[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"poliomyelitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:poliomyelitis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,48,73,95,122,143,170,198,227,253],{"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":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100489541","phase-2-study-of-a-novel-type-3-oral-poliomyelitis-vaccine-in-panama-100489541",false,"NCT05654467","Study of a Novel Type 3 Oral Poliomyelitis Vaccine in Panama","A Phase 2, Randomized, Observer-Blind, Controlled, Age De-escalation, Dosage Escalation Study to Assess the Safety and Immunogenicity of a Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine in Healthy Young Children, Infants, and Neonates in Panama","Inclusion Criteria\n\nInclusion Criteria for all participants:\n\n1. Healthy, as defined by the absence of any clinically significant medical condition or congenital anomaly as determined by medical history, physical examination, and clinical assessment of the investigator.\n2. Parent(s) or guardian(s) willing and able to provide written informed consent prior to performance of any study-specific procedure.\n3. Resides in study area and parent(s) or guardian(s) understands and is able and willing to adhere to all study visits and procedures (as evidenced by a signed informed consent form \\[ICF\\] and assessment by the investigator).\n4. Parent(s) or guardian(s) agrees for participant to receive all routine infant and childhood immunizations as per the approved protocol adjusted schedule.\n\nInclusion Criteria for cohort 1 participants only:\n\n1. Male or female child from ≥1 to \\\u003C5 years-of-age at the time of initial study vaccination.\n2. Based on available documentation or parental\u002Fguardian(s) report, previously completed the primary poliomyelitis immunization series for the jurisdiction, with last dose received more than 28 days prior to initial study vaccination.\n\nInclusion Criteria for cohort 2 participants only:\n\n1. Male or female infant expected to be 6 weeks of age (43rd to 49th day of life \\[with day of birth being the first day of life\\], inclusive + 6 day window), at the time of initial study vaccination.\n2. Prior to study vaccination has received no doses of IPV or OPV, based on no evidence of such vaccination per available parental\u002Fguardian(s) report or documentation.\n\nInclusion Criteria for Cohort 3 participants only:\n\n1. Male or female newborn (1st day of life + 3-day window), at the time of initial study vaccination.\n2. Prior to study vaccination has received no doses of IPV or OPV vaccine, based on no evidence of such vaccination per available parental\u002Fguardian(s) report or documentation.\n\nExclusion Criteria\n\nExclusion Criteria for all participants:\n\n1. For all participants the presence of anyone under 10 years of age in the participant's household (living in the same house or apartment unit) who does not have complete \"age appropriate\" vaccination status with respect to poliovirus vaccines at the time of study vaccine administration. For household members younger than 10 years of age appropriate vaccination is complete series of the primary poliomyelitis immunization series for the jurisdiction.\n2. For all participants having a member of the participant's household (living in the same house or apartment unit) who has received OPV based on the vaccination records in the previous three months before study vaccine administration.\n3. Any participating children attending day care or pre-school during their participation in the study until one month after their last study vaccine administration.\n4. Moderate or severe (grade ≥ 2) acute illness at the time of enrollment\u002Ffirst study vaccination-temporary exclusion (see Appendix II: Severity Grading Tables). Participant with mild (grade 1) acute illnesses may be enrolled at the discretion of the investigator.\n5. Presence of fever on the day of enrollment\u002Ffirst study vaccination (axillary temperature\n\n   ≥37.5˚C)-(Temporary exclusion for cohorts 1 and 2). If resolved in 48 hrs., can be enrolled.\n6. A known allergy, hypersensitivity, or intolerance to any components of the study vaccines, including all macrolide and aminoglycoside antibiotics (e.g., erythromycin and kanamycin).\n7. Any self-reported known or suspected immunosuppressive or immunodeficiency condition (including HIV infection) in the participant or household member (living under the same roof\u002Fin the same building rather than in the same compound).\n8. Receipt of any systemic immune-modifying or immunosuppressant drugs prior to the first study vaccine dose or planned use during the study of study participants or a household member.\n9. Any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection.\n10. Presence of severe malnutrition (weight-for-length\u002Fheight z-score ≤-3SD median \\[per WHO published child growth standards\\])-temporary exclusion if marginal and subsequently gains weight.\n11. Participation in another investigational product (drug or vaccine) clinical trial within 30 days prior to entry in this study or receipt of any such investigational product other than the study vaccine within 30 days prior to the first administration of study vaccine, or planned use during the study period.\n12. Receipt of transfusion of any blood product or immunoglobulins within 12 months prior to the first administration of study vaccine or planned use during the study period.