[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580192":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":29,"locations":35,"responsibleParty":199,"collaborators":28,"id":201,"slug":202,"hasResults":203,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":28,"eligibilityCriteria":207,"healthyVolunteers":208,"sex":209,"minAge":210,"maxAge":211,"enrollmentInfo":212,"targetDuration":28,"studyType":215,"phases":216,"briefSummary":218,"conditions":219,"keywords":28,"overallStatus":50,"whyStopped":28,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":231},{"fullName":5,"class":6},"NPO Petrovax","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Stage I","EXPERIMENTAL","At this stage, adult volunteers aged 18-55 years old (inclusive) will be enrolled in the study. After screening procedures, 80 volunteers who meet the eligibility criteria and do not meet any non-eligibility criteria will be randomized into 2 groups in a 1: 1 ratio",[13],"Drug: polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y",{"label":15,"type":10,"description":16,"interventionNames":17},"Stage II","Stage II will begin after receiving the positive conclusion of the IDMC on the basis of the consideration of stage I data. At this stage, adolescents aged 11-17 years old (inclusive) will be included in the study. After screening procedures, 80 adolescents who meet the eligibility criteria and do not meet any non-eligibility criteria will be randomized into 2 groups in a 1:1 ratio",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Stage III","Stage III will begin after receiving the positive conclusion of the IDMC on the basis of the consideration of stage II data. At this stage, children aged 3-10 years old (inclusive) will be included in the study. After screening procedures, 80 children who meet the eligibility criteria and do not meet any non-eligibility criteria will be randomized into 2 groups in a 1:1 ratiowill receive Menactra® at a dose of 0.5 mL intramuscularly into the deltoid site.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y","Group 1 (n = 40) will receive GNG-DE at a dose of 0.5 mL intramuscularly into the deltoid site.\n\nGroup 2 (n = 40) will receive Menactra® at a dose of 0.5 mL intramuscularly into the deltoid site.",[9,15,19],null,[30],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"Kirill Klimkin","CONTACT","+7(495) 730-75-45","KlimkinKA@petrovax.ru",[36,48,62,67,77,87,95,105,113,118,128,138,148,161,174,178,191],{"facility":37,"status":38,"city":39,"state":28,"zip":28,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":28},"Federal State Budgetary Educational Institution of Higher Education \"Kirov State Medical University\" of the Ministry of Health of the Russian Federation","COMPLETED","Kirov","Russia","RU",{"type":43,"coordinates":44},"Point",[45,46],49.65783,58.59809,{"lat":46,"lon":45},{"facility":49,"status":50,"city":51,"state":28,"zip":28,"country":40,"countryCode":41,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Federal Budgetary Scientific Institution \"Central Research Institute of Epidemiology\" of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing","RECRUITING","Moscow",{"type":43,"coordinates":53},[54,55],37.61781,55.75204,{"lat":55,"lon":54},[58],{"name":59,"role":32,"phone":60,"phoneExt":28,"email":61},"Aleksandr Gorelov, Doctor of Medical Sciences","+7(495)6721158","agorelov_05@mail.ru",{"facility":63,"status":38,"city":51,"state":28,"zip":28,"country":40,"countryCode":41,"cosmosGeoPoint":64,"geoPoint":66,"contacts":28},"Federal State Budgetary Scientific Institution \"I.I. Mechnikov Research Institute of Vaccines and Serums\"",{"type":43,"coordinates":65},[54,55],{"lat":55,"lon":54},{"facility":68,"status":50,"city":51,"state":28,"zip":28,"country":40,"countryCode":41,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"Federal State Budgetary Scientific Institution \"Russian Scientific Center of Surgery named after Academician B.V. Petrovsky\"",{"type":43,"coordinates":70},[54,55],{"lat":55,"lon":54},[73],{"name":74,"role":32,"phone":75,"phoneExt":28,"email":76},"Leyla Namazova-Baranova, Doctor of Medical Sciences","+7(495) 1320203","leyla.s.namazova@gmail.com",{"facility":78,"status":50,"city":51,"state":28,"zip":28,"country":40,"countryCode":41,"cosmosGeoPoint":79,"geoPoint":81,"contacts":82},"State Budgetary Institution of Healthcare of the City of Moscow \"Morozovskaya Children's City Clinical Hospital of the Moscow City Healthcare Department\"",{"type":43,"coordinates":80},[54,55],{"lat":55,"lon":54},[83],{"name":84,"role":32,"phone":85,"phoneExt":28,"email":86},"Alexey Rtishchev, Candidate of Medical