[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"International Vaccine Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":320},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,44,77,106,133,165,193,219,245,268,293],{"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":27,"conditions":28,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100644085","phase-1-safety-and-immunogenicity-study-of-ip-qsv-vaccine-in-healthy-adultsadolescents-children-and-infants-100644085",false,"NCT07666750","Safety and Immunogenicity Study of IP-QSV Vaccine in Healthy Adults\u002FAdolescents, Children and Infants","A Phase 1\u002F2a, Randomized, Observer-blind, Age-descending, Dose Finding Study to Evaluate the Safety and Immunogenicity of Institut Pasteur Quadrivalent Shigella Vaccine (IP-QSV) for Intramuscular Administration in Healthy Adults\u002FAdolescents, Children and Infants","Inclusion Criteria:\n\n* Individuals aged 18-45 years in Group A, 2-5 years in Groups B and C, 6-8 months in Groups D, E and G , and 9-11 months in Group F\n* Participants\u002F Participants' Legally Acceptable representative (LAR) willing to provide written informed consent to participate in the study voluntarily\n* Participants who can comply with the study requirements\n* Individuals in good health as determined by the outcome of medical history, physical examination, and the clinical judgment of the investigator\n\nExclusion Criteria:\n\n* Known history or allergy to investigational vaccine components or other medications, or any other allergies deemed by the investigator to increase the risk of an adverse event if they were to participate in the trial\n* Individuals with major congenital abnormalities, developmental disorders, genetic defects, or severe malnutrition, among other conditions which in the opinion of investigator may affect the participant's participation in the study\n* Known history of immune function disorders including immunodeficiency diseases (known HIV infection¥ or other immune function disorders) which in the opinion of investigator may affect the participant's participation in the study or interfere with the assessment of the study objectives\n* Use of systemic steroids within past 6 months (\\>10 mg\u002Fday prednisone equivalent for periods exceeding 2 consecutive weeks), or receive chemotherapy, radiation therapy or other immunosuppressive drugs within the past 6 months\n* Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the study objectives\n* Individuals with behavioral or cognitive impairment or psychiatric disease or neural disorders that, in the opinion of the investigator, could interfere with the participant's ability to participate in the trial\n* Individuals with splenectomy\n* Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time resulting in contraindication for IM injections\u002Fblood extractions\n* Receipt of blood, blood-derived products, or immunoglobulin products in the past 3 months\n* Individuals who have received other vaccines from 4 weeks prior to the first dose of investigational product administration or planned to receive any vaccine within 4 weeks post any dose of the investigational product\n* Individuals with active or known previous culture-proven Shigella infection\n* Individuals who have household contact with\u002Fand \u002For intimate exposure to an individual with laboratory confirmed Shigella infection\n* Previous participation in any study in which a Shigella-vaccine candidate was administered\n* Individuals with a history of severe diarrhea in the last 6 months requiring care at a medical facility lasting 24 hours or more\n* Individuals with a history of clinically significant gastrointestinal disorders or with any history of frequent diarrhea, nausea or emesis, within the last 6 months\n* Individuals aged below 5 years with Weight for Height Z score and\u002For Height for Age Z score of less than -3\n* Any female participant who is lactating or pregnant#\n* Females of childbearing potential who do not agree to use an effective birth control method\\* for at least 4 weeks before the screening and up to 12 weeks after the investigational product administration\n* Individuals enrolled in another clinical trial within 6 months prior to enrollment, concomitantly enrolled or scheduled to be enrolled in another trial during study period\n* Individuals who are research staff involved with the clinical trial or household members of research staff\n* As per Investigator's medical judgement, an individual could be excluded from the study despite meeting all inclusion\u002Fexclusion criteria mentioned above\n* Special Conditions for Children Aged 24 Months and Below: For such children, additional exclusion criteria include difficult birth, resuscitation after suffocation, a history of neurological damage, premature birth (delivery before the 37th week of gestation), and low birth weight (less than 2500 grams)\n* Clinically significant abnormal findings in blood tests during the screening",true,"ALL","6 Months","45 Years",{"count":21,"type":22},370,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The goal of this phase 1\u002F2a, randomized, observer-blind, age-descending, dose-finding trial is to evaluate the safety and immunogenicity of a quadrivalent synthetic oligosaccharide-based Shigella vaccine (adjuvanted IP-QSV) in adults, children, and infants in Mali. This first-in-human study is intended to obtain initial data on the safety of the adjuvanted IP-QSV vaccine and its effect on immune responses in a Shigella-endemic region.",[29],"Shigella Infection",[31],"Shigella vaccine","NOT_YET_RECRUITING","2026-06-21",{"date":35,"type":36},"2026-06-24","ACTUAL",{"date":38,"type":22},"2026-07",{"date":40,"type":22},"2028-11",{"name":42,"class":43},"International Vaccine Institute","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"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":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100621979","phase-2-strengthening-hpv-immunization-through-epi-leveraged-delivery-100621979","NCT07377656","Strengthening HPV Immunization Through EPI Leveraged Delivery","A Randomized, Observer-Blind, Placebo-Controlled, Proof-of-Concept Study to Assess the Safety, Tolerability and Immunogenicity of a Bivalent Human Papillomavirus (HPV) Vaccine in 9 and 15 Month Old Infants and Toddlers, 2-5 Year Old Children and an Open Label Single Dose Study in Young Unmarried Females Aged 15-20 Years in Ghana","SHIELD","Inclusion Criteria:\n\n* Healthy male and female individuals aged 9 months, 15 months, 2-5 years and unmarried females aged 15-20 years at the time of vaccination\n* Participants aged 9 months, 15 months and 2-5 years who are up to date with their EPI vaccinations.