\n13. Parent(s) or guardian(s) or participant has any condition that in the opinion of the investigator would increase the participant's health risks in study participation or would increase the risk of not achieving the study's objectives (e.g., would compromise adherence to protocol requirements or interfere with planned safety and immunogenicity assessments).\n\nExclusion Criteria for cohort 2 and 3 participants only:\n\n1. Premature birth (less than 37 weeks gestation or less than 2500 grams birth weight).\n2. From multiple birth (due to increased risk of OPV transmissions between siblings).",true,"ALL","1 Day","4 Years",{"count":21,"type":22},1532,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The purpose of this clinical trial is to assess the safety and tolerability (primary objective), immunogenicity (primary and secondary objectives), fecal shedding of vaccine viruses (secondary objective) and the potential for neurovirulence of shed virus (secondary objective) of a novel oral polio type 3 vaccine, nOPV3, as compared to Sabin monovalent type 3 vaccine controls (mOPV3), in healthy young children (192 subjects), infants (860 subjects), and neonates (480 subjects).",[28],"Poliomyelitis",[30,31,32,33,34],"Vaccine tolerability","Vaccine safety","Vaccine reactogenicity","Vaccine viral shedding","Vaccine immunogenicity","RECRUITING","2026-05-06",{"date":38,"type":39},"2026-05-11","ACTUAL",{"date":41,"type":39},"2023-12-05",{"date":43,"type":22},"2027-03-20",{"name":45,"class":46},"PATH","OTHER",3,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":16,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":47},"100628086","phase-4-phase-iv-clinical-study-of-sequential-vaccination-of-sabin-strain-and-wild-strain-inactivated-poliovirus-vaccine-100628086","NCT07457060","Phase IV Clinical Study of Sequential Vaccination of Sabin Strain and Wild Strain Inactivated Poliovirus Vaccine","An Open-labelled, Randomized, Controlled, Clinical Trial to Evaluate the Immunogenicity and Tolerability of Sequential Vaccination of Sabin Strain and Wild Strain Inactivated Poliovirus Vaccine","Inclusion Criteria:\n\n1. Infants of 2 months old (aged 56-84 days).\n2. Have a parent\u002Flegal guardian who has provided written informed consent after being fully informed about the study.\n3. Be able to provide the vaccination records since birth.\n4. The infant's mother is tested negative for HIV, syphilis, hepatitis B, and hepatitis C during or before the infant's enrollment to this study (test results obtained during pregnancy are acceptable, if provided).\n\nExclusion Criteria:\n\n1. History of any polio vaccination.\n2. History of severe allergic reaction to previous vaccinations or hypersensitivity to any vaccine component.\n3. Premature infants (born before week 37 of gestation).\n4. History of asphyxia rescue or nervous system injury.\n5. Congenital malformations, developmental disorders, clinically significant genetic defects, severe malnutrition.\n6. Autoimmune diseases or immunodeficiency\u002Fimmunosuppression.\n7. Serious chronic diseases such as Down's syndrome, diabetes, sickle cell anemia, or neurological disorders.\n8. Abnormal coagulation functions (e.g., coagulation factor deficiency, blood coagulation diseases, platelet disorders).\n9. Received immunosuppressant (excluding topical or inhaled corticosteroids), cytotoxic drug, or other immunomodulatory therapies.\n10. Received blood products before trial vaccine inoculation.\n11. Received other study drugs within 30 days before enrollment.\n12. Received live attenuated vaccines within 14 days before enrollment.\n13. Received subunit or inactivated vaccines within 7 days before enrollment.\n14. Acute diseases or acute exacerbations of chronic diseases within 7 days before enrollment.\n15. Significant acute diseases, chronic infections, or axillary temperature ≥ 37.5°C before enrollment.\n16. Any other factors deemed by the investigators as unsuitable for participation.","56 Days","84 Days",{"count":58,"type":22},480,[60],"PHASE4","The goal of this study is to compare the immunogenicity and safety of sIPV administered via subcutaneous and intramuscular injection routes",[28],"2026-03-03",{"date":65,"type":39},"2026-03-09",{"date":67,"type":39},"2025-11-27",{"date":69,"type":22},"2026-10-19",{"name":71,"class":72},"Sinovac Biotech Co., Ltd","INDUSTRY",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":16,"sex":17,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":47},"100620180","phase-4-phase-iv-clinical-study-of-sipv-administration-in-adolescent-and-adult-populations-100620180","NCT07354269","Phase IV Clinical Study of sIPV Administration in Adolescent and Adult Populations","Phase IV Clinical Study Comparing the Immunogenicity and Safety of a Single-dose Poliomyelitis Vaccine (Vero Cells), Inactivated, Sabin Strains (sIPV) in Adolescents and Adults Aged 7-50 Years Versus the Primary Immunization With DTaP-IPV-Hib Pentavalent Vaccine in Infants Aged 3 Months","Inclusion Criteria:\n\n1. Healthy adolescents and adults aged 7-50 years, and healthy infants aged 3 months;\n2. Participants and\u002For their guardians are able to understand and voluntarily sign the informed consent form (for participants aged 7-17 years, both the participant and their guardian need to sign);\n3. Provide valid proof of identity;\n4. Willing and able to comply with all visit schedules, sample collections, vaccinations, and other study procedures, and remain contactable throughout the study period;\n5. Fertile participants and their sexual partners voluntarily adopt effective contraceptive measures from the signing of the informed consent form until 3 months after vaccination with the study vaccine, and have no plans to donate sperm or eggs.