[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573617":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":37,"centralContacts":54,"locations":37,"responsibleParty":64,"collaborators":37,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":37,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":37,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":37,"overallStatus":85,"whyStopped":37,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":37},{"fullName":5,"class":6},"International Centre for Diarrhoeal Disease Research, Bangladesh","OTHER",[8,15,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","EXPERIMENTAL","Arm A will receive wP-Penta at 6,10,14 weeks of age and 2 doses of IPV at 14 weeks and 9 months.",[13,14],"Biological: Pentavalent vaccine","Biological: Inactivated poliovirus vaccine (IPV)",{"label":16,"type":10,"description":17,"interventionNames":18},"Arm B","Arm B will receive wP-Hexa at 6,10,14 weeks of age",[19],"Biological: Hexavalent vaccine",{"label":21,"type":10,"description":22,"interventionNames":23},"Arm C","Arm C will receive wP-Hexa at 2,4,6 months of age.",[19],{"label":25,"type":26,"description":27,"interventionNames":28},"Control Arm","ACTIVE_COMPARATOR","Control group will receive EPI schedule of routine immunization: fIPV @ 6, 14 wk, bOPV @ 6, 10, 14 wk , wP-Penta @ 6, 10, 14 wk",[13,29,30],"Biological: Bivalent oral polio vaccine (bOPV)","Biological: Fractional IPV( fIPV)",[32,38,42,46,50],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"BIOLOGICAL","Pentavalent vaccine","Whole-cell pertussis pentavalent vaccine (wP-Penta): Each 0.5 ml dose contains diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen, Haemophilus influenzae type b conjugate",[9,25],null,{"type":33,"name":39,"description":40,"armGroupLabels":41,"otherNames":37},"Hexavalent vaccine","Whole-cell pertussis hexavalent vaccine (wP-Hexa): Each 0.5 ml dose contains diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen, Haemophilus influenzae type b conjugate, and inactivated polioviruses to all three poliovirus types: type 1 , 2 and 3",[16,21],{"type":33,"name":43,"description":44,"armGroupLabels":45,"otherNames":37},"Inactivated poliovirus vaccine (IPV)","one dose of IPV (0.5 mL) contains inactivated polioviruses to all three poliovirus types: type 1, 2 and 3",[9],{"type":33,"name":47,"description":48,"armGroupLabels":49,"otherNames":37},"Bivalent oral polio vaccine (bOPV)","Contain two poliovirus types: type 1 and 3",[25],{"type":33,"name":51,"description":52,"armGroupLabels":53,"otherNames":37},"Fractional IPV( fIPV)","The dose of fIPV is 0.1 mL or 1\u002F5th of a full dose",[25],[55,60],{"name":56,"role":57,"phone":58,"phoneExt":37,"email":59},"Khalequ Zaman, MBBS, MPH, PhD, FRCP Edin","CONTACT","+8801713047100","kzaman@icddrb.org",{"name":61,"role":57,"phone":62,"phoneExt":37,"email":63},"Concepcion F. Estivariz, PhD","Cell phone: (470) 312-5677","cge3@cdc.gov",{"type":65,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","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",false,"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.",true,"ALL","42 Days","48 Days",{"count":77,"type":78},1190,"ESTIMATED","INTERVENTIONAL",[81],"PHASE4","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.",[84],"Polio","NOT_YET_RECRUITING","2024-12-21",{"date":88,"type":89},"2024-12-27","ACTUAL",{"date":91,"type":78},"2025-01-28",{"date":93,"type":78},"2027-12-30",{"name":5,"class":6}]