\n* Residing within the area of the study and planning to stay for the study duration.\n* Participants that are HIV negative at screening (for the 9-15-month-olds a documented negative maternal ANC HIV screening).\n* Unmarried females with a negative pregnancy test at screening practicing\u002Fwilling to practice continuous effective contraception as recommended by the Ghana Health Services guidance in Ghana\n* Able and willing to comply with all study requirements.\n* Willingness to provide written informed consent before any trial procedure. Assent will be required for young female participants aged 15-17 years at vaccination in addition to their parent's\u002FLAR's consent.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnancy, lactation, or intention to become pregnant during the vaccination phase through three months after the study vaccine dose\n* Previous vaccination against HPV (Only for the 15-20-year-old efficacy cohort)\n* Presence of malnutrition (weight-for-length z-score ≤-2SD median, per WHO published child growth standards)\n* Planning to migrate out of the study areas before the end of the study follow-up\n* Any underlying known condition or criteria, including acute or chronic clinically significant abnormality or infection that in the opinion of the investigator might compromise the wellbeing of the participant or interfere with the outcome of the study.\n* Administration of immunoglobulins and\u002F or any blood products within the three months preceding the administration of the study vaccine.\n* Known history of allergy or anaphylaxis to study vaccine components and\u002For excipients or other medications, or any other allergies deemed by the investigator to increase the risk of an adverse reaction.\n* Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent severe infections and chronic use (more than 14 days) of immunosuppressant medication within 3 months prior to recruitment (topical steroids may be allowed).\n* Any other finding that in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial or result in incomplete or poor-quality data.","9 Months","20 Years",{"count":55,"type":22},115,[26],"This is a randomized observer-blind placebo-controlled proof-of-concept study with the aim to assess the safety and tolerability, and the immunogenicity of a bivalent HPV vaccine administered in healthy infants and toddlers (9- and 15-month-olds) comparing them to an immune-bridging population of 15-20-year-old unmarried females in an open label study in Ghana at the Dodowa Health Research Center.",[59],"HPV Vaccine",[61,62,63,50,64,42,65,66],"HPV","Proof of concept","Ghana","IVI","Karolinska Institutet","Dodowa Health Research Center","RECRUITING","2026-05-14",{"date":70,"type":36},"2026-05-18",{"date":72,"type":36},"2026-04-30",{"date":74,"type":22},"2028-12-31",{"name":42,"class":43},1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":16,"sex":17,"minAge":85,"maxAge":19,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":76},"100613761","phase-1-safety-and-immunogenicity-study-of-the-duochol-oral-cholera-vaccine-in-healthy-participants-100613761","NCT07270796","Safety and Immunogenicity Study of the DuoChol Oral Cholera Vaccine in Healthy Participants","A Phase I, Open-label, Randomized, Active-Controlled Trial to Evaluate the Safety and Immunogenicity of the DuoChol Oral Cholera Vaccine in 18 to 45 Years Old Healthy Participants in Sweden","DuoChol","Inclusion Criteria:\n\n1. Healthy male or female participants aged 18 to 45 years, inclusive, at the time of signing the informed consent.\n2. Must have a Swedish (or other nationality) identity card\n3. Must be able to understand the information included in the informed consent form and be willing to provide voluntary informed consent to participate in the study\n4. Must agree to not take any medication affecting gastric acidity (such as proton pump inhibitor, H2 receptor blocker, or antacid) for 7 days prior to and until 24 hours after each vaccination.\n5. Must be able to attend all scheduled study visits and comply with all study procedures.\n6. Must be in good general health and without clinically significant medical history, as determined by the study investigator using clinical judgement after review of medical history, physical examination, and laboratory screening tests (hematology, renal function, and liver function tests).\n7. Female-Specific Criteria:\n\n   1. Not currently pregnant or breastfeeding and not planning to become pregnant for at least 12 weeks after last vaccination.\n   2. Negative urine pregnancy test at the time of vaccination.\n   3. Agree to use at least one acceptable an adequate birth control method for at least 4 weeks prior to receipt of vaccine and for at least 12 weeks after receipt of the vaccine. Adequate birth control is defined as follows: Contraceptive medications delivered orally, intramuscularly, vaginally, or implanted underneath the skin, surgical methods (hysterectomy or bilateral tub l ligation), condoms, diaphragms, intrauterine device, or abstinence\n8. Male-Specific Criteria:\n\n   1. Be willing to use an adequate birth control method during study participation and 12 weeks after the last vaccination.\n   2. For non-vasectomized male participants with female partners of child- bearing potential this includes the use of condoms or abstinence and\u002For their partner's use of contraceptive medications delivered orally, intramuscularly, vaginally, or implanted underneath the skin, surgical methods (hysterectomy or bilateral tubal ligation), diaphragms, or intrauterine device.\n\nExclusion Criteria:\n\n1. Any clinically significant symptom of acute illness (e.g., cough, sore throat), febrile illness (tympanic temperature \\>38°C) within 72 hours prior to the enrollment. A prospective participant should not be included until 72 hours after the condition has completely resolved.