\n\nExclusion Criteria:\n\n1. Known history of polio\u002Fpolio infection.\n2. Exposure or suspected exposure to pertussis, diphtheria, and tetanus within the past 30 days, such as having a confirmed case of pertussis or diphtheria in the household (applies to infants aged 3 months).\n3. History of uncontrolled chronic or severe illnesses, including but not limited to cardiovascular disease, hematological disorders, liver and kidney diseases, digestive system diseases, respiratory diseases, malignant tumors, and history of major organ transplantation.\n4. Presence of autoimmune diseases, immunodeficiency disorders (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection).\n5. Abnormal coagulation function (such as coagulation factor deficiency, platelet abnormalities).\n6. Premature birth (delivery before the 37th week of gestation) or low birth weight (birth weight \\\u003C2500g), or history of asphyxiation, or history of neurological damage (applies to infants aged 3 months).\n7. Severe congenital malformations, genetic defects, and malnutrition.\n8. Current or past history of severe neurological diseases (epilepsy, convulsions or seizures \\[excluding a history of febrile seizures\\]) or psychiatric disorders, or family history of psychiatric disorders.\n9. Acute exacerbations of various acute or chronic diseases within the past 3 days, or known or suspected active infections.\n10. History of vaccination with any vaccine containing DTP, IPV, Hib components, or pneumococcal polysaccharide conjugate vaccine (applies to infants aged 3 months).\n11. Received immunosuppressive or other immunomodulatory treatment for ≥14 days within the past 6 months (≥20mg\u002Fday of prednisone for those ≥18 years old, ≥2mg\u002Fkg\u002Fday for those \\\u003C18 years old, or equivalent doses), cytotoxic treatment, or plans to receive such treatment during the study.\n12. Received immunoglobulin or other blood products within the past 6 months, or plans to receive such treatment during the study.\n13. Received other investigational drugs or vaccines within the past 30 days, or plans to receive such drugs or vaccines during the study.\n14. Received live attenuated vaccines, nucleic acid vaccines within the past 14 days, or subunit or inactivated vaccines within the past 7 days.\n15. Known allergy to any component of the study vaccine (inactivated poliovirus, 199 medium, glycine, sodium chloride, potassium chloride, calcium chloride, magnesium phosphate, disodium phosphate, monosodium phosphate \\[for adolescents and adults\\]; inactivated poliovirus, diphtheria toxoid, tetanus toxoid, pertussis toxoid, pertussis filamentous hemagglutinin, Haemophilus influenzae type b capsular polysaccharide, tetanus protein conjugate \\[for infants aged 3 months\\]).\n16. Breastfeeding, pregnant, or planning to become pregnant within 3 months after vaccination in this study (applies only to adolescents and adults).\n17. Axillary temperature \\>37.0°C before vaccination on the day of the planned vaccination with the study vaccine.\n18. Unqualified physical examination results on the day of the planned vaccination with the study vaccine.\n19. Skin injuries, inflammation, ulcers, rashes, scars, or other conditions at the intended injection site that may interfere with vaccination or observation of local reactions.\n20. Any other factors deemed unsuitable for participation in the clinical study by the investigator.","3 Months","50 Years",{"count":83,"type":22},180,[60],"The goal of this clinical study is to compare the immunogenicity and safety of one dose of sIPV in adolescents or adults aged 7-50 years with that of three doses of DTaP-IPV-Hib Pentavalent Vaccine in Infants Aged 3 Months",[28],"2026-01-14",{"date":89,"type":39},"2026-01-21",{"date":91,"type":39},"2025-09-26",{"date":93,"type":22},"2026-05-02",{"name":71,"class":72},{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":16,"sex":17,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":23,"phases":107,"briefSummary":108,"conditions":109,"keywords":110,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":47},"100584909","phase-2-study-of-co-administered-types-1--2-novel-oral-poliomyelitis-vaccines-evaluation-100584909","NCT06895486","Study of Co-administered (Types 1 & 2) Novel Oral Poliomyelitis Vaccines Evaluation","A Phase 2, Randomized, Double- Dummy, Observer-Blind Study to Evaluate the Safety and Immunogenicity of Co-administered Novel Live Attenuated Monovalent Oral Poliomyelitis Vaccines in Healthy Young Infants Relative to Monovalent Vaccines Alone in Panama.","SCOPE","Inclusion Criteria:\n\n1. Healthy male or female infant 16 weeks (+ 7 days) of age, at the time of first study vaccination. Healthy as defined by the absence of any clinically significant medical condition or congenital anomaly as determined by medical history, physical examination, and clinical assessment by the investigator.\n2. Parent(s) willing and able to provide written informed consent prior to performance of any study-specific procedure.\n3. Resides in study area and parent understands and is able and willing to adhere to all study visits and procedures (as evidenced by a signed informed consent form (ICF) and assessment by the investigator).\n4. Prior to study vaccination has received EPI vaccines as per the study EPI schedule and has received a single dose of IPV at 6 weeks (+7 days) of age.