[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100409552":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":30,"centralContacts":29,"locations":34,"responsibleParty":48,"collaborators":50,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":29,"enrollmentInfo":64,"targetDuration":29,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":29,"overallStatus":73,"whyStopped":29,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Universidad Peruana Cayetano Heredia","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Investigational vaccine 1. Wuhan","EXPERIMENTAL","Inactivated SARS-CoV-2 vaccine (Vero cell); 200WU\u002Fdose for per human use, 0.5 mL\u002F dose; Intramuscular injection; Two doses: one dose\u002F21-28 days; 4000 participants per arm",[13],"Biological: Inactivated SARS CoV 2 vaccine (Vero cell) Wuhan\u002FBeijing\u002FPlacebo",{"label":15,"type":10,"description":16,"interventionNames":17},"Investigational vaccine 2. Beijing","Inactivated SARS-CoV-2 vaccine (Vero cell); 4μg\u002Fdose for per human use, 0.5 mL\u002F dose; Intramuscular injection; Two doses: one dose\u002F21-28 days; 4000 participants per arm",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Placebo\u002FAluminum Adjuvant of Inactivated SARS CoV","PLACEBO_COMPARATOR","Placebo\u002FAluminum Adjuvant of Inactivated SARS-CoV-2 vaccine; Active Ingredient: None; Virus Contents: None; Adjuvant: aluminum hydroxide; Specification: 0.5 mL\u002F dose, 0.5mL for per human use; Intramuscular injection; Two doses: one dose\u002F21-28 days; 4000 participants per arm",[13],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"BIOLOGICAL","Inactivated SARS CoV 2 vaccine (Vero cell) Wuhan\u002FBeijing\u002FPlacebo","This clinical trial is conducted in randomized, blind, placebo controlled design Total sample size is 12 000, which are randomly allocated into investigational vaccine 1, investigational vaccine 2 and placebo control group.",[9,15,19],null,[31],{"name":32,"affiliation":5,"role":33},"Coralith Garcia, MD","PRINCIPAL_INVESTIGATOR",[35],{"facility":36,"status":29,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":29},"Av. Honorio Delgado 430, Urb. Ingeniería","San Martín de Porres","Lima region","L-031","Peru","PE",{"type":43,"coordinates":44},"Point",[45,46],-77.43306,-11.10028,{"lat":46,"lon":45},{"type":49,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[51],{"name":52,"class":6},"National University of San Marcos, Peru","100409552","phase-3-efficacy-safety-and-immunogenicity-of-inactivated-sars-cov-2-vaccines-vero-cell-to-prevent-covid-19-in-healthy-adult-population-in-peru-healthy-adult-population-in-peru-100409552",false,"NCT04612972","Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru","Ensayo Clínico de Fase III, Aleatorio, Doble Ciego y Controlado Con Placebo Paralelo, Para Evaluar la Seguridad y la Eficacia Protectora de la Vacuna Inactivada Contra el SARS-CoV-2 en la Población Sana de 18 años o más, en Perú","Covid-Peru","Inclusion Criteria:\n\n* Age range: Healthy subjects aged 18 years old and above\n* By asking for medical history and physical examination, the investigator judged that the health condition is well\n* Female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test), and do not plan to become pregnant within the first 3 months after enrolment . Effective contraceptive measures have been taken within 2 weeks before inclusion and continued for at least three month s after last dose\n* During the whole follow up period of the study, be able and willing to complete the whole prescribed study plan.\n* With self ability to understand the research procedures, with informed consent, voluntarily sign an informed consent form, and be able to comply with the requirements of the clinical study protocol.\n\nExclusion Criteria:\n\n* SARS CoV 2 Infection Confirmed Cases, Suspected Cases or Asymptomatic Infection\n* SARS CoV 2 Nucleic acid test positive\n* Have a history of SARS , MERS infection (self report, on site inquiry\n* Fever (axillary temperature \\> 37.0 ℃), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before vaccination\n* Axillary body temperature \\> 37.0 ℃ before vaccination\n* Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS CoV 2 vaccine have occurred.\n* Have a history of convulsion, epilepsy, encephalopathy or mental illness or family history\n* Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.\n* Severe liver and kidney diseases, uncontrollable hypertension (systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg), diabetic complications, malignant tumors, various acute diseases or acute attack period of chronic diseases\n* Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases\n* Diseases known or suspected include severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases, and malignant tumors. - Hist ory of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease)\n* Receiving anti TB therapy\n* Patients receiving immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14\n* Live attenuated va ccine is inoculated within 1 month before this vaccination , other vaccines are inoculated within 14 days before this vaccination\n* Received blood products within 3 months before this vaccination\n* Received other research drugs within 6 months before this vacc ination\n* Investigator judged other circumstances that are not suitable for this clinical trial.",true,"ALL","18 Years",{"count":65,"type":66},12000,"ACTUAL","INTERVENTIONAL",[69],"PHASE3","This is a multicenter, randomized, double blind, parallel placebo controlled, phase 3 clinical trial to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above.",[72],"COVID-19","COMPLETED","2023-04-27",{"date":76,"type":66},"2023-05-01",{"date":78,"type":66},"2020-09-09",{"date":80,"type":66},"2023-04-03",{"name":5,"class":6},1]