\n2. Participant with diarrhea, abdominal pain or vomiting in the past 24 hours or with history of diarrhea lasting for more than 2 weeks in the past 6 months.\n3. Known history of any immunocompromised condition, including immunodeficiency disease, renal function disorder, malignancy, chronic inflammatory disease, etc.\n4. Use of systemic steroids within past 6 months (\\>10 mg\u002Fday prednisone equivalent for period exceeding 2 consecutive weeks), or history of having received chemotherapy, radiation therapy or other immunosuppressive drugs within the past 6 months.\n5. Participant who has ever received previous immunization with cholera vaccine, who has received any vaccine within 4 weeks prior to the first dose of study vaccination, or who plans to receive any other vaccine within 4 weeks following last dose of the investigational product.\n6. Participant concomitantly enrolled or scheduled to be enrolled in another trial.\n7. Participant with previous history of confirmed cholera, salmonella, shigella or ETEC disease.\n8. Known history or allergy to vaccine components, or any other allergies deemed by the investigator to increase risk of an adverse event during trial participation.\n9. Individuals with a known bleeding disorder, or any condition that may be associated with a prolonged bleeding time resulting in contraindication for blood sample collection.\n10. Receipt of blood, blood-derived products, or immunoglobulin products in the past 3 months.\n11. Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant or interfere with the assessment of the study objectives.\n12. Any female participant who is lactating\\*, pregnant, or planning for pregnancy during study period.\n13. Individuals who are involved in DuoChol Clinical trial or family\u002Fhousehold members of research staff.\n14. Any other condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives (e.g., alcohol or drug abuse, neurologic or psychiatric conditions etc.).","18 Years",{"count":87,"type":22},60,[25],"The goal of this phase I, open-label, randomized, active-controlled Trial is to evaluate the safety and immunogenicity of the DuoChol Oral Cholera Vaccine in 18 to 45 years old healthy participants in Sweden. This first-in-human study is intended to obtain initial data on the DuoChol oral cholera vaccine safety and its effect on immune responses in a cholera non-endemic setting to guide future studies in cholera endemic population. The Investigators will evaluate the safety and immunogenicity after each dose vaccination of DuoChol Oral Cholera Vaccine\u002FDukoral®.\n\nThe participants will be randomly assigned to receive 2 vaccinations at 14-day intervals of DuoChol or Dukoral® in a 2:1 ratio. Participants in the DuoChol arm will receive one capsule of DuoChol on days 0 and 14. Participants in the Dukoral® arm will receive the standard dose as indicated in the Dukoral® package insert. The Investigators will follow-up the participants for 4 weeks after the second vaccination.\n\nThe study is funded by Wellcome Trust, grant number : 226726\u002FZ\u002F22\u002FZ.",[91],"Cholera Vaccination Reaction",[93,83,94,95,96,97],"Oral Cholera Vaccine","Phase 1 Trial","V. cholerae O1 Inaba","V. cholerae O1 Ogawa","recombinant cholera toxin B-subunit","2026-03-30",{"date":100,"type":36},"2026-04-01",{"date":102,"type":22},"2027-01",{"date":104,"type":22},"2027-07",{"name":42,"class":43},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":16,"sex":17,"minAge":113,"maxAge":19,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":76},"100632081","phase-2-age-descending-study-to-evaluate-the-safety-and-immunogenicity-of-the-cholera-conjugate-vaccine-in-adults-and-children-100632081","NCT07509047","Age-descending Study to Evaluate the Safety and Immunogenicity of the Cholera Conjugate Vaccine in Adults and Children","A Phase II, Randomized, Controlled, Age-descending Study in Adults and Children to Evaluate the Safety and Immunogenicity of the OSP:rTTHc Cholera Conjugate Vaccine in Cholera-endemic Region","Inclusion Criteria:\n\n1. Individuals aged 1 to 45 years at consent\n2. Participants\u002F Participants' legally authorized representative (LAR) willing to provide written informed consent to participate in the study voluntarily\n3. Participants who can comply with the study requirements\n4. Individuals in good health as determined by the outcome of medical history, physical examination, and the clinical judgment of the investigator\n\nExclusion Criteria:\n\n1. Known history or allergy to investigational vaccine components or other medications, or any other allergies\n2. Individuals with major congenital abnormalities\n3. Known history of immune function disorders including immunodeficiency diseases (known HIV infection¥ or other immune function disorders)\n4. Use of systemic steroids within past 6 months (\\>10 mg\u002Fday prednisone equivalent for periods exceeding 2 consecutive weeks), or receive chemotherapy, radiation therapy or other immunosuppressive drugs within the past 6 months.\n5. Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the study objectives\n6. Individuals with behavioral or cognitive impairment or psychiatric disease or neural disorders that, in the opinion of the investigator, could interfere with the participant's ability to participate in the trial\n7. Individuals with splenectomy\n8. Individuals with known bleeding disorders\n9. Receipt of blood, blood-derived products, or immunoglobulin products in the past 3 months\n10. Individuals who have received other vaccines from 4 weeks prior to the first dose of test vaccination or planned to receive any vaccine within 4 weeks of the last dose of the investigational product.\n11. Individuals with active or known previous Vibrio cholerae infection\n12. Individuals with a history of severe diarrhea in the last 6 months requiring care at a medical facility lasting 24 hours or more\n13. Individuals with prior receipt of a cholera vaccine in the last 5 years\n14. Any female participant who is lactating or pregnant\n15. Females of childbearing potential who do not agree to use an effective birth control method for at least 4 weeks before the screening and up to 12 weeks after the study vaccination.