\n5. Prior to study vaccination has received no doses of OPV, based upon no evidence of such vaccination per available documentation.\n6. Parent agrees for participant to receive routine infant and childhood immunizations as per the approved protocol-adjusted schedule.\n\nExclusion Criteria:\n\n1. Presence of anyone under 10 years of age in the participant's household (living in the same house or apartment unit) who does not have complete age appropriate vaccination status (as per local guidelines) with respect to poliovirus vaccines at the time of study vaccine administration.\n2. Member of the participant's household (living in the same house or apartment unit) who has received OPV based on the vaccination records in the previous 3 months before study vaccine administration. Participants from household where a member received investigational nOPV3 vaccine will also be excluded from the study.\n3. Low birth weight (LBW), defined as a birth weight of less than 2500 g (up to and including 2499 g) at the time of birth.\n4. Premature birth (less than 37 weeks gestation).\n5. From multiple births (due to increased risk of OPV transmissions between siblings).\n6. Moderate or severe (grade ≥ 2) acute illness at the time of eligibility\u002Ffirst study vaccination - temporary exclusion. Note: Participants with mild (grade 1) acute illnesses may be considered eligible at the discretion of the investigator.\n7. Presence of fever on the day of randomization\u002Ffirst study vaccination (axillary temperature ≥37.5˚C) - temporary exclusion.\n8. Presence of abnormal vital signs (respiratory rate and\u002For heart rate) for age on the day of randomization\u002Ffirst study vaccination - temporary exclusion.\n9. A known allergy, hypersensitivity, or intolerance to any components of the study vaccines, including all macrolide and aminoglycoside antibiotics (e.g., erythromycin and kanamycin).\n10. Any reported known or suspected immunosuppressive or immunodeficiency condition (including HIV infection) in the participant or household member. Topical and inhaled steroids are permitted.\n11. Receipt of any immune-modifying or immunosuppressant drugs prior to the first study vaccine dose or planned use during the study of study participants or a household member. Topical and inhaled steroids are permitted.\n12. Any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection.\n13. Presence of severe malnutrition (weight-for- length\u002Fheight z-score \\\u003C-3SD median \\[per WHO published child growth standards\\]) - temporary exclusion if marginal and subsequently gains sufficient weight to attain z-score ≥-3 SD.\n14. Receipt of any investigational product prior to the first administration of study vaccine, or planned use during the study period.\n15. Receipt of rotavirus vaccine within 2 weeks prior to first study vaccination.\n16. Prior receipt of an investigational product containing poliovirus vaccine.\n17. Receipt of transfusion of any blood product or immunoglobulins prior to the first administration of study vaccine or planned use during the study period.\n18. Parent or participant has any condition that in the opinion of the investigator would increase the participant's health risks in study participation or would increase the risk of not achieving the study's objectives (e.g., would compromise adherence to protocol requirements or interfere with planned safety and immunogenicity assessments).","6 Weeks","7 Weeks",{"count":106,"type":22},675,[25],"The purpose of this study is to evaluate the safety and tolerability of co-administration of nOPV1 + nOPV2 in infants, relative to those receiving monovalent nOPV vaccines alone and whether two and\u002For three doses of co-administered nOPV1 and nOPV2 are non-inferior to corresponding doses of nOPV1 alone and nOPV2 alone.",[28],[111,112,28,113],"Vaccine","Polio","novel oral polio vaccine","2026-01-07",{"date":116,"type":39},"2026-01-09",{"date":118,"type":39},"2025-11-11",{"date":120,"type":22},"2026-12-28",{"name":45,"class":46},{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":16,"sex":17,"minAge":129,"maxAge":19,"enrollmentInfo":130,"targetDuration":4,"studyType":23,"phases":132,"briefSummary":133,"conditions":134,"keywords":135,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":136,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},"100488751","phase-2-study-of-a-novel-type-1-oral-poliomyelitis-vaccine-in-bangladesh-100488751","NCT05644184","Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh","A Phase 2, Randomized, Observer-blind, Controlled, Age De-escalation, Dosage Escalation Study to Assess Safety and Immunogenicity of a Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine in Healthy Young Children, Infants, and Neonates in Bangladesh","Inclusion Criteria for all participants:\n\n1. Healthy, as defined by the absence of any clinically significant medical condition or congenital anomaly as determined by medical history, physical examination, and clinical assessment of the investigator\n2. Parent(s) or guardian(s) willing and able to provide written informed consent prior to performance of any study-specific procedure\n3. Resides in study area and parent understands and is able and willing to adhere to all study visits and procedures (as evidenced by a signed informed consent form \\[ICF\\] and assessment by the investigator)\n4. Parent agrees for participant to receive all routine infant and childhood immunizations as per