[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"polio\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:polio":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,70,92,123],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100618994","the-five-year-antibody-persistence-after-immunization-with-ipv-mmr-and-hepa-l-vaccines-100618994",false,"NCT07338851","the Five-year Antibody Persistence After Immunization With IPV, MMR and HepA-L Vaccines","Evaluation on the Persistence of Sabin Strain Inactivated Poliovirus Vaccine (Vero Cell), Combined Live Attenuated Measles, Mumps and Rubella Vaccine and Freeze-dried Live Attenuated Hepatitis A Vaccine in Chinese Children: Up to 5 Years of Follow-up","Inclusion Criteria:\n\n* Participants in the NCT04638985 or NCT04636827, and who have completed the vaccination of designated batch numbers of sIPV, MMR or HepA-L vaccines;\n* The time window from the day of enrollment to the date when the participants received the fourth dose of sIPV vaccine, the second dose of MMR vaccine, or the first dose of HepA-L vaccine was 60 to 66 months.\n* The informed consent form shall be signed by the participant or his\u002Fher legal guardian and dated.\n\nExclusion Criteria:\n\n* None.",true,"ALL",{"count":19,"type":20},600,"ESTIMATED","OBSERVATIONAL","This study evaluated the antibody persistence of Chinese children five years after they received four doses of sIPV, two doses of MMR vaccine and one dose of HepA-L vaccine.",[24,25,26,27,28],"Polio","Measles","Rubella","Mumps","Hepatitis A","NOT_YET_RECRUITING","2026-01-04",{"date":32,"type":33},"2026-01-14","ACTUAL",{"date":35,"type":20},"2026-01-30",{"date":37,"type":20},"2027-12-31",{"name":39,"class":40},"China National Biotec Group Company Limited","INDUSTRY",6,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":49,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100586798","phase-4-study-of-concomitant-administration-of-the-sipv-and-dtap-or-mmr-100586798","NCT06920069","Study of Concomitant Administration of the sIPV and DTaP or MMR","Phase IV Study of Evaluating Immunogenicity and Safety of Concomitant Administration of Sabin-strain-based Inactivated Poliovirus Vaccine (Vero Cells) and Adsorbed Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine or Measles, Mumps and Rubella Combined Live-attenuated Vaccine","Inclusion Criteria:\n\n* Age Requirement: Infants aged 2 months at the time of enrollment\n* Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.\n* Informed Consent: Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, and sign the informed consent form.\n* Adherence: Legal guardians or appointed representatives of volunteers must be able to comply with the requirements in the study as well as complete relevant visits on time.\n* Birth Condition: Full-term at birth (gestational age ≥ 37 weeks and \\\u003C 42 weeks) and birth weight ≥ 2500g\n\nExclusion Criteria:\n\n* Vaccination History: received vaccines containing diphtheria-tetanus-pertussis antigens, polio antigens, Hib conjugate vaccine, or 13-valent pneumococcal conjugate vaccine before enrollment.\n* Those who had received blood transfusions or used blood products (except hepatitis B immunoglobulin) before enrollment.\n* Recent Vaccination: Volunteers received any inactivated vaccines or subunit vaccines within 7 days (including the 7th day) prior to vaccination with the investigational vaccine, or any other live attenuated vaccines within 14 days (including the 14th day) prior to vaccination.\n* Acute Illness: Volunteers have experienced acute illnesses (e.g., fever) within 3 days before enrollment, or have used antipyretic analgesics or antihistamines within 3 days.\n* Allergic History: Volunteers who are allergic to any component of sIPV, bOPV, DTaP, or MMR, or who are allergic to kanamycin sulfate, kanamycin, or gentamicin sulfate, or those with an allergic constitution.\n* Birth Condition: Severe neonatal diseases caused by abnormal delivery and other reasons, such as birth trauma, neonatal asphyxia, respiratory distress syndrome, neonatal intracranial hemorrhage, etc., or patients with clinically confirmed severe hyperbilirubinemia.\n* Neurological and Mental Health: Volunteers with encephalopathy, convulsions, epilepsy, or other progressive neurological disorders, or those whose families have a history of genetic predisposition to convulsions or epilepsy, or a history of genetic predisposition to mental illness.\n* History of Related Illness: Volunteers who have a history of poliomyelitis, pertussis, diphtheria, tetanus, measles, rubella, or mumps.\n* Immune Therapy: Volunteers with immunodeficiency, weakened immune function, or those who have received immunosuppressive therapy (such as long-term systemic glucocorticoid treatment, but excluding local medications like inhalants or nasal sprays).