\n16. Individuals enrolled in another clinical trial within 6 months prior to enrollment, concomitantly enrolled or scheduled to be enrolled in another trial during study period\n17. Individuals who are research staff involved with the clinical trial or family\u002Fhousehold members of research staff\n18. As per Investigator's medical judgement, an individual could also be excluded from the study despite meeting all inclusion\u002Fexclusion criteria mentioned above\n19. Children below 5 years old with Weight for Height Z score and\u002For Height for Age Z score of less than -2","1 Year",{"count":115,"type":22},390,[26],"This phase II study is intended to determine the immunogenicity and safety of single dose and two doses of OSP:rTTHc cholera conjugate vaccine (CCV) with or without alum adjuvant. The study will guide the future dosing schedule and formulation of CCV (with or without Aluminum phosphate adjuvant) expected to be needed in adults and children in cholera-endemic region.",[119],"Cholera Vaccination",[121,122,123,124],"Cholera Conjugate Vaccine","O Specific Polysaccharide","Recombinant Tetanus Toxoid Heavy Chain Fragment","Cholera Vaccine","2026-03-27",{"date":127,"type":36},"2026-04-03",{"date":129,"type":36},"2026-01-13",{"date":131,"type":22},"2027-12",{"name":42,"class":43},{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":144,"conditions":145,"keywords":149,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":76},"100624963","effectiveness-of-malaria-vaccines-in-reducing-the-risk-of-invasive-non-typhoidal-salmonella-disease-100624963","NCT07416461","Effectiveness of Malaria Vaccines in Reducing the Risk of Invasive Non-typhoidal Salmonella Disease","Effectiveness of Malaria Vaccines in Reducing the Risk of Invasive Non-Typhoidal Salmonella Disease (VINS)","VINS","Inclusion Criteria:\n\n1. Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with objective fever of at least 38.0°C tympanic or 37.5 °C axillary OR\n2. Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with reported fever ≥3 consecutive days within 7 days of presentation",{"count":142,"type":22},10000,"OBSERVATIONAL","The goal of this observational study is to learn about the impact of malaria vaccination on the risk of invasive non-typhoidal Salmonella disease in children below the age of 5. Eligible participants residing in the Kisantu Health Zone (DRC) and presenting fever are enrolled in healthcare facilities and tested for malaria and iNTS. Using a case-control (test-negative) design, the researchers will look at the malaria vaccination status of participants with and without iNTS infection to determine if the malaria vaccine protects against iNTS.",[146,147,148],"Invasive Non-Typhoidal Salmonella Disease","Malaria","Malaria Vaccine",[147,150,151,146,152,153,154,155,156],"Vaccine effectiveness","iNTS","DRC","Democratic Republic of Congo","Malaria vaccine","Effectiveness","R21\u002FMatrix-M","2026-02-10",{"date":159,"type":36},"2026-02-18",{"date":161,"type":36},"2025-10-27",{"date":163,"type":22},"2027-02",{"name":42,"class":43},{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":16,"sex":17,"minAge":113,"maxAge":19,"enrollmentInfo":172,"targetDuration":4,"studyType":23,"phases":174,"briefSummary":176,"conditions":177,"keywords":178,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":191,"locationsCount":192},"100616336","phase-3-trial-to-evaluate-immunogenicity-non-inferiority-safety-and-lot-to-lot-consistency-of-biovac-ocv-s-to-euvichol-plus-100616336","NCT07304284","Trial to Evaluate Immunogenicity Non-Inferiority, Safety and Lot-to-Lot Consistency of Biovac OCV-S to Euvichol®-Plus","Phase I\u002FIII, Multicenter, Observer-Blinded, Randomized, Active Controlled Trial to Evaluate Immunogenicity Non-Inferiority, Safety and Lot-to-Lot Consistency of Biovac OCV-S to Euvichol®-Plus in 1 to 45 Years Old South Africans","Inclusion Criteria:\n\nInclusion Criteria (for healthy\u002FHIV-negative cohorts A, B and C)\n\n1. Healthy participants aged 1 to 45 years at consent\n2. Participants\u002FParent(s)\u002FLegally Authorized Representative (LAR) willing to provide informed consent\u002Fassent\n3. HIV negative\n4. Not pregnant or lactating\n\nInclusion Criteria (for PLWH (HIV-positive) cohort AA)\n\n1. PLWH adults aged 18 to 45 years at consent\n2. Participants on anti-retroviral (ARV) therapy with CD4 counts \\>350 and viral loads that are undetectable.\n3. Not pregnant or lactating\n\nExclusion Criteria:\n\n1. Known history or allergy to investigational vaccine components, other preventive vaccines, or any other allergies\n2. Individuals with major congenital abnormalities\n3. Known history of immune function disorders including immunodeficiency diseases (known HIV infection in healthy participant cohorts) or other immune function disorders (all cohorts).\n4. Use of systemic steroids within past 6 months (\\>10 mg\u002Fday prednisone equivalent for periods exceeding 2 consecutive weeks), or receive chemotherapy, radiation therapy or other immunosuppressive drugs within the past 6 months.\n5. Behavioral or cognitive impairment, chronic substance abuse, or psychiatric disease or neurological disorders.\n6. Individuals with a known bleeding disorder.\n7. Receipt of blood, blood-derived products, or immunoglobulin products in the past 3 months.\n8. Individuals who have received other vaccines from 4 weeks prior to or within 4 weeks after any dose of the investigational product.\n9. Individuals with active or previous Vibrio cholerae infection.