Sciences","+7(495)9598801","rtishchev@inbox.ru",{"facility":88,"status":38,"city":89,"state":28,"zip":28,"country":40,"countryCode":41,"cosmosGeoPoint":90,"geoPoint":94,"contacts":28},"Federal State Budgetary Educational Institution of Higher Education \"Perm State Medical University named after Academician E.A. Wagner\" of the Ministry of Health of the Russian Federation","Perm",{"type":43,"coordinates":91},[92,93],56.25017,58.01046,{"lat":93,"lon":92},{"facility":96,"status":50,"city":89,"state":28,"zip":28,"country":40,"countryCode":41,"cosmosGeoPoint":97,"geoPoint":99,"contacts":100},"State Budgetary Healthcare Institution of Perm Krai \"City Children's Clinical Polyclinic No. 5\"",{"type":43,"coordinates":98},[92,93],{"lat":93,"lon":92},[101],{"name":102,"role":32,"phone":103,"phoneExt":28,"email":104},"Olga Perminova, Candidate of Medical Sciences","+7(342)2280925","perminova20062006@yandex.ru",{"facility":106,"status":38,"city":107,"state":28,"zip":28,"country":40,"countryCode":41,"cosmosGeoPoint":108,"geoPoint":112,"contacts":28},"Federal State Budgetary Institution \"A. A. Smorodintsev Research Institute of Influenza\" of the Ministry of Health of the Russian Federation","Saint Petersburg",{"type":43,"coordinates":109},[110,111],30.31413,59.93863,{"lat":111,"lon":110},{"facility":114,"status":38,"city":107,"state":28,"zip":28,"country":40,"countryCode":41,"cosmosGeoPoint":115,"geoPoint":117,"contacts":28},"Federal State Budgetary Institution \"Children's Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency\"",{"type":43,"coordinates":116},[110,111],{"lat":111,"lon":110},{"facility":119,"status":50,"city":107,"state":28,"zip":28,"country":40,"countryCode":41,"cosmosGeoPoint":120,"geoPoint":122,"contacts":123},"Limited Liability Company \"Energy of Health\"",{"type":43,"coordinates":121},[110,111],{"lat":111,"lon":110},[124],{"name":125,"role":32,"phone":126,"phoneExt":28,"email":127},"Svetlana Lazareva","+7(812)3352958","alexlaz58@rambler.ru",{"facility":129,"status":50,"city":107,"state":28,"zip":28,"country":40,"countryCode":41,"cosmosGeoPoint":130,"geoPoint":132,"contacts":133},"Limited Liability Company \"PiterClinic\"",{"type":43,"coordinates":131},[110,111],{"lat":111,"lon":110},[134],{"name":135,"role":32,"phone":136,"phoneExt":28,"email":137},"Tatiana Pak, Candidate of Medical Sciences","+7 (812) 9818284","pte@list.ru",{"facility":139,"status":50,"city":107,"state":28,"zip":28,"country":40,"countryCode":41,"cosmosGeoPoint":140,"geoPoint":142,"contacts":143},"Saint Petersburg State Budgetary Healthcare Institution \"Children's City Polyclinic No. 44\"",{"type":43,"coordinates":141},[110,111],{"lat":111,"lon":110},[144],{"name":145,"role":32,"phone":146,"phoneExt":28,"email":147},"Olga Trusova, Doctor of Medical Sciences","+7(812)4174002","o-tru@mail.ru",{"facility":149,"status":50,"city":150,"state":28,"zip":28,"country":40,"countryCode":41,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Federal State Budgetary Educational Institution of Higher Education \"National Research Mordovian State University named after N.P. Ogarev\"","Saransk",{"type":43,"coordinates":152},[153,154],45.17166,54.18485,{"lat":154,"lon":153},[157],{"name":158,"role":32,"phone":159,"phoneExt":28,"email":160},"Svetlana Garina, Candidate of Medical Sciences","+7(8342)353002","astra-svet@rambler.ru",{"facility":162,"status":50,"city":163,"state":28,"zip":28,"country":40,"countryCode":41,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Limited Liability Company \"DNA Research Center\"","Saratov",{"type":43,"coordinates":165},[166,167],45.9901,51.54048,{"lat":167,"lon":166},[170],{"name":171,"role":32,"phone":172,"phoneExt":28,"email":173},"Lubov Aleshina, Candidate of Medical Sciences","+7(8452)756292","lubov-sk@mail.ru",{"facility":162,"status":38,"city":163,"state":28,"zip":28,"country":40,"countryCode":41,"cosmosGeoPoint":175,"geoPoint":177,"contacts":28},{"type":43,"coordinates":176},[166,167],{"lat":167,"lon":166},{"facility":179,"status":50,"city":180,"state":28,"zip":28,"country":40,"countryCode":41,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Federal State Budgetary Educational Institution of Higher Education \"Smolensk State Medical University\" of the Ministry of Health of the Russian Federation","Smolensk",{"type":43,"coordinates":182},[183,184],32.05088,54.77826,{"lat":184,"lon":183},[187],{"name":188,"role":32,"phone":189,"phoneExt":28,"email":190},"Elena Kozlova, Candidate of Medical Sciences","+7(4812)381412","keu83smol@yandex.ru",{"facility":192,"status":38,"city":193,"state":28,"zip":28,"country":40,"countryCode":41,"cosmosGeoPoint":194,"geoPoint":198,"contacts":28},"State Budgetary Healthcare Institution of the Sverdlovsk Region \"Central City Hospital No. 7, Yekaterinburg\"","Yekaterinburg",{"type":43,"coordinates":195},[196,197],60.61529,56.85733,{"lat":197,"lon":196},{"type":200,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100580192","phase-3-assessment-of-immunogenicity-reactogenicity-and-safety-of-the-drug-gng-de-in-comparison-with-the-reference-drug-100580192",false,"NCT06834100","Assessment of Immunogenicity, Reactogenicity and Safety of the Drug GNG-DE in Comparison With the Reference Drug","Simple Blinded Multicenter Randomized Comparative Study to Assess Immunogenicity, Reactogenicity and Safety of the Drug GNG-DE","Inclusion Criteria:\n\n1. Male and female subjects aged 3-55 years old inclusive at the time of screening beginning.