\n* Other Diseases: Volunteers with severe diseases, encompassing those in the cardiovascular system, blood and lymphatic systems, immune system, kidneys, liver, gastrointestinal tract, respiratory system, metabolism, and bones, etc.\n* Participation in Other Clinical Studies: Volunteers are currently or have plans to participate in other clinical studies before enrollment.\n* Investigator's Discretion: The final exclusion criterion is the investigator's discretion to determine whether a volunteer is suitable for participation in the study.","2 Months",{"count":51,"type":20},2640,"INTERVENTIONAL",[54],"PHASE4","This study is a randomized, open-labeled phase IV clinical trial to evaluate the immunogenicity and safety of concomitant administration of sIPV and DTaP or MMR in infants aged 2 months. Primary immunogenicity endpoints in all groups include the seroconversion rate of type I, II, and III anti-poliovirus neutralizing antibodies, anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 30 days after basic immunization. Secondary immunogenicity endpoints include the seropositive rates, seroconversion rates, geometric mean titer\u002Fconcentration (GMT\u002FGMC), geometric mean fold increase (GMFI) of type I, II, and III anti-poliovirus neutralizing antibodies, anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies, and anti-measles, anti-mumps, and anti-rubella antibodies 30 days after full immunization. The secondary safety endpoints are the incidence of adverse events (AEs) within 30 minutes after each injection, the incidence of solicited local and systematic AEs in the period of solicitation after each injection, the incidence of unsolicited AEs in 30 days after each injection, the incidence of AEs in 30 days after each injection, and the incidence of serious adverse events in 6 months after administrations.",[24,57,58],"Diphteria, Tetanus and Pertussis","MMR Vaccine","2025-04-14",{"date":61,"type":33},"2025-04-17",{"date":63,"type":20},"2025-05-15",{"date":65,"type":20},"2031-06-15",{"name":67,"class":68},"Institute of Medical Biology, Chinese Academy of Medical Sciences","OTHER",9,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":16,"sex":17,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":52,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":4},"100573617","phase-4-immunogenicity-of-different-primary-immunization-schedules-with-inactivated-poliovirus-vaccine-ipv-plus-pentavalent-vaccine-dtwp-hbv-hib-or-with-hexavalent-vaccine-dtwp-hbv-hib-ipv-100573617","NCT06748612","Immunogenicity of Different Primary Immunization Schedules with Inactivated Poliovirus Vaccine (IPV) Plus Pentavalent Vaccine (DTwP-HBV-Hib) or with Hexavalent Vaccine (DTwP-HBV-Hib-IPV)","A. Assessment of seroprotection and safety of wP-Hexa with primary immunization schedules.\n\nInclusion Criteria:\n\n1. Healthy infants 6 weeks of age (range: 42-48 days).\n2. Parents that consent for participation in the full length of the study.\n3. Parents that can understand and comply with planned study procedures.\n\nExclusion Criteria:\n\n1. Parents and infants are unable to participate in the full length of the study (e.g., plan to move away from the study area during the study period).\n2. A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.\n3. A diagnosis or suspicion of bleeding disorder that would contraindicate administration of IPV, wP Penta or wP-Hexa, or collection of blood by venepuncture.\n4. Acute diarrhoea, infection, or illness at the time of first study vaccination that would require infant's admission to a hospital.\n5. Acute vomiting and intolerance to liquids within 24 hours before the first study vaccination.\n6. Any encephalopathy of unknown origin occurring within 7 days following previous vaccination with any pertussis containing vaccine.\n7. Uncontrolled neurologic disorder or uncontrolled epilepsy (Pertussis vaccine should not be administered to individuals with these conditions until the treatment regimen has been established and the condition has stabilized).\n8. Evidence of a chronic medical condition identified by a study medical officer during physical exam.\n9. Receipt of any polio vaccine (OPV or IPV) before enrolment based upon documentation or parental recall.\n10. Known allergy\u002Fsensitivity or reaction to polio, pertussis, tetanus, diphtheria, hepatitis B, Hib vaccines or its contents.\n11. Infants from multiple births. This exclusion is done because the non-participant infant will likely receive OPV through routine immunization and may transmit vaccine poliovirus to the enrolled infant.\n12. Infants from premature births (\\\u003C37 weeks of gestation).