[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100411740":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":26,"locations":107,"responsibleParty":121,"collaborators":123,"id":129,"slug":130,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":26,"eligibilityCriteria":135,"healthyVolunteers":136,"sex":137,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":26,"studyType":143,"phases":144,"briefSummary":146,"conditions":147,"keywords":26,"overallStatus":150,"whyStopped":26,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Bharat Biotech International Limited","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Study vaccine","EXPERIMENTAL","BBV152B (6µg-Algel-IMDG)",[13],"Biological: BBV152",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Phosphate buffered saline with Alum (without antigen)",[19],"Biological: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","BBV152","BBV152 (6µg-Algel - Imidazoquinoline)",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Placebo (PBS+Alum, without antigen)",[15],[31,35,38,41,44,47,50,53,56,59,62,65,68,71,74,77,80,83,86,89,92,95,98,101,104],{"name":32,"affiliation":33,"role":34},"Dr Chadramani Singh","All India Institute of Medical Sciences","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"Dr Sanjay Kumar Rai","All India Institute of Medical Sciences Delhi",{"name":39,"affiliation":40,"role":34},"Dr Azhar Ali Khan","Baba Raghav Das Medical Gorakhpur",{"name":42,"affiliation":43,"role":34},"DrAnil Kumar Pandey","ESIC Medical College and Hospital Faridabad",{"name":45,"affiliation":46,"role":34},"Dr Simmi Dube","Gandhi Medical College, Bhopal",{"name":48,"affiliation":49,"role":34},"Dr Anjan Jyoti Talukdar","Gauhati Medical College & Hospital Assam",{"name":51,"affiliation":52,"role":34},"Dr Priti Meshram","Grant Government Medical College and Sir J.J. Group of Hospitals Mumbai",{"name":54,"affiliation":55,"role":34},"Dr Laxmi S Kumari","Guntur Medical College ,Guntur",{"name":57,"affiliation":58,"role":34},"Dr Shiva Narang","Guru Teg Bahadur Hospital",{"name":60,"affiliation":61,"role":34},"Dr E Venkat Rao","Institute of Medical Sciences and SUM Hospital Odisha",{"name":63,"affiliation":64,"role":34},"Dr P Venugopal","King George Hospital Visakhapatnam",{"name":66,"affiliation":67,"role":34},"Dr. N.T. Awad","Lokamanya tilak Municipal Medical College and General hospital Mumbai",{"name":69,"affiliation":70,"role":34},"Dr Pajanivel Ranganadin","Mahatma Gandhi Medical College& Research Institute Pondicherry",{"name":72,"affiliation":73,"role":34},"Dr Prabhakar Reddy","Nizam's Institute of Medical Sciences Hyderabad",{"name":75,"affiliation":76,"role":34},"Dr Raghavendra Gumashta","Peoples university Bhopal",{"name":78,"affiliation":79,"role":34},"Dr Tapan Kumar Saikia","Prince Aly Khan Hospital Mumbai",{"name":81,"affiliation":82,"role":34},"Dr Savita Verma","Pt BO Sharma,PGIMS\u002FUHS. Rohtak, Haryana",{"name":84,"affiliation":85,"role":34},"Dr Manish Multani","Rahate Surgical Hospital ,Nagpur",{"name":87,"affiliation":88,"role":34},"Dr Sagar Vivek Redkar","Redkar Hospital and Research Centre Goa",{"name":90,"affiliation":91,"role":34},"Dr Meghana Murthy","Vagus Super speciality hospital,Bangalore",{"name":93,"affiliation":94,"role":34},"Dr Akshata","Vydehi Institute of Medical Sciences and Research Centre,Bangalore",{"name":96,"affiliation":97,"role":34},"Dr T S Selvavinayagam","Directorate of Public Health and Preventive Medicine,Chennai",{"name":99,"affiliation":100,"role":34},"Dr Suman Kanungo","ICMR-National Institute of Cholera and Enteric Diseases,West Bengal",{"name":102,"affiliation":103,"role":34},"Dr Mohammad Shameem","Aligarh Muslim University,Uttar Pradesh",{"name":105,"affiliation":106,"role":34},"Dr Parul Bhatt","Gmers Medical College and Civil Hospital,Ahmedabad",[108],{"facility":109,"status":26,"city":110,"state":111,"zip":112,"country":113,"countryCode":114,"cosmosGeoPoint":115,"geoPoint":120,"contacts":26},"Pt