the approved protocol-adjusted schedule\n\nInclusion Criteria for Cohort 1 (young children) participants only:\n\n1. Male or female child from 1 to less than 5 years of age at the time of initial study vaccination\n2. Based on documentation, previously received a 3 or 4 dose primary poliomyelitis immunization series containing OPV (may have also received IPV), with last dose received more than 3 months prior to initial study vaccination\n\nInclusion Criteria for Cohort 2 (infants) participants only:\n\n1. Male or female infant expected to be 6 weeks of age (43rd to 49th day of life \\[with day of birth being the first day of life\\], inclusive+ 6-day window), at the time of initial study vaccination\n2. Prior to study vaccination has received no doses of IPV or OPV, based on no evidence of such vaccination per available documentation.\n\nInclusion Criteria for Cohort 3 (neonates) participants only:\n\n1. Male or female newborn (1st day of life+ 3-day window, inclusive), at the time of initial study vaccination\n2. Prior to study vaccination has received no doses of IPV or OPV or rotavirus vaccine, based on no evidence of such vaccination per available documentation.\n\nExclusion Criteria for all participants:\n\n1. For all participants, the presence of anyone under 10 years of age in the participant's household (living in the same house or apartment unit) who does not have complete \"age appropriate\" vaccination status with respect to poliovirus vaccines at the time of study vaccine administration. For household members younger than 10 years of age, \"age appropriate\" vaccination is complete series of trivalent Oral Poliovirus Vaccine (tOPV) or at least three doses of bivalent (types 1 and 3) Oral Poliovirus Vaccine (bOPV) plus a booster fractional dose of IPV (fractional dose Inactivated Polio Vaccine; fIPV). Note: A vaccination series of tOPV or at least three doses of bOPV with our without a booster fractional dose of IPV will be considered sufficient.\n2. For all participants, having a member of the participant's household (living in the same house or apartment unit) who has received OPV based on the vaccination records in the previous 3 months before study vaccine administration.\n3. Any participating children attending day care or pre-school during their participation in the study until one month after their last study vaccine administration.\n4. Moderate or severe (grade ≥ 2) acute illness at the time of enrollment\u002Ffirst study vaccination - temporary exclusion. Participant with mild (grade 1) acute illnesses may be enrolled at the discretion of the investigator.\n5. Presence of fever on the day of enrollment\u002Ffirst study vaccination (axillary temperature ≥37.5˚C) - (Temporary exclusion for Cohorts 1 and 2)\n6. A known allergy, hypersensitivity, or intolerance to any components of the study vaccines, including all macrolide and aminoglycoside antibiotics (e.g., erythromycin and kanamycin)\n7. Evidence of a clinically significant congenital or genetic defect as judged by the investigator\n8. History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids (\\> 0.5mg\u002Fkg\u002Fday of prednisolone (or equivalent)). Topical and inhaler steroids are permitted (unless indicative of a significant chronic illness otherwise excluding the infant\u002Fyoung child)\n9. Any self-reported known or suspected immunosuppressive or immunodeficiency condition (including HIV infection) in the participant or household member (living under the same roof\u002Fin the same building rather than in the same compound)\n10. Receipt of any immune-modifying or immunosuppressant drugs within 6 months prior to the first study vaccine dose or planned use during the study of study participants or a household member\n11. Any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection\n12. Presence of sever malnutrition \\[weight-for-length\u002Fheight z-score greater than or equal to -3 SD median (per WHO published growth standards)\\] - temporary exclusion if marginal and subsequently gains weight.\n13. Participation in another investigational product (drug or vaccine) clinical trial within 30 days prior to entry in this study or receipt of any such investigational product other than the study vaccine within 30 days prior tot he first administration of study vaccine, or planned use during the study period.\n14. Receipt of transfusion of any blood product or immunoglobulins within 12 months prior to the first administration of study vaccine or planned use during the study period.\n15. Parent or participant has any condition that in the opinion of the investigator would increase the participant's health risks in the study participation or would increase the risk of not achieving the study's objectives (e.g., would compromise adherence to protocol requirements or interfere with planned safety and immunogenicity assessments.)\n\nExclusion Criteria for Cohort 2 \\& 3 participants only:\n\n1. Low birth weight (LBW) in newborn participants which is defined as a birth weight of less than 2500g (up to and including 2499b) at the time of birth or by the time of enrolment.