\n10. Individuals with receipt of a cholera vaccine in the past 5 years.",{"count":173,"type":22},2824,[175],"PHASE3","This Phase I\u002FIII clinical trial is intended to establish the immunogenicity and safety profile of Biovac OCV-S compared to available WHO pre-qualified vaccine Euvichol®-Plus in healthy adults and children and in adult people living with HIV (PLWH). The lot-to-lot consistency of Biovac OCV-S in healthy adults will also be determined.",[119],[179,180,181,182,183,184],"Biovac OCV-S","Euvichol®-Plus","IVI BIOVAC OCV-S 001","International Vaccine Institute (IVI)","Biovac Institute","South African Medical Research Council (SAMRC)","2026-01-08",{"date":187,"type":36},"2026-01-12",{"date":189,"type":36},"2025-10-31",{"date":163,"type":22},{"name":42,"class":43},5,{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":16,"sex":17,"minAge":113,"maxAge":4,"enrollmentInfo":201,"targetDuration":203,"studyType":143,"phases":4,"briefSummary":204,"conditions":205,"keywords":208,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":76},"100600130","evaluation-of-effectiveness-and-safety-of-lc16m8-mpox-vaccine-in-the-democratic-republic-of-congo-drc-100600130","NCT07093489","Evaluation of Effectiveness and Safety of LC16m8 Mpox Vaccine in the Democratic Republic of Congo (DRC)","Evaluation of the Effectiveness and Safety of the LC16m8 Mpox Vaccine in Individuals Aged One Year and Older in the Democratic Republic of Congo (DRC)","MPX-001","1. Vaccination:\n\n   Inclusion criteria\n   * Individuals aged 12 months and above\n   * Living in the study catchment area\n   * Written informed consent\u002Fassent (if applicable)\n\n   Exclusion criteria\n   * Prior receipt of any mpox vaccine dose\n   * Women known to be pregnant or breast feeding\n   * Individuals suffering from any spreading skin disease\n   * Immunocompromised individuals with known severe immuno-deficiency conditions (example, HIVAIDS, individuals being on chronic use of systemic steroids (\\>2 mg\u002Fkg\u002Fday or \\>20 mg\u002Fday prednisolone equivalent for periods exceeding 10 days, cytotoxic or other immunosuppressive drugs)\n   * Individuals with known underlying uncontrolled chronic diseases such as diabetes mellitus, cardiovascular disease, renal disease, hepatic disease, hematological disease, and developmental disturbance\n   * Individuals with a history of hypersensitivity caused by a component of the vaccine\n\n   Temporary exclusion criteria\n   * Individuals with objective fever (Frontal temperature ≥ 38.5°C) or axillary temperature \\> 37.5 °C\n   * Individuals suffering from acute illness within 48 hours prior to vaccination and based on investigator judgement.\n   * Receipt of any live vaccine injection within the previous 27 days (measles vaccine, rubella vaccine, mumps vaccine, varicella vaccine, BCG vaccine, yellow fever vaccine...).\n2. Cohort Event Monitoring (CEM):\n\n   Inclusion criteria\n   * Written informed consent\n   * Individual who receives single dose of LC16m8 vaccine at one of the vaccination centers participating in the study.\n   * Must be reachable by phone (must have an active phone number of his\u002Fher own or in the household) throughout study participation.\n\n   Exclusion criteria\n\n   • Individual\u002Fparent\u002Fguardian unable to comply with the study procedures\n3. Mpox surveillance (VE):\n\nGeneral Inclusion Criteria:\n\n* Patients (with any vaccination status) presenting to a sentinel surveillance health facility with clinical signs and symptoms consistent with mpox disease (probable or suspected)\n* Reside in the study area prior to testing.\n* Eligible to receive LC16m8 vaccine during the vaccination.\n* Give consent\u002Fassent (if applicable) to participate in the study.\n\nExclusion Criteria\n\n* Individuals meeting any of the following criteria are not eligible for testing and enrollment in the study:\n* Known contraindications for LC16m8 vaccine.\n* As per the Investigator's medical judgement, an individual could be excluded from the study despite meeting all the inclusion\u002Fexclusion criteria mentioned above.",{"count":202,"type":22},11990,"12 Weeks","This is a health facility-based prospective test-negative (TND) case-control study to evaluate vaccine effectiveness and active safety monitoring (cohort event monitoring), and passive surveillance for evaluation of the safety of the LC16m8 mpox vaccine in individuals aged one year and older in the DRC.\n\nThis study aims to assess the LC16m8 vaccine effectiveness and safety. The following activities will be carried out:\n\n* Community engagement\n* Enhanced health facility-based mpox disease surveillance\n* Vaccination using the LC16m8 vaccine\n* Safety monitoring following immunization\n* LC16m8 Vaccine effectiveness evaluation using a TND\n\nStudy Hypothesis: The LC16m8 vaccine, administered as pre-exposure prophylaxis, confers greater than 70% protection against symptomatic mpox disease among adults and children in the DRC.",[206,207],"Mpox (Monkeypox)","Mpox",[209,207,155,210,152],"LC16m8","Safety","2025-09-08",{"date":213,"type":36},"2025-09-15",{"date":215,"type":22},"2025-09-30",{"date":217,"type":22},"2027-12-31",{"name":42,"class":43},{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":223,"acronym":61,"eligibilityCriteria":224,"healthyVolunteers":16,"sex":225,"minAge":226,"maxAge":227,"enrollmentInfo":228,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":230,"conditions":231,"keywords":233,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":243,"locationsCount":244},"100526016","global-burden-estimation-of-human-papillomavirus-globe-hpv-100526016","NCT06129253","Global Burden Estimation of Human Papillomavirus (GLOBE-HPV)","Inclusion Criteria:\n\n1. 9 to 50 years old (for urban and rural CSSs) at the time of enrollment.\n2. Resident in the selected community for at least the past 3 months (with the exception of pastoralists, refugees, and commercial sex workers).\n3. Able to understand the purpose of the study and study procedures.\n4. If aged 18 years or older or legally considered an emancipated minor, able and willing to provide consent to participate in the study including sample collection.\n5. If aged \\\u003C18 years (and not considered an emancipated minor), supported in their participation by a parent or guardian who is able and willing to provide consent, and\n6. If aged \\\u003C18 years (and not considered an emancipated minor), able and willing to provide assent to participate in the study.\n\nExclusion Criteria:\n\n1. Decline consent to participate any activity of the study.