Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthcare Professionals with the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac – PROFISCOV: A structured summary of a study protocol for a randomised controlled trial

• Published in: Current controlled trials in cardiovascular medicine Vol. 21; no. 1; pp. 853 - 3
• Main Authors: Palacios, Ricardo, Patiño, Elizabeth González, de Oliveira Piorelli, Roberta, Conde, Monica Tilli Reis Pessoa, Batista, Ana Paula, Zeng, Gang, Xin, Qianqian, Kallas, Esper G., Flores, Jorge, Ockenhouse, Christian F., Gast, Christopher
• Format: Journal Article
• Language: English
• Published: England BioMed Central 15.10.2020; BMC
• Subjects: Adolescent; Adult; Age groups; Aged; Betacoronavirus - genetics; Betacoronavirus - immunology; Brazil - epidemiology; Case-Control Studies; Clinical trials; Coronavirus Infections - epidemiology; Coronavirus Infections - immunology; Coronavirus Infections - prevention & control; Coronavirus Infections - virology; Coronaviruses; COVID-19; COVID-19 Vaccine; COVID-19 vaccines; Data Management; Double-Blind Method; Female; Health Personnel - statistics & numerical data; Humans; Immunization; Inactivated Vaccines; Incidence; Informed Consent - ethics; Injections, Intramuscular; Letter; Male; Medical personnel; Middle Aged; Pandemics - prevention & control; Phase III Clinical Trial; Placebos - administration & dosage; Pneumonia, Viral - epidemiology; Pneumonia, Viral - immunology; Pneumonia, Viral - prevention & control; Pneumonia, Viral - virology; protocol; Randomised controlled trial; Safety; SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; Therapies, Investigational - methods; Treatment Outcome; Vaccination - methods; Vaccines - administration & dosage; Vaccines - adverse effects; Vaccines - therapeutic use; Young Adult; Brazil; COVID-19; COVID-19 Vaccine; Phase III Clinical Trial; protocol; Randomised controlled trial; Brazil; Inactivated Vaccines
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-020-04775-4

To