\n2. Premature birth (less than 37 weeks gestation)\n3. From multiple birth (due to increased risk of OPV transmission between siblings)","0 Days",{"count":131,"type":22},2232,[25],"The purpose of this clinical trial is to assess the safety and tolerability (primary objective), immunogenicity (primary and secondary objectives), fecal shedding of vaccine viruses (secondary objective) and the potential for neurovirulence of shed virus (secondary objective) of a novel oral polio type 1 vaccine, nOPV1, as compared to Sabin monovalent type 1 vaccine controls (mOPV1), in healthy young children (192 subjects), infants (720 subjects), and neonates (1320 subjects).",[28],[30,31,32,33,34],{"date":116,"type":39},{"date":138,"type":39},"2023-03-27",{"date":140,"type":22},"2026-05-15",{"name":45,"class":46},1,{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":150,"enrollmentInfo":151,"targetDuration":4,"studyType":23,"phases":153,"briefSummary":155,"conditions":156,"keywords":157,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":142},"100593775","phase-3-a-study-to-evaluate-the-mucosal-intestinal-immunity-to-poliovirus-type-2-of-nopv2-at-birth-dose-in-healthy-ipv-vaccinated-infants-100593775","NCT07010822","A Study to Evaluate the Mucosal Intestinal Immunity to Poliovirus Type-2 of nOPV2 at Birth Dose in Healthy IPV Vaccinated Infants","A Phase III, Double-blind, Randomized, Placebo Controlled Study to Evaluate the Mucosal Intestinal Immunity to Poliovirus Type-2 of nOPV2 at Birth Dose in Healthy IPV Vaccinated Infants","Inclusion Criteria:\n\n1. Newborn infants of maximum 1 week of age with birth weight \\> 2,500 g.\n2. Healthy infants without obvious medical conditions like immunodeficiency diseases, severe congenital malformations, severe neurological diseases or any other disease that require high doses of corticosteroids or immunotherapies that preclude the subject from participating in the study as established by medical history and physical examination.\n3. Written informed consent obtained from both parents or legal guardian(s) as per country regulations.\n4. Resides in the area and parents willing to adhere to all study procedures.\n\nExclusion Criteria:\n\n1. Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the participant's household.\n2. Household member who has receive any novel OPV 1 month before birth of this study's participant up through 1 month post-last-dose.\n3. Family history of congenital or hereditary immunodeficiency.\n4. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).\n5. Known allergy to any component of the study vaccines or to any antibiotics that share molecular composition with a component of the study vaccines.\n6. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections (of IPV)\n7. Administration of immunoglobulins and\u002For any blood products since birth or planned administration during the study period.\n8. Acute severe febrile illness (≥37.5 °C) on the day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all inclusion criteria are met.).\n9. Participant who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the participant.\n10. Infants from multiple births or born prematurely (\\\u003C 37 weeks of gestation).","7 Days",{"count":152,"type":22},740,[154],"PHASE3","The study will compare the transmissible levels of poliovirus type-2 detected in stool samples collected at the time of the nOPV2 challenge and subsequent timepoints in 3 groups of newborns receiving an nOPV2 dose at birth and primed with 3 doses of IPV (6 - 10 - 14 weeks of age).",[28],[112,158,159],"nOPV2","immunity","NOT_YET_RECRUITING","2025-07-21",{"date":163,"type":39},"2025-07-24",{"date":165,"type":22},"2025-12-08",{"date":167,"type":22},"2026-09-21",{"name":169,"class":46},"Fidec Corporation",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":16,"sex":17,"minAge":103,"maxAge":177,"enrollmentInfo":178,"targetDuration":4,"studyType":23,"phases":179,"briefSummary":181,"conditions":182,"keywords":183,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":142},"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":58,"type":22},[180,25],"PHASE1","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.",[28],[111,184,185,186,187,188],"Trivalent","Immunogenicity","Safety","12-18 months toddlers","2 months infants","2025-07-02",{"date":191,"type":39},"2025-07-04",{"date":193,"type":39},"2024-12-19",{"date":195,"type":22},"2026-12",{"name":197,"class":72},"CanSino Biologics Inc.",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":16,"sex":17,"minAge":103,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":23,"phases":208,"briefSummary":209,"conditions":210,"keywords":216,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":142},"100588906","phase-2-a-phase-iiiii-study-to-evaluate-the-immunogenicity-safety-and-lot-to-lot-consistency-of-lbvd-a-fully-liquid-hexavalent-diphtheria-tetanus-whole-cell-pertussis-hepatitis-b-poliovirus-haemophilus-influenzae-type-b-conjugate-dtwp-hepb-ipv-hib-vaccine-in-healthy-infants-as-primary-series-100588906","NCT06947499","A Phase II\u002FIII Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series","A Prospective, Multi-national, Multi-center, Open-label, Randomized, Active Controlled, Parallel Group, Operationally Seamless Phase II\u002FIII Clinical Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus (Inactivated)-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, Compared to Co-administration of DTwP-HepB-Hib Vaccine and IPV Vaccine in Healthy Infants at 6-, 10-, and 14-week of Age as Primary Series","Inclusion Criteria:\n\n* healthy infants from 6 weeks to 8 weeks of age (both inclusive)\n* body weight ≥ 3.2 kg\n* born at full term pregnancy (≥ 37 weeks)\n* signed informed consent by parent(s) or legally acceptable representative(s)\n\nExclusion Criteria:\n\n* Known history of Hib infection, HepB, diphtheria, tetanus, pertussis, or poliomyelitis\n* Household contact or