuppressive therapy within 6 months prior to vaccination or who are scheduled to receive such therapy between enrollment and 1 month after completion of the vaccination series (e.g., long-term systemic corticosteroid use for ≥14 days at a dose \\>2 mg\u002Fkg\u002Fday or ≥20 mg\u002Fday of prednisone or prednisone-equivalent dose) (excluding topical corticosteroids such as inhaled, nasal spray, intra-articular, eye drops, or ointments; topical use must not exceed the dose recommended in the product label or result in any signs of systemic exposure). Individuals who have used long-acting immunomodulatory drugs (e.g., infliximab) within 6 months prior to the first dose or who plan to use such drugs during the trial (applicable to the Phase II group aged ≥50 years and the Phase I group aged 7 months and older)\n* Received blood products (excluding hepatitis B immunoglobulin) within 3 months prior to receiving the investigational drug\n* Participation in any other clinical trial involving a drug or vaccine within the 6 months prior to enrollment, or currently participating in such a trial, or plans to participate in such a trial during the study period\n* Received an injectable live attenuated vaccine within 14 days prior to receiving the investigational drug, or received any other vaccine within 7 days\n* Underarm temperature of 37.3°C or higher prior to vaccination\n* According to the researchers' assessment, the trial participants had other factors that made them unsuitable for participation in the clinical trial\n\nExclusion criteria for the 2nd, 3rd, and 4th doses:\n\n* Individuals who experienced a severe allergic reaction following the previous dose of the vaccine\n* Individuals who experienced a serious adverse reaction causally related to a previous dose of the vaccine\n* Other potential causes ruled out by the researchers","6 Weeks",{"count":53,"type":21},854,"INTERVENTIONAL",[56,57],"PHASE1","PHASE2","This clinical trial consists of Phase I and Phase II. The objective is to evaluate the safety and immunogenicity of the 24-valent pneumococcal polysaccharide conjugate vaccine (CRM197\u002Ftetanus toxoid) in individuals aged 2 months (minimum 6 weeks) and older.",[60],"Streptococcus Pneumoniae Infection",[62,63,64,65,66],"Vaccine","Individuals aged 2 months (minimum 6 weeks) and older","Polysaccharide binding","Safety","Immunogenicity","2026-05-15",{"date":69,"type":36},"2026-05-22",{"date":71,"type":21},"2026-05-24",{"date":73,"type":21},"2027-12-30",{"name":42,"class":43},{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":16,"sex":17,"minAge":51,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":54,"phases":85,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100594310","phase-3-a-study-to-evaluate-the-immunogenicity-and-safety-of-13-valent-pneumococcal-conjugate-vaccine-pcv13i-in-healthy-infants-aged-2-months-minimum-6-weeks-100594310","NCT07017777","A Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infants Aged 2 Months (Minimum 6 Weeks)","A Phase III, Observer-blind, Randomized Controlled Trial to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infants Aged 2 Months (Minimum 6 Weeks)","Inclusion Criteria:\n\n* Healthy infants with stable clinical conditions aged 2 months (42-90 days) at the time of screening, based on medical history and clinical assessment by the investigator. Infants will be eligible starting from the day they turn 6 weeks of age.\n* Infant's parent or legal guardian must be able and willing to provide informed consent for the infant's participation in the study.\n* Participants and their parent or legal guardian must demonstrate the ability to comply with all trial procedures and be available for the entire follow-up duration.\n* The infant's parent or legal guardian must have an easily identifiable and stable place of residence within the study area, be available for the duration of trial participation, and have access to a reliable means of telephone contact for communication with the study team.\n\nExclusion Criteria for the first dose:\n\n* Infants born at \\\u003C35 weeks of gestation.\n* Infants who have previously received any pneumococcal vaccine.\n* Infants currently participating in or who have recently participated in another interventional clinical trial.\n* Infants with an axillary temperature of ≥37.8°C at the time of enrollment (the participant must be deferred until recovery. The visit may be rescheduled when this criterion is met.)\n* Infants with any congenital abnormalities, chronic medical conditions, or genetic disorders, severe malnutrition, inherited disease and others, that in the investigator's judgment, may interfere with the study outcomes.\n* History of anaphylactic shock\n* History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the experimental and control vaccine\n* History of epilepsy and convulsions.