BD SHARMA,PGIMS\u002FUHS","Rohtak","Haryana","124001","India","IN",{"type":116,"coordinates":117},"Point",[118,119],76.58917,28.89447,{"lat":119,"lon":118},{"type":122,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[124,127],{"name":125,"class":126},"Indian Council of Medical Research","OTHER_GOV",{"name":128,"class":6},"IQVIA Pty Ltd","100411740","phase-3-an-efficacy-and-safety-clinical-trial-of-an-investigational-covid-19-vaccine-bbv152-in-adult-volunteers-100411740",false,"NCT04641481","An Efficacy and Safety Clinical Trial of an Investigational COVID-19 Vaccine (BBV152) in Adult Volunteers","An Event-Driven, Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate Efficacy, Safety, Immunogenicity, Lot-to-Lot Consistency of BBV152, a Whole-Virion Inactivated SARS-CoV-2 Vaccine in Adults≥18 Yrs of Age","Inclusion Criteria:\n\n* Ability to provide written informed consent and availability to fulfill the study requirements.\n* Participants of either gender of aged 18 years and above.\n* Participants with good general health as determined by the discretion of the investigator, or participants with stable medical conditions. A stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization or worsening disease during the 3 months before enrolment.\n* For a female participant of child-bearing potential, planning to avoid becoming pregnant (use of an effective method of contraception or abstinence) from the time of study enrolment until at least eight weeks after the last vaccination.\n* Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner and to refrain from sperm donation from first vaccination until at least 3 months after the last vaccination.\n* Agrees not to participate in another clinical trial at any time during the study period.\n* Agrees not to take any COVID-19 licensed vaccination for the entire duration of the study.\n* Agrees to remain in the study area for the entire duration of the study.\n* Willing to allow storage and future use of biological samples for future research\n\nExclusion Criteria:\n\n* History of any other COVID-19 investigational or licensed vaccination.\n* Known history of SARS-CoV-2 infection, as declared by the subject.\n* For women, positive urine pregnancy test before the first dose of vaccination, or any time during the study period.\n* Temperature \\>38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine.\n* Resident of COVID-19 infection in the same household.\n* Known case of HIV, hepatitis B, or hepatitis C infection.\n* Receipt of any licensed\u002Fexperimental vaccine within four weeks before enrolment in this study.\n* Receipt of immunoglobulin or other blood products within the three months before vaccination in this study.\n* Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.\n* Immunoglobulins, anti-cytokine antibodies, and blood products within 6 months prior to study vaccination, during, and 21 days following the last dose of vaccination.\n* Pregnancy, lactation, or willingness\u002Fintention to become pregnant during the first 6 months after enrolment.\n* Severe and\u002For uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, an endocrine disorder, and neurological illness (mild\u002Fmoderate well-controlled comorbidities are allowed)\n\nRe-Vaccination Exclusion Criteria\n\n* Pregnancy.\n* History of virologically (RT-PCR) confirmed SARS-CoV-2 infection\n* Anaphylactic reaction following administration of the investigational vaccine.",true,"ALL","18 Years","99 Years",{"count":141,"type":142},25800,"ACTUAL","INTERVENTIONAL",[145],"PHASE3","The BBV152 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of BBV152 to prevent COVID-19 for up to 1 year after the second dose of BBV152.",[148,149],"Covid19","SARS-CoV Infection","UNKNOWN","2021-03-18",{"date":153,"type":142},"2021-03-19",{"date":155,"type":142},"2020-11-16",{"date":157,"type":158},"2022-12","ESTIMATED",{"name":5,"class":6},1]