\n2. A medical condition or other reason, not directly related to HPV infection or HPV-related diseases, in the opinion of the investigator, precludes enrolment in the study.","FEMALE","9 Years","50 Years",{"count":229,"type":22},29750,"This study is a multi-country and multi-site project to estimate the point-prevalence of high-risk (HR) HPV genotype infections among representative samples of girls and women aged 9-50 years, and among specific sub-populations to estimate the incidence of persistent HPV infection among sexually active young women. The data to fulfill the objectives will be collected through a series of Cross-Sectional Surveys (CSS) and Longitudinal Studies (LS) in all 8 countries 3 South Asian countries including Bangladesh, Pakistan, Nepal and 5 sub-Saharan African countries including Sierra Leone, Tanzania, Ghana, Zambia and DR Congo. Qualitative sub-studies (QS) will be conducted in selected countries and populations following the CSS to further understand and unpack risk factors for HPV infection as well as to explore how gender-related dynamics including perceptions of gender norms and stigma, influence HPV burden and\u002For create barriers that shape girls\u002Fwomen access to and uptake of HPV prevention, screening, and treatment services. Specific study protocols and corresponding ethical applications for the qualitative sub-studies will be developed separately.",[232],"HPV Infection",[234,232,235,236],"HPV Positivity","High Risk (HR) HPV","Cervical Cancer","2025-07-15",{"date":239,"type":36},"2025-07-16",{"date":241,"type":36},"2023-11-23",{"date":131,"type":22},{"name":42,"class":43},8,{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":16,"sex":17,"minAge":252,"maxAge":19,"enrollmentInfo":253,"targetDuration":4,"studyType":23,"phases":255,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":267},"100539619","phase-2-immunogenicity-and-safety-of-hecolin-in-hiv-positivenegative-adults-and-in-children-100539619","NCT06306196","Immunogenicity and Safety of Hecolin® in HIV Positive\u002FNegative Adults and in Children","A Phase 2b, Open-label Study to Evaluate the Immunogenicity and Safety of Hecolin® in HIV Positive\u002FNegative Adult Participants Followed by a Randomized, Placebo-controlled, Observer-blind Study to Evaluate the Immunogenicity and Safety of Hecolin® in Children","Inclusion Criteria (healthy participants only):\n\n1. Healthy participants 2 to 45 years of age at enrollment,\n2. Participants\u002FParent(s)\u002FLAR who have voluntarily given informed consent\u002Fassent,\n3. Participants\u002FParent(s)\u002FLAR willing to follow the study procedures and available for the entire duration of the study and agrees to the collection of all biospecimens,\n4. HIV negative,\n5. Not pregnant,\n6. Agreement to practice effective contraception for female participants of childbearing potential and non-sterile males until at least 8 months after the first vaccination.\n7. Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose of vaccine, and\n8. Female participant not currently breastfeeding.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Has received any hepatitis E vaccine in the past,\n2. Febrile illness (body temperature ≥ 38°C) or acute illness within 3 days prior to the study vaccination,\n3. Known history or allergy to study vaccine components and\u002For excipients or other medications, or any other allergies or medical history deemed by the investigator to increase the risk of an adverse event if they were to participate in the trial (e.g., Guillain-Barre Syndrome),\n4. Major congenital abnormalities which in the opinion of the investigator may affect the participant's participation in the study,\n5. Known history of immune function disorders including immunodeficiency diseases (known HIV infection or other immune function disorders) and lupus,\n6. Chronic use of systemic steroids (\\>2 mg\u002Fkg\u002Fday or \\>20 mg\u002Fday prednisone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs within the past 6 weeks,\n7. Any abnormality or chronic disease which in the opinion of the investigator might be detrimental to the safety of the participant and interfere with the assessment of the study objectives,\n8. Behavioral or cognitive impairment, chronic substance abuse, or psychiatric disease or neural disorders, that, in the opinion of the investigator, could interfere with the participant's ability to participate in the trial,\n9. History of splenectomy,\n10. History of thrombocytopenia and\u002For thrombosis, myocarditis or pericarditis or any other significant cardiac condition,\n11. With a known bleeding diathesis or any condition that may be associated with a prolonged bleeding time resulting in contraindication for IM injections\u002Fblood extractions.,\n12. Receipt of blood or blood-derived products in the past 3 months,\n13. Receipt of other vaccines from 4 weeks prior to test vaccination or planned to receive any vaccine within 4 weeks of last dose of study vaccine,\n14. Concomitantly enrolled or scheduled to be enrolled in another trial,\n15. Research staff involved with the clinical study or family\u002Fhousehold members of research staff,\n16. Body mass index (BMI) of ≥ 40 in adults and for children a BMI- index-for-age is ≥95th percentile, at the time of the screening visit, or\n17. As per the Investigator's medical judgement, an individual could be excluded from the study despite meeting all inclusion\u002Fexclusion criteria mentioned above.\n\nInclusion criteria for HIV-positive arm:\n\n1. Adults 18-45 years living with HIV on anti-retroviral (ARV) treatment and willing to have CD4 and viral load measured as per protocol,\n2. Able to provide a voluntary signed informed consent,\n3. Participants willing to follow the study procedures of the study and available for the entire duration of the study and agrees to the collection of all biospecimens,\n4. Agreement to practice effective contraception for female participants of childbearing potential and non-sterile males until at least 3 months after the last vaccination.\n5. Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the last dose of vaccine, and\n6. Female participant is currently not breastfeeding.