\n* Have received immunosuppressive treatment, cytotoxic treatment, systemic steroid treatment for more than 2 weeks, etc. (excluding local treatment, surface treatment of acute non-concurrent dermatitis, or spray treatment of allergic rhinitis).\n* Received or planned to receive blood\u002Fplasma products or immunoglobulins throughout the study period or prior to study vaccination.\n* History of coagulation disorders or blood conditions that could cause anemia or excess bleeding as judged by the investigator.\n* Infants with known or suspected immunodeficiency, as determined by medical history and\u002For physical examination.\n* Administration of other vaccines within 7 days prior to enrollment.\n* Any history or current evidence of a condition or therapy that could confound study results, interfere with participation, or is not in the best interest of the participant, as judged by the investigator.\n* The participant is a direct descendant (child or grandchild) of any person employed by the Sponsor, the contract research organization (CRO), the investigator, or study site personnel.\n* Any other condition or situation that, in the investigator's judgment, might interfere with the study or pose additional risks to the participant.\n\nIndividual termination criteria for subsequent doses:\n\n* Severe allergic reaction after the previous vaccination.\n* Serious adverse events caused by the previous vaccination that is not suitable for subsequent vaccination(s) as judged by the investigator.\n* Newly identified symptoms or newly occurred cases after the first vaccination that do not meet the inclusion criteria for the first dose, or that meet the exclusion criteria for the first dose. The decision to discontinue participation is determined by the investigator.\n* Other reasons for exclusion considered by the investigator.","2 Months",{"count":84,"type":21},600,[86],"PHASE3","This is a Phase 3 randomized, observation-blinded, active-controlled, parallel-group clinical trial designed to evaluate the immunogenicity, safety, and functional antibody response of the experimental vaccine versus the control vaccine in healthy Thailand infants vaccinated at a 2+1 schedule (2 months, 4 months and 12-15 months). The trial will enroll approximately 600 healthy infants aged 2 months (at least 6 weeks) who will be randomly assigned in a 1:1 ratio to receive either the experimental or control vaccine, with 100 in each group (200 in total) randomized to subgroups and subject to additional immunogenicity assessments. All participants will be evaluated for solicited adverse events for 7 days and unsolicited adverse events for 30 days post each vaccination. Immunogenicity evaluation will be performed in all participants at baseline and post the booster dose, while the sub-cohort participants will be evaluated for post primary series immunogenicity additionally.",[25,26,27],[90,30,91,92,65,66],"PCV13i","Pneumococcal infections","2 months of age","RECRUITING","2026-02-25",{"date":96,"type":36},"2026-02-27",{"date":98,"type":36},"2025-11-14",{"date":100,"type":21},"2028-05-15",{"name":42,"class":43},3,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":16,"sex":17,"minAge":82,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":54,"phases":113,"briefSummary":114,"conditions":115,"keywords":119,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},"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.","6 Years",{"count":112,"type":21},260,[56],"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.",[116,117,118],"Diphtheria, Tetanus and Acellular Pertussis","Epidemic Meningitis","Haemophilus Influenzae Type B Infection",[120,65,66,121],"Combined Vaccine","Ages 2 months to 6 years","2025-12-25",{"date":124,"type":36},"2025-12-31",{"date":126,"type":36},"2025-12-19",{"date":128,"type":21},"2029-02",{"name":42,"class":43},1,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":16,"sex":17,"minAge":51,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":54,"phases":141,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":130},"100560450","phase-1-a-study-to-evaluate-the-safety-and-immunogenicity-of-vlp-polio-in-infants-and-toddlers-100560450","NCT06577298","A Study to Evaluate the Safety and Immunogenicity of VLP-Polio in Infants and Toddlers","A Phase I\u002FII Randomized, Double-blind, Positive-controlled Dose-exploration Study to Evaluate the Safety and Immunogenicity of a Virus-like Particle (VLP) Based Vaccine Against Poliomyelitis (VLP-Polio) in Infants From 6 Weeks of Age and Toddlers 12-18 Months of Age","Inclusion Criteria:\n\n* Healthy toddlers aged 12-18 months at the time of screening, and have completed primary immunization of polio vaccine according to the national government program in the first year of life.\n* Healthy infants aged 6 weeks to 2 months (42 to 98 days, with the day of birth considered day of life 1), and who have not received any polio vaccines.