[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578787":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":34,"locations":41,"responsibleParty":57,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":30,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":30,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":91,"whyStopped":30,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"International Centre for Diarrhoeal Disease Research, Bangladesh","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Test (MR+YF)","EXPERIMENTAL","Based on randomization (n= 510) potential participants will be vaccinated with MR+YF on Day 0. A diary card will be provided. A blood sample (4-5 ml) will be collected for immunological assay on Day -1, Week 6 ±3 days, and Week 26 ±7 days. All details will be recorded in the eCRF.",[13,14],"Biological: Measles-Rubella vaccine (Live) I.P. (Freeze Dried) of M\u002Fs. Zydus Lifesciences Ltd","Biological: Yellow fever Vaccine (WHO prequalified)",{"label":16,"type":10,"description":17,"interventionNames":18},"Reference 1 (MR)","Based on randomization (n= 510) potential participants will be vaccinated with MR on Day 0. A diary card will be provided. A blood sample (4-5 ml) will be collected for immunological assay on Day -1, Week 6 ±3 days, and Week 26 ±7 days. All details will be recorded in the eCRF.",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"Reference 2 (YF)","PLACEBO_COMPARATOR","Based on randomization (n= 510) potential participants will be vaccinated with YF on Day 0. A diary card will be provided. A blood sample (4-5 ml) will be collected for immunological assay on Day -1, Week 6 ±3 days, and Week 26 ±7 days. All details will be recorded in the eCRF.",[14],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BIOLOGICAL","Measles-Rubella vaccine (Live) I.P. (Freeze Dried) of M\u002Fs. Zydus Lifesciences Ltd","Live attenuated vaccine",[16,9],null,{"type":26,"name":32,"description":28,"armGroupLabels":33,"otherNames":30},"Yellow fever Vaccine (WHO prequalified)",[20,9],[35],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Dr. Firdausi Qadri, PhD","CONTACT","88029827001-10","2431","fqadri@icddrb.org",[42],{"facility":43,"status":30,"city":44,"state":30,"zip":30,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Icddr,B","Dhaka","Bangladesh","BD",{"type":48,"coordinates":49},"Point",[50,51],90.40744,23.7104,{"lat":51,"lon":50},[54],{"name":55,"role":37,"phone":30,"phoneExt":30,"email":56},"Dr Farhana Khanam, PhD","farhanak@icddrb.org",{"type":58,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[60],{"name":61,"class":62},"Zydus Lifesciences Limited","INDUSTRY","100578787","phase-3-non-interference-study-of-mr-and-yellow-fever-vaccines-among-bangladeshi-infants-aged-9-12-months-100578787",false,"NCT06815835","Non-interference Study of MR and Yellow Fever Vaccines Among Bangladeshi Infants Aged 9-12 Months","A Prospective, Randomized, Parallel, Three-arm, Open-label, Clinical Trial to Evaluate the Immunological Non-interference of Measles and Rubella Vaccine (Live) I.P. (Freeze Dried) of M\u002Fs. Zydus Lifesciences Ltd. With Yellow Fever Vaccine Administered to Bangladeshi Healthy Infants Aged 9-12 Months","Inclusion Criteria:\n\n* The participant must satisfy all the following criteria to be eligible for enrolment:\n* Healthy infant participants of either gender aged\\* 9 to 12 months at the time of enrollment\n* Participants should be in good health as determined by the medical history and physical examination based on the clinical judgment of the investigator\n* No previous history of vaccination against measles, rubella, or Yellow fever\n* Written informed consent from the participant's parent\u002Fguardian\n* Participant's parent\u002Fguardian literate enough to fill the diary card \\*Age calculated as per completed month\n\nExclusion Criteria:\n\n* Participants positive for serological markers against Dengue and\u002For Japanese Encephalitis infections\n* History of hypersensitivity reaction to any component of the study vaccines including egg and chicken proteins\n* History of hypersensitivity reaction to neomycin\n* History of laboratory-confirmed or suspected measles, rubella, or Yellow fever in the past\n* Participant exposed# to measles, rubella, or Yellow fever virus within the past 30 days\n* Fever of any origin or infectious disorder of 3 days or more within the past month\n* Febrile illness (axillary temperature ≥37.5°C) at the time of enrollment\n* History of any vaccination within the past month\n* Clinically significant systemic disorders such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematological, immunological, or metabolic disorder\n* Confirmed or suspected immunosuppressive or immunodeficiency disorder; or participants on any immunosuppressive or immunostimulant therapy\n* Known case of thrombocytopenia or any coagulation disorder, or participants on anticoagulation therapy\n* Participants administered blood, blood-containing products, or immunoglobulins within the last 3 months or planned administration during the study\n* Participant participated in another clinical study in the past 3 months\n* Any other reason for which the investigator feels that the participant should not participate #Close contact (family member or neighbour) with laboratory-confirmed or clinical diagnosis of measles\u002Frubella\u002FYellow fever",true,"ALL","9 Months","12 Months",{"count":75,"type":76},1530,"ESTIMATED","INTERVENTIONAL",[79],"PHASE3","This study will be conducted among 1530 healthy infants of 9 to 12 months of age residing in the Dakshinkhan and Uttarkhan area which is located in Dhaka North City Corporation (DNCC) to enroll the required number of participants. Only infants who have not previously received the MR and YF vaccines will be enrolled. The findings of this study are likely to have a significant impact on vaccine co-administration strategies for campaign and routine immunization programs. The participants will be assigned to one of the three groups by the central computer-generated randomization schedule. The numbers are defined for each arm (Table 1) based on the sample size calculation. A list of infants who did not receive MR and Yellow fever vaccine will be prepared before enrollment by trained study staff (TSS). The TSSs will visit households in the defined study area and ask if the parents\u002Fguardians of infants aged 9-12 months are willing to participate in the study. If they show a willingness to participate, the TSSs will check their vaccination cards (if available) and prepare the list of potentially eligible infants who have not received MR and Yellow fever vaccines based on their vaccination card status. The investigators will collect blood specimens (4-5 ml) at the time of screening (visit-1), to evaluate serological markers of dengue and Japanese Encephalitis infection and for baseline (pre-vaccination) immunological assessment. The investigators will vaccinate seronegative, eligible participants within 24 hours of blood collection. There will be additional three follow-up visits after enrollment and will collect around 3-4 ml blood from each participant during visit 4 (week 6), and visit 5 (week 26) for immunological assessment. Diary cards will be used to collect adverse events (AEs) following immunization (AEFI) data for vaccinated participants (up to 14 days for solicited and 6 weeks for unsolicited AEs). Medically attended adverse events (MAAEs) and data on serious adverse events (SAEs) will be reported during the study. All study updates including AEs and SAEs will be reported to the data safety and monitoring board (DSMB) and sponsor.",[82,83,84],"Measles","Rubella","Yellow Fever",[86,87,88,89,90],"Safety","Non-interference","Measles and Rubella","Co-administration","Immunogenicity","NOT_YET_RECRUITING","2025-02-06",{"date":94,"type":95},"2025-02-07","ACTUAL",{"date":97,"type":76},"2025-04-01",{"date":99,"type":76},"2026-03-31",{"name":5,"class":6},1]