\n2. Availability of a signed Volunteer Informed Consent Form (Volunteer Information Sheet, VIS) (for participants aged 7-55 years inclusive) and\u002For the parent\u002Fadoptive parent informed consent form (Parent Information Sheet, PIS) signed by one of parents\u002Fadoptive parents (for participants aged 3-17 years old inclusive).\n3. Negative result of SARS-CoV-2 antigen rapid test at screening.\n4. Negative pregnancy test result in fertile females of reproductive age. For females not reached puberty, and for girls\u002Fwomen unable to childbirth (with past infertility, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, menopause for more than 2 years), the pregnancy test shall not be performed.\n5. For participants of 14-55 years old inclusive with preserved reproductive function, the consent to use of reliable methods of contraception (abstinence, condoms in combination with spermicide and\u002For hormonal contraception) during the study.\n\n   For participants aged 3-13 years old inclusive and females incapable of childbearing, the consent to use reliable methods of contraception is not required.\n6. The consent of a participant and\u002For a parent\u002Fan adoptive parent of a participant to cooperate in good faith with the investigator and the center staff, come to appointed visits, fill out the observation diary and comply with the requirements of the Protocol.\n\nExclusion Criteria:\n\n1. Hypersensitivity to any component of the test\u002Freference drug.\n2. Evident severe systemic reactions to any vaccines in anamnesis.\n3. Impossibility of intramuscular injections.\n4. Changes in the skin (pigmentation, tattoo, scars etc.) at the planned injection site of the test\u002Freference drug (the deltoid muscle area).\n5. Acute infectious and non-infectious diseases, exacerbation of chronic diseases at screening or less than 14 days before screening.\n6. Body temperature measured in the armpit ≥ 37.0°C at Visits 0 and 1.\n7. The history of chronic diseases that are significant in the opinion of the investigator (for example, malignant neoplasms, blood diseases, autoimmune diseases, immunodeficiencies, etc.).\n8. The history of meningococcal infection.\n9. Contact with a person with the confirmed infection caused by N. meningitidis less than 2 months before screening.\n10. The history of convulsive syndrome or the advanced neurological disease.\n11. The history of Guillain-Barré syndrome.\n12. The history of mental diseases.\n13. Drug administration:\n\n    * the history of meningococcal mono- or polyvalent vaccine, influenza vaccine within 14 days before screening, other vaccines within 30 days before screening;\n    * immunostimulants less than 30 days before screening;\n    * the immunosuppressive therapy, including systemic corticosteroids, prescribed for more than 5 days, or in the daily dose of more than 1 mg\u002Fkg\u002Fday of prednisolone or its equivalent - less than 30 days before screening;\n    * antipyretics, analgesics - for less than 24 hours before Visits 0 and 1;\n    * systemic antibacterial drugs-- for less than 72 hours before Visits 0 and 1;\n    * anticoagulants - for less than 3 weeks before Visits 0 and 1;\n    * immunoglobulins, blood or plasma products - for less than 3 months before Visits 0 and 1.\n14. Planning the administration of vaccines with the exception of the test\u002Freference drug during the clinical study.\n15. Surgical interventions performed less than 3 months before screening.\n16. Participation in another clinical study less than 30 days before screening.\n17. Other conditions that, in the opinion of the investigator, interfere to the enrollment.",true,"ALL","3 Years","55 Years",{"count":213,"type":214},240,"ESTIMATED","INTERVENTIONAL",[217],"PHASE3","Assessment of immunogenicity, reactogenicity and safety of GNG-DE in comparison with the reference drug",[220,221],"Infections","Meningococcal","2025-12-24",{"date":224,"type":225},"2025-12-29","ACTUAL",{"date":227,"type":225},"2025-02-12",{"date":229,"type":214},"2025-12-31",{"name":5,"class":6},17]