[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"PATH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":171},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,75,102,122,145],{"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100583669","phase-2-infant-malaria-vaccine-schedule-optimization-100583669",false,"NCT06879327","Infant Malaria Vaccine Schedule Optimization","A Phase 2b Multicenter Randomized, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of R21\u002FMatrix-M Malaria Vaccine in African Infants With Different Immunization Schedules","Inclusion Criteria:\n\n* Signed informed consent or thumb-printed and witnessed informed consent obtained from the parent\u002Flegal guardian of the infant.\n* Infants must have been born full-term (at ≥37 weeks of gestation) and \\> 2500 grams at birth.\n* Immunization schedule Cohorts 1, 2, and 3: Male and female infants 42-49 days (inclusive) of age at time of enrollment.\n* Prior to group randomization, for infants in Cohort 1 randomization to receive vaccine dose 1 (Groups 1 and 2 of R21\u002FMM or placebo, respectively) will occur at 42-49 days of age. Infants in Cohorts 2 and 3 will not be randomized to R21\u002FMM or placebo; placebo will no longer be given. Rather infants in these cohorts will receive open-label R21\u002FMM according to the immunization schedule category to which they have been randomized. Infants in Cohort 2, will receive their open-label R21\u002FMM vaccine dose 1 (Group 3) at 2 months (56-63 days of age). Infants in Cohort 3, will receive their open-label R21\u002FMM vaccine dose 1 (Group 5) at 3 months (84-91 days of age).\n* The participant's parent\u002Fguardian must be willing to avoid travel, particularly in the 28 days after each study vaccination, must confirm willingness to contact the study team in the event of unexpected\u002Funavoidable travel and, for the safety cohort, must confirm availability for the home visits to be conducted by a field worker or nurse to collect solicited AEs over the 7 days (day of vaccination and 6 subsequent days) following each study vaccine.\n* The participant's parent\u002Fguardian must confirm willingness to bring their child to the study clinic \u002F local health care clinic, and capacity to contact the study team in the event the subject has any illnesses or other health concerns during the study.\n* Participants who the investigator believes that their parent\u002Fguardian can and will comply with the requirements of the protocol (e.g. return for follow-up visits) may be enrolled in the study.\n\nExclusion Criteria:\n\n• Acute disease at the time of enrolment (acute disease is defined as the presence of a moderate or severe illness with or without fever). This does not include minor illnesses such as diarrhea, mild upper respiratory infection, without low-grade febrile illness, i.e. axillary temperature \\\u003C 37.5°C or tympanic temperature \\\u003C 38°C.\n\n(Note: In case of acute disease, participants may be re-assessed by a study physician for resolution of the condition and enrolled if eligible and still within the visit window).\n\n* Clinically significant pulmonary, cardiovascular, gastrointestinal, endocrine, neurological, skin, hepatic or renal functional abnormality, as determined by medical history, physical examination or laboratory tests which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial.\n* At time of enrollment, any infant who has received any dose of the hexavalent\u002Fpentavalent vaccines, pneumococcal vaccine, rotavirus vaccine, IPV or has received more than one dose of oral polio virus or more than one dose of hepatitis B vaccine.\n* Weight-for-length\u002Fheight Z score of less than -3 or other clinical signs of malnutrition.\n* Infant with major congenital defects.\n* The infant has anaemia associated with clinical signs of symptoms of decompensation, or a haemoglobin of ≤ 5.0 g\u002FdL.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.\n* Any confirmed or suspected immunosuppressive or immunodeficient state (including HIV or asplenia) or known maternal HIV infection (no HIV testing will be routinely done by the study team).\n* Administration of immunoglobulins and\u002For any blood products\u002Fblood transfusion from birth to time of planned administration of the vaccine candidate.\n* Previous vaccination of participant or biological mother with a malaria vaccine.\n* Participation in another research study involving receipt of an investigational product or planned use during the study period.