\n\nB. Mucosal immunity against poliovirus sub-study :\n\nInclusion criteria\n\n* Participants:\n\n  * Participants in study arms A and B who complete study procedures up to 18 months and whose parents do not request discontinuation\n* Controls:\n\n  * Children aged 18 months who have received polio vaccination through routine immunization services verified by immunization card (bOPV at 6, 10 and 14 weeks; fIPV at 6 and 14 weeks)\n\nExclusion criteria\n\n1. Parents and infants are unable to participate in the full length of the study (e.g., plan to move away from the study area during the study period).\n2. A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.\n3. A diagnosis or suspicion of bleeding disorder that would contraindicate administration of bOPV or collection of blood by venepuncture.\n4. Acute diarrhoea, infection, or illness at the time of enrolment (18 months of age) that would require infant's admission to a hospital.\n5. Febrile disease that contraindicates administration of pentavalent vaccine (even if hospitalization is not required).\n6. Acute vomiting and intolerance to liquids within 24 hours before the enrolment visit (18 months of age).\n7. Known allergy\u002Fsensitivity or reaction to oral polio vaccines or its contents.\n8. Received any polio vaccines outside of the routine immunization schedule.\n9. Household members have received OPV within 1-2 months prior to enrolment.","42 Days","48 Days",{"count":79,"type":20},1190,[54],"The goal of this study is to provide information on immunogenicity at short and medium term for hexavalent with different schedules, which will be useful for the global polio program and countries, including Bangladesh.\n\nPrimary objectives are\n\n1. To compare the proportion of participants who seroconvert to all poliovirus serotypes four weeks after a primary immunization series.\n2. To compare the proportion of participants seropositive against all poliovirus serotypes at 18 months of age.\n\nThis is an open-label randomized clinical trial. Participants will be enrolled and randomized at 6 weeks of age to one of three arms. Target enrolment is 330 infants per arm and 200 controls; 990 in the main study and \\~ 800 in the sub-study.\n\nA total of 4-5 blood samples will be collected from each infant before and after the primary vaccination series, and at 18 months of age, to assess systemic immune response to different antigens.\n\nOutcome measures\u002Fvariables:\n\nNeutralizing antibody titers in serum will be quantified for poliovirus types 1, 2, and 3 using a microneutralization test; for diphtheria toxoid, tetanus toxoid, and pertussis toxin using a Multiplex bead assay; and for antibodies to hepatitis B surface antigen (anti-HBs) using serologic assay. The presence of poliovirus types 1 and 3 in oropharyngeal swabs and stools following the bOPV challenge will be tested using a real-time reverse transcription PCR (rRT-PCR) assay.",[24],"2024-12-21",{"date":85,"type":33},"2024-12-27",{"date":87,"type":20},"2025-01-28",{"date":89,"type":20},"2027-12-30",{"name":91,"class":68},"International Centre for Diarrhoeal Disease Research, Bangladesh",{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":16,"sex":17,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":52,"phases":103,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":122},"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":102,"type":20},785,[104],"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.",[107,108,109,110,24],"Pertussis","Diphtheria","Tetanus","Haemophilus Influenzae Type B Infection","RECRUITING","2024-09-18",{"date":114,"type":33},"2024-09-20",{"date":116,"type":33},"2024-09-05",{"date":118,"type":20},"2026-02",{"name":120,"class":121},"Jiangsu Province Centers for Disease Control and Prevention","NETWORK",1,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":16,"sex":17,"minAge":130,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":52,"phases":133,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},"100551473","phase-4-phase-iv-study-of-concomitant-administration-of-the-sipv-and-hepa-100551473","NCT06460545","Phase IV Study of Concomitant Administration of the sIPV and HepA","Phase IV Study of Evaluating Immunogenicity and Safety of Concomitant Administration of Sabin-strain-based Inactivated Poliovirus Vaccine (Vero Cells) and Freeze-dried Live-attenuated Hepatitis A Vaccine or Inactivated Hepatitis A Vaccine","Inclusion Criteria:\n\n* Age Requirement: Children aged 4 months at the time of enrollment\n* Vaccination Requirement: volunteers have already taken administration 2 doses of sabin-strain-based inactivated poliovirus vaccine (produced by IMBCAMS), and have not yet been injected with the third dose containing poliovirus antigen.