\n\nExclusion Criteria for HIV-positive arm:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Has received any hepatitis E vaccine in the past,\n2. Newly diagnosed HIV-positive (diagnosed on screening) on ARVs for 0-4 weeks (Note: These participants can be re-screened and enrolled once they have been on ARVs for 4 weeks),\n3. Febrile illness (body temperature ≥ 38°C) or acute illness within 3 days prior to the study vaccination,\n4. Serious adverse reaction to any vaccine, or any component of the investigational vaccine, including a history of anaphylaxis and symptoms of a severe allergic reaction and history of allergies in the past,\n5. Current hospitalization,\n6. History of inherited blood disorders, heparin-induced thrombocytopenia, or thromboembolic disorders,\n7. History of any blood product transfusion up to 6 months before enrolment,\n8. Receipt of other vaccines from 4 weeks prior to test vaccination or planned to receive any vaccine within 4 weeks of last dose of study vaccine\n9. Currently taking anti-coagulation therapy, or chronic aspirin in the past 3 months,\n10. Pregnant or breastfeeding women throughout the study period,\n11. Extreme obesity (defined as BMI of 40 kg\u002Fm2 or higher),\n12. Chronic kidney disease requiring dialysis,\n13. Liver disease (Note mild chronic liver disease is not an exclusion criterion),\n14. Participants with acquired or hereditary immunodeficiencies other than HIV,\n15. History of hereditary, idiopathic, or acquired angioedema,\n16. No spleen or functional asplenia,\n17. Platelet disorder or other bleeding disorder that may cause injection contraindication,\n18. Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness including, but not limited to, systemic corticosteroids exceeding 10 mg\u002Fday of prednisone equivalent, allergy injections, immunoglobulin, interferon, or immunomodulators. The use of low dose topical, ophthalmic, inhaled, and intranasal steroid preparations will be permitted,\n19. According to the judgement of the investigator, the participant has any other factors that might interfere with the results of the clinical trial or pose additional risk due to participation in the study,\n20. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol","2 Years",{"count":254,"type":22},1040,[26],"The primary goal of this clinical trial is to demonstrate non-inferiority of 30 µg of Hecolin® in healthy children, compared to healthy adults as measured by seroresponse rates (SR) of anti-HEV IgG titers, 4 weeks after 3 doses (0, 1 and 6 months) and to assess and descriptively compare safety profile data intra and inter age Strata. As secondary objectives, Geometric Mean Concentration (GMC) of anti-HEV IgG ELISA will be evaluated 4 weeks after 3 doses (0, 1 and 6 months) and 4 weeks after 2 doses (0- and 6-months dose) in healthy children. SR and GMC will also be evaluated 24 weeks after 3 doses and 2 doses. The immune response will be compared among adult participants between HIV positive and HIV negative individuals and between virally suppressed and virally unsuppressed HIV positive individuals",[258],"Hepatitis E Virus Infection","2025-04-24",{"date":261,"type":36},"2025-04-29",{"date":263,"type":36},"2024-04-04",{"date":265,"type":22},"2026-01",{"name":42,"class":43},3,{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":16,"sex":17,"minAge":275,"maxAge":276,"enrollmentInfo":277,"targetDuration":4,"studyType":23,"phases":279,"briefSummary":280,"conditions":281,"keywords":283,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":4},"100577579","phase-1-hepatitis-b-vaccine-delivered-trans-dermally-by-map-100577579","NCT06800131","Hepatitis B Vaccine Delivered Trans-dermally by MAP","A Phase I, Randomized, Open-Label, Active-Control Study to Evaluate Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Delivered Trans-dermally by Microneedle Array Patch (MAP) in Healthy Adults","Inclusion Criteria:\n\n1. Able to communicate with investigator, and to provide informed consent and have signed Informed Consent Form (ICF) prior to screening procedures\n2. Adults aged 19 to 40 years\n3. Judged to be healthy by the Investigator on the basis of medical history, physical examination, screening laboratory results and vital signs performed at screening visit\n4. Able and willing to comply with all study procedures during the study period\n5. Negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis B surface antibody (Anti-HBs), antibody to Hepatitis B core antibody (anti-HBc), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody at screening\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding, or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit until 3 months following last dose\n2. Positive serum pregnancy test at screening or positive urine pregnancy test prior at dosing visit\n3. Self-reported history of Hepatitis B vaccination beyond childhood Hepatitis B immunization series\n4. Currently participating in or has participated in a study with an investigational product administered within 6 months preceding Day 0\n5. Body mass index (BMI) \\\u003C18 or \\>30 kg\u002Fm²\n6. Current or history of the following medical conditions:\n\n   * Diagnosis of malignancy within 5 years of screening\n   * Diagnosis of diabetes mellitus or HbA1c ≥7%\n   * Liver transaminases \\> 2 times the upper limit of the normal range\n   * Impaired renal function as creatinine \\>120 mmol\u002FL or calculated glomerular filtration rate \\\u003C60mls\u002Fmin\n   * Use of immunoglobulin or blood products in last 3 months\n   * History of severe allergic reaction or anaphylaxis after immunization or administration of any medical products that contain drug substances of investigational product","19 Years","40 Years",{"count":278,"type":22},40,[25],"This is Phase I, randomized, open-label, active-controlled study to evaluate the safety, tolerability, and immunogenicity of a hepatitis B vaccine administered trans-dermally via microneedle array patch (MAP) compared to the intra-muscular (IM) hepatitis B vaccine (Euvax B™), administered at Day (D) 0, Week (W) 4, W26 among healthy adults aged 19 to 40 years in the Republic of Korea.",[282],"Hepatitis B Vaccine",[284],"Microneedle array patch","2025-01-24",{"date":287,"type":36},"2025-01-29",{"date":289,"type":22},"2025-02-05",{"date":291,"type":22},"2026-11-05",{"name":42,"class":43},{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":16,"sex":225,"minAge":300,"maxAge":19,"enrollmentInfo":301,"targetDuration":4,"studyType":23,"phases":303,"briefSummary":304,"conditions":305,"keywords":307,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":76},"100501354","phase-2-safety-and-immunogenicity-of-hecolin-in-healthy-pregnant-women-100501354","NCT05808166","Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women","A Phase II, Randomized, Observer-blinded, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women Between Gestational Age 14-34 Weeks and Non-Pregnant Women of 16-45 Years Old.","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a pregnant\u002Fnon-pregnant woman must meet all of the following criteria:\n\nPregnant women only:\n\n1. Healthy women 16-45 years of age who are between 14 0\u002F7 and 34 6\u002F7 weeks gestation1 on the day of planned vaccination with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications for herself and her infant.