\n* Able to obtain written informed consent from parent(s) or legal guardian(s).\n* Participants and their parents or legal guardian(s) can comply with trial procedures, are available for the duration of follow-up, and have a suitable telephone contact available.\n\nExclusion Criteria:\n\nExclusion criteria for the first dose:\n\n* Current polio disease or history of polio disease.\n* Toddlers who have an interval of less than 5 months since their last dose of the polio vaccine.\n* Infants born at \\\u003C 37 weeks of gestation.\n* Children with a birth weight \\\u003C 2500g and a body weight \\\u003C 3500g at the time of enrollment.\n* Body temperature ≥37.5°C (the visit may be rescheduled when this criterion is met).\n* Have congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.\n* Any moderate or severe acute illness.\n* Any abnormal vital signs.\n* History of epilepsy, convulsions, or parent with congenital cognitive disability, dementia, or intellectual disabilities.\n* Have received immunosuppressive treatment, cytotoxic treatment, glucocorticoid treatment, etc. (excluding local treatment, surface treatment of acute non-concurrent dermatitis, or spray treatment of allergic rhinitis).\n* Received or plan to receive blood\u002Fplasma products or immunoglobulins throughout the study period or prior to study vaccination.\n* History of serious adverse events and\u002For severe allergic reactions (e.g., systemic allergic reactions) to any component of the study vaccine.\n* History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding (e.g., thalassemia, coagulation factor deficiencies, severe anemia at birth).\n* Immunocompromised individuals with known or suspected immunodeficiency as determined by medical history and\u002For physical examination (e.g., history of pancreatic, liver, spleen, kidney disease or history of resection).\n* Administration of other vaccines within 7 days.\n* Participation in other interventional studies within 28 days prior to screening and\u002For during study participation.\n* Household member or sibling who has received or is scheduled to receive OPV in the previous 3 months until 5 weeks after the third dose of the primary immunization series.\n* The participant is a direct descendant (child or grandchild) of any person employed by the Sponsor, the contract research organization (CRO), the investigator, or study site personnel.\n* History or current evidence of any condition or therapy which might confound the results of the study, interfere with the participant's participation for the full duration of the study, indicate suspected diseases, or is not in the best interest of the participants to participate, in the opinion of the treating investigator.\n* Family history of any medical conditions, that in the investigating doctor's opinion, could affect the trial outcomes.\n* Any reason or condition the investigator considers sufficient to make a participant ineligible for participation in the study.\n\nExclusion criteria for the subsequent doses:\n\n* Severe allergic reaction after the previous vaccination.\n* Serious adverse events caused by the previous vaccination.\n* Newly identified symptoms or newly occurred cases after the first vaccination that do not meet the inclusion criteria for the first dose, or that meet the exclusion criteria for the first dose. The decision to discontinue participation is determined by the investigator.\n* Other reasons for exclusion considered by the investigating doctor .","18 Months",{"count":140,"type":21},480,[56,57],"This is a phase I\u002FII randomized, double-blind, and positive-controlled study. Participants in the phase I toddler group will receive 1 dose of either high dose VLP-Polio (Dose H) or control vaccine in a ratio of 3:1. The phase I infant cohort will have 4 arms randomly assigned to receive either investigational vaccine (Low-adjuvant dose VLP-Polio, Medium dose VLP-Polio, or High dose VLP-Polio or control vaccine in a ratio of 3:1. Phase II infant cohort will have 4 arms randomly assigned to receive either investigational vaccine (Low-adjuvant dose VLP-Polio, Medium dose VLP-Polio, or High dose VLP-Polio or control vaccine in a ratio of 3:1. Each infant participant will be administrated 3 doses of the assigned vaccine with 28 days apart, and the booster dose will be given when the infant is 12-18 months old. Enrollment of Phase I and Phase II will be staggered in descending order of age group but ascending order of dosing levels. Blood and mucosal samples will be collected for immunogenicity evaluation over the time course of the study.",[144],"Poliomyelitis",[62,146,66,65,147,148],"Trivalent","12-18 months toddlers","2 months infants","2025-07-02",{"date":151,"type":36},"2025-07-04",{"date":153,"type":36},"2024-12-19",{"date":155,"type":21},"2026-12",{"name":42,"class":43},""]