intimate exposure with a confirmed case of Hib, HepB, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to study registration\n* Known history of SARS-CoV-2 infection\n* Participant's mother is HepB antigen or HIV positive\n* Fever ≥ 38.0 C\u002F100.4 F within 3 days prior to enrollment\n* Vaccination history of non-study vaccines within 30 days prior to enrollment except for pneumococcal conjugate, rotavirus, HepB and Bacillus Calmette Guerin (BCG)\n* Previous use of any diphtheria, tetanus, pertussis-based combination vaccine(s), Hib conjugate, poliovirus, or combination\n* Received immunosuppressive agents or other immune-modifying drugs\n* Previous use of blood or blood-derived products\n* Any history of allergy (hypersensitivity) to any of the vaccine components\n* Participation in another interventional clinical trial within 4 weeks of expected first vaccination","8 Weeks",{"count":207,"type":22},1186,[25,154],"The purpose of this study is to evaluate immunogenicity, safety and lot-to-lot consistency of LBVD in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants",[211,212,213,214,28,215],"Diphtheria","Tetanus","Pertussis","Hepatitis B","Haemophilus Influenzae Type b",[217],"vaccination","2025-06-30",{"date":220,"type":39},"2025-07-03",{"date":222,"type":39},"2025-05-30",{"date":224,"type":22},"2027-04",{"name":226,"class":72},"LG Chem",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":16,"sex":17,"minAge":129,"maxAge":234,"enrollmentInfo":235,"targetDuration":4,"studyType":23,"phases":237,"briefSummary":238,"conditions":239,"keywords":240,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":252},"100526662","phase-1-study-of-trivalent-and-bivalent-types-1--2-novel-oral-poliomyelitis-vaccines-100526662","NCT06137664","Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines","A Phase 1\u002F2, Randomized, Observer-Blind, Active-Controlled, Age De-escalation, Dose Combination Ranging Study to Assess the Safety and Immunogenicity of Co-administered Novel Live Attenuated Trivalent Oral Poliomyelitis Vaccine in Healthy Adults, Young Children, and Neonates and Co-administered Novel Live Attenuated Monovalent Oral Poliomyelitis Vaccines 1 and 2 in Neonates in Bangladesh","Inclusion Criteria\n\nInclusion Criteria for all participants:\n\n1. Healthy, as defined by the absence of any clinically significant medical condition or congenital anomaly as determined by medical history, physical examination, and clinical assessment of the investigator.\n2. Participant or parent of the participant is willing and able to provide written informed consent prior to performance of any study-specific procedure.\n3. Resides and plans to remain in study area and participants and parent, when applicable, understands and is able and willing to adhere to all study visits and procedures (as evidenced by a signed informed consent form \\[ICF\\] and assessment by the investigator).\n\n   Inclusion Criteria for Cohort 1 participants only:\n4. Males or females, from 18 to 45 years of age (inclusive) at the time of enrollment.\n5. If female and of childbearing potential\\*, not breastfeeding and not pregnant (based on a negative urine pregnancy test at screening and a negative urine pregnancy test during the 24 hours prior to any study vaccination \\[if screening occurs within 24 hours prior to vaccination, a single negative pregnancy test is acceptable\\]), agreeing to not become pregnant through other means (e.g., artificial insemination and IVF) and have repeated pregnancy tests prior to any study vaccination, and having practiced adequate contraception\\*\\* for 30 days prior to first study vaccination and willing to continue using adequate contraception consistently for at least 90 days after the last study vaccination.\n6. Born and raised in Bangladesh in 1990 or later; if born before 1990 or not born and raised in Bangladesh, has documentation of a complete poliomyelitis immunization series containing OPV or IPV.\n\n   Inclusion Criteria for Cohort 2 participants only:\n7. Male or female child from 1 to less than 5 years of age at the time of enrollment (from the first birthday up to the day prior to the fifth birthday).\n8. Based on documentation, previously received a 3 or 4 dose primary poliomyelitis immunization series containing bOPV ± IPV, with last dose received more than 3 months prior to initial study vaccination.\n\n   Inclusion Criteria for Cohort 3 participants only:\n9. Male or female newborn neonate (day of birth+ 3-day window), at the time of initial study vaccination.\n10. Prior to study vaccination has received no doses of IPV or OPV or rotavirus vaccine, based upon documentation or parental history.\n11. Agreement to receive polio EPI vaccines under a modified schedule.\n\nExclusion Criteria\n\nExclusion Criteria for all participants (unless otherwise specified):\n\n1. Presence of anyone under 10 years of age in the participant's household (living in the same house or apartment unit) who does not have complete \"age appropriate\" vaccination status with respect to poliovirus vaccines based on the vaccination records at the time of study vaccine administration. For household members younger than 10 years of age-appropriate vaccination is a complete series of at least three doses of OPV.\n2. A known allergy, hypersensitivity, or intolerance to any components of the study vaccines, including all macrolide and aminoglycoside antibiotics (e.g., erythromycin and kanamycin).