\n2. Individual willing to provide written informed consent for herself and her infant to participate in the study.\n3. Individual who can be followed up during the study period and can comply with the study requirements.\n4. Individual and fetus in good health as determined by the outcome of medical history, physical examination, obstetric history, prenatal care (by ultrasound and other prenatal assessment subject to gestational age), vital signs, laboratory evaluations at screening and the clinical judgment of the investigator.\n5. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nNon-pregnant women only:\n\n1. Healthy women 16-45 years of age.\n2. Individual willing to provide written informed consent to participate in the study.\n3. Individual who can be followed up during the study period and can comply with the study requirements.\n4. Individual in good health as determined by the outcome of medical history, physical examination, vital signs, laboratory evaluations at screening and the clinical judgment of the investigator.\n5. Individuals who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n6. Females of childbearing potential with negative urinary pregnancy test on the day of screening.\n7. Females of childbearing potential who are using an effective birth control method2 for at least 4 weeks before the screening and up to 4 weeks after the last vaccination.\n\nExclusion Criteria:\n\nA pregnant\u002Fnon-pregnant woman who meets any of the following criteria will be excluded from participation in this study:\n\n1. Has received any hepatitis E vaccine in the past.\n2. Febrile illness (axillary temperature ≥ 38.5°C) or acute illness within 3 days prior to the study vaccination.\n3. Known history or allergy to study vaccine components and\u002For excipients or other medications, or any other allergies or medical history deemed by the investigator to increase the risk of an adverse event if they were to participate in the trial (e.g., Guillain-Barre Syndrome).\n4. Major congenital abnormalities which in the opinion of investigator may affect the participant's participation in the study.\n5. Known history of immune function disorders including immunodeficiency diseases (known HIV infection or other immune function disorders) and lupus.\n6. Chronic use of systemic steroids (\\>2 mg\u002Fkg\u002Fday or \\>20 mg\u002Fday prednisone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs within past 6 weeks.\n7. Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the study objectives.\n8. Behavioral or cognitive impairment, or chronic substance abuse, or psychiatric disease or neural disorders, that, in the opinion of the investigator, could interfere with the participant's ability to participate in the trial.\n9. History of splenectomy.\n10. Past history of thrombocytopenia and\u002For thrombosis, myocarditis or pericarditis or any other significant cardiac condition.\n11. With a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time resulting in contraindication for IM injections\u002Fblood extractions. (Those who receive low dose aspirin (less than 100mg\u002Fday) are not excluded)\n12. Receipt of blood or blood-derived products in the past 3 months.\n13. Receipt of other vaccines from 4 weeks prior to test vaccination or planned to receive any vaccine within 4 weeks of last dose of study vaccine\n14. As per Investigator's medical judgement, an individual could be excluded from the study in spite of meeting all inclusion\u002Fexclusion criteria mentioned above.\n15. Concomitantly enrolled or scheduled to be enrolled in another trial.\n16. Research staff involved with the clinical study or family\u002Fhousehold members of research staff.\n17. Body mass index (BMI) of ≥ 40, at the time of the screening visit.\n\nPregnant women only:\n\n1\\. Plans to terminate her pregnancy. Pregnancy complications (in the current pregnancy) such as preterm labor, gestational diabetes, hypertension (blood pressure (BP) \\> 140\u002F90 in the presence of proteinuria or BP \\> 150\u002F100 with or without proteinuria), or currently on an antihypertensive therapy, or pre-eclampsia, or evidence of intrauterine growth restriction.\n\n3\\. Prior stillbirth or neonatal death, or multiple (≥ 3) spontaneous abortions. 4. Prior preterm delivery ≤ 34 weeks gestation or having ongoing intervention (medical\u002Fsurgical) in current pregnancy to prevent preterm birth.\n\n5\\. Previous infant with a known genetic disorder or major congenital anomaly. 6. History of major gynecologic or major abdominal surgery (previous Caesarean section is not an exclusion) 7. Current pregnancy results from in vitro fertilization (IVF). 8. Current pregnancy results from rape or incest. 9. Plans to release the neonate for adoption or the neonate to be a ward of the state.\n\n10\\. Greater than 5 prior deliveries\n\nNon-pregnant women only:\n\n1\\. Pregnant or plan to be pregnant during the study period.","16 Years",{"count":302,"type":22},2358,[26],"This is a phase II randomized, observer-blinded, placebo-controlled study with 3 arms enrolling a total of 2,358 participants. The arms are composed of Arm 1, pregnant participants receiving Hecolin® (N=1,104) with immunogenicity subset (n=150), Arm 2, pregnant participants receiving placebo (N=1,104) with immunogenicity subset (n=150), and Arm 3, non-pregnant participants receiving Hecolin® (N=150) of which all participants in this arm will be included in the immunogenicity subset.",[306],"Hepatitis E Infection",[308,309,310,311],"Hepatitis E infection","Hepatitis E virus","Hepatitis E vaccine","Hepatitis E in pregnancy","2024-09-26",{"date":314,"type":36},"2024-09-27",{"date":316,"type":36},"2024-05-02",{"date":318,"type":22},"2026-04",{"name":42,"class":43},""]