\n* Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.\n* Informed Consent: Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, and sign the informed consent form.\n* Adherence: Legal guardians or appointed representatives of volunteers must be able to comply with the requirements in the study as well as complete relevant visits on time.\n* Birth condition: Full-term birth (37\\~42 gestational weeks) and normal birth weight (no less than 2500g).\n* Temperature Requirement: Axillary body temperature prior to vaccination is less than 37.3°C.\n\nExclusion Criteria:\n\n* Health Requirement: Volunteers cannot meet health requirements through physical examinations.\n* History of Related Illness: Volunteers have a history of developing Hepatitis A, poliomyelitis, or immunodeficiency.\n* Birth Condition: Volunteers have a history of abnormal labor stage, asphyxia, nervous system damage, or clinically confirmed pathologic jaundice。\n* Allergic History: Volunteers have a history of allergies to any component of the investigational vaccine (e.g., aluminum hydroxide), any history of vaccine allergies, suspected allergies, or any other severe adverse reactions.\n* Vaccine History: Volunteers received any inactivated vaccines or subunit vaccines within 7 days (including the 7th day) prior to vaccination with the investigational vaccine, or any other live attenuated vaccines within 14 days (including the 14th day) prior to vaccination.\n* Acute Illness: Volunteers have experienced acute illnesses (e.g., fever) within 3 days prior to vaccination with the investigational vaccine.\n* Neurological and Mental Health: Volunteers have a history of seizures, convulsions, cerebral palsy, epilepsy, mental illness, or a family history of such conditions.\n* Health Conditions: Volunteers have known congenital abnormalities, developmental disorders, genetic defects, or severe malnutrition, among other conditions.\n* Coagulation Abnormalities: Volunteers have a history of coagulation disorders (e.g., coagulation factor deficiency, coagulation disorders).\n* Infectious Diseases: Volunteers have infectious diseases that may affect the study, such as human immunodeficiency virus (HIV) infection, hepatitis, and tuberculosis.\n* Special Condition: Volunteers who could not tolerate venipuncture, or had a history of needle and blood sickness.\n* Organ Removal History: Volunteers have a history of organ removal (e.g., thyroid, pancreas, liver, spleen).\n* History of Blood Products: Volunteers have a history of loss of blood, blood transfusion, the use of adjuvant therapies, or immunoglobulin within 3 months prior to vaccination.\n* Immune Therapy: Volunteers have received immune-enhancing or immune-suppressing therapy within the last 3 months (continuous oral or intravenous administration for more than 14 days) prior to vaccination.\n* Participation in Other Clinical Studies: Volunteers are currently or have plans to participate in other clinical studies before enrollment.\n* Investigator's Discretion: The final exclusion criterion is the investigator's discretion to determine whether a volunteer is suitable for participation in the study.","4 Months",{"count":132,"type":20},2000,[54],"This study is a randomized, open-labeled phase IV clinical trial to evaluate the immunogenicity and safety of concomitant administration of sIPV and HepA-L or HepA-I in children aged 18 months. The primary immunogenicity endpoints in all groups are the seroconversion rates of type I, II, and III anti-poliovirus neutralizing antibodies and the seroconversion rate of anti-hepatitis A virus antibodies 30 days after the final administration. The secondary immunogenicity endpoints are (1) the GMT\u002FGMC of type I, II, and III anti-poliovirus neutralizing antibodies as well as the anti-hepatitis A virus antibodies 30 days after the final administration; (2) the seropositive rates of the anti-hepatitis A virus antibodies 30 days after the final administration; (3) the GMFI of type I, II, and III anti-poliovirus neutralizing antibodies as well as the anti-hepatitis A virus antibodies 30 days after the final administration. The secondary safety endpoints are the incidence of adverse events (AEs) within 30 minutes after each injection, the incidence of solicited local and systematic AEs in the period of solicitation after each injection, the incidence of unsolicited AEs in 30 days after each injection, the incidence of AEs in 30 days after each injection, and the incidence of serious adverse events in 6 months after administrations.",[24,28],"2024-06-11",{"date":138,"type":33},"2024-06-14",{"date":140,"type":20},"2024-06-15",{"date":142,"type":20},"2027-12-15",{"name":67,"class":68},3]