\n* Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.",true,"ALL","42 Days","49 Days",{"count":21,"type":22},964,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The aim of this study is to identify an optimal infant vaccine schedule for a malaria vaccine which is better aligned with the timing of other vaccine interventions.",[28],"Malaria Vaccines",[30,31],"Plasmodium falciparum","R21\u002FMatrix-M Malaria Vaccine","RECRUITING","2026-05-13",{"date":35,"type":36},"2026-05-15","ACTUAL",{"date":38,"type":36},"2025-05-30",{"date":40,"type":22},"2027-09-27",{"name":42,"class":43},"PATH","OTHER",2,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":16,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100489541","phase-2-study-of-a-novel-type-3-oral-poliomyelitis-vaccine-in-panama-100489541","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).","1 Day","4 Years",{"count":55,"type":22},1532,[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 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).",[59],"Poliomyelitis",[61,62,63,64,65],"Vaccine tolerability","Vaccine safety","Vaccine reactogenicity","Vaccine viral shedding","Vaccine immunogenicity","2026-05-06",{"date":68,"type":36},"2026-05-11",{"date":70,"type":36},"2023-12-05",{"date":72,"type":22},"2027-03-20",{"name":42,"class":43},3,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":16,"sex":17,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":74},"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":86,"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.",[59],[91,92,59,93],"Vaccine","Polio","novel oral polio vaccine","2026-01-07",{"date":96,"type":36},"2026-01-09",{"date":98,"type":36},"2025-11-11",{"date":100,"type":22},"2026-12-28",{"name":42,"class":43},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":16,"sex":17,"minAge":109,"maxAge":53,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":120,"locationsCount":121},"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":111,"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).",[59],[61,62,63,64,65],{"date":96,"type":36},{"date":118,"type":36},"2023-03-27",{"date":35,"type":22},{"name":42,"class":43},1,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":17,"minAge":129,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":4},"100526067","assessing-the-acceptability-feasibility-effectiveness-and-cost-effectiveness-of-ladb-100526067","NCT06129916","Assessing the Acceptability, Feasibility, Effectiveness and Cost-effectiveness of LADB","Assessing the Acceptability, Feasibility, Effectiveness and Cost-effectiveness of Long-acting Depot Buprenorphine (LADB) for the Treatment of Opioid Dependence in Low- and Middle-income Countries (LMIC): a Multicentre International Study","Inclusion Criteria:\n\n* Are 18 years old or older.\n* Are verified (by certified clinician) opioid dependents according to the International Classification of Diseases 11th Revision.\n* Are not pregnant (verified by screening).\n* Are eligible to receive OAMT at a participating site.\n* Consent to attend the clinic and adhere to clinical protocols\n* Have the capacity to consent to participating in research.\n* Provide written informed consent.\n\nExclusion Criteria:\n\n* Have a history or presence of an allergic or adverse response (including rash or anaphylaxis) to BUP or the Atrigel® delivery system (a registered trademark of Tolmar Therapeutics Inc.) if Sublocade is chosen.\n* Have any contraindication to BUP or methadone.\n* Show signs of clinically significant medical conditions which would compromise compliance with the protocol and\u002For client safety in line with clinical guidelines for the administration of injectable BUP for OAMT.\n* Are currently taking oral or depot naltrexone therapy or are enrolled in any form of naltrexone therapy within 30 or 90 days prior to study screening, respectively.\n* Are in thepost partum period (defined as 6 weeks) or confirmed as pregnant.\n* Have an inability or unwillingness to provide informed consent or abide by the requirements of the study.","18 Years",{"count":131,"type":22},760,"OBSERVATIONAL","The goal of the proposed study is to generate evidence on the acceptability, feasibility, effectiveness, and cost-effectiveness of introducing long-acting depot buprenorphine (LADB) as an additional option for the treatment of opioid dependence in low- and middle-income countries (LMIC) among people who inject drugs (PWID) with opioid dependence. The study results will be used to inform global and local policies and guidelines to introduce LADB as a treatment option and to advocate for access to a sustainable supply of LADB in LMIC.",[135],"Opioid Dependence","NOT_YET_RECRUITING","2025-10-01",{"date":139,"type":36},"2025-10-07",{"date":141,"type":22},"2025-11-01",{"date":143,"type":22},"2027-06-30",{"name":42,"class":43},{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":16,"sex":17,"minAge":109,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":23,"phases":155,"briefSummary":157,"conditions":158,"keywords":159,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":44},"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":154,"type":22},2400,[156,25],"PHASE1","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.",[59],[160,161,162],"poliovirus vaccine","Trivalent oral poliovirus vaccine","Novel oral poliovirus vaccine","2025-05-28",{"date":165,"type":36},"2025-06-03",{"date":167,"type":36},"2024-11-20",{"date":169,"type":22},"2027-12-15",{"name":42,"class":43},""]