\n3. Any self-reported known or suspected immunosuppressive or immunodeficiency condition (including HIV infection) in the participant or household member (living under the same roof\u002Fin the same building rather than in the same compound).\n4. Receipt of any immune-modifying or immunosuppressant drugs within 6 months prior to the first study vaccine dose or planned use during the study.\n5. Any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection.\n6. Moderate or severe (grade ≥ 2) acute illness including vomiting, diarrhea at the time of enrollment\u002Ffirst study vaccination - temporary exclusion.\n7. Presence of fever within the 72 hours of the day of enrollment\u002Ffirst study vaccination (oral temperature ≥38.0˚C for Cohort 1; axillary temperature ≥37.5˚C for Cohorts 2 and 3) or any antipyretic use within past 24 hours - temporary exclusion for Cohorts 1 and 2.\n8. Evidence of a clinically significant major congenital or genetic defect as judged by the investigator.\n9. History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids (\\> 0.5mg\u002Fkg\u002Fday or 20 mg\u002Fday of prednisolone (or equivalent) within 6 months prior to first study vaccine dose. Topical and inhaler steroids are permitted (unless indicative of a significant chronic illness otherwise excluding the young child).\n10. Participation in another investigational product (drug or vaccine, including prior polio vaccine trials) clinical trial within 30 days prior to entry in this study or receipt of any such investigational product other than the study vaccine within 30 days prior to the first administration of study vaccine, or planned participation in another investigational product clinical trial during the study period.\n11. Receipt of transfusion of any blood product or immunoglobulins within 12 months prior to the first administration of study vaccine or planned during the study period.\n12. Participant or parent, when applicable, has any condition that in the opinion of the investigator would increase the participant's health risks in study participation or would increase the risk of not achieving the study's objectives (e.g., would compromise adherence to protocol requirements or interfere with planned safety and immunogenicity assessments).\n\n    Exclusion Criteria for Cohort 1 participants:\n13. Receipt of polio vaccine within 12 months before the start of the study.\n14. Having Crohn's disease or ulcerative colitis or having had major surgery of the gastrointestinal tract involving significant loss or resection of the bowel.\n15. Will have household direct or close professional contact during the study with pregnant women.\n16. Will have household direct or close professional (e.g., neonatal nurses) contact during the study with children less than 2 years of age or with individuals who are encopretic (i.e., soiling of underwear with stool by children who are past the age of toilet training or other individuals, including adults, with fecal incontinence).\n17. Will have professional handling of food, catering, or food production activities during the study.\n\n    Exclusion Criteria for Cohort 2 participants:\n18. Any participating children attending day care or pre-school during their participation in the study until one month after their last study vaccine administration.\n19. Presence of severe malnutrition \\[weight-for-length\u002Fheight z-score \\\u003C-3SD median (per WHO published child growth standards)\\]-temporary exclusion if marginal and subsequently gains weight.\n\n    Exclusion Criteria for Cohort 3 participants:\n20. Low birth weight (LBW) in newborn participants which is defined as a birth weight of less than 2500 g (up to and including 2499 g) at the time of birth or by the time of enrollment\n21. Premature birth (less than 37 weeks gestation).\n22. From multiple birth (due to increased risk of OPV transmissions between siblings).","45 Years",{"count":236,"type":22},2400,[180,25],"The main objectives of this study are to :\n\n* evaluate the safety and tolerability of trivalent novel oral poliovirus vaccines (tnOPV) in healthy adults, young children, and neonates, relative to those receiving control vaccines;\n* evaluate the safety and tolerability of combined novel oral poliovirus vaccine type 1 (nOPV1) + novel oral poliovirus vaccine type 2 (nOPV2) in neonates, relative to those receiving the bivalent (types 1 and 3) oral poliovirus vaccine (bOPV) control.\n* compare type-specific cumulative seroconversion rates of poliovirus neutralizing antibody (NAb) titers, among all tnOPV dose combinations, following 4 vaccinations in healthy neonates;\n* evaluate the type-specific cumulative seroconversion rate of poliovirus NAb titers among healthy neonates following 4 doses of combined nOPV1+nOPV2.",[28],[241,242,243],"poliovirus vaccine","Trivalent oral poliovirus vaccine","Novel oral poliovirus vaccine","2025-05-28",{"date":246,"type":39},"2025-06-03",{"date":248,"type":39},"2024-11-20",{"date":250,"type":22},"2027-12-15",{"name":45,"class":46},2,{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":16,"sex":17,"minAge":260,"maxAge":261,"enrollmentInfo":262,"targetDuration":4,"studyType":23,"phases":264,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"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":263,"type":22},336,[25],"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.",[211,212,213,214,28,267],"Haemophilus Influenzae Type B Infection","2024-09-26",{"date":270,"type":39},"2024-10-01",{"date":272,"type":22},"2024-10-02",{"date":274,"type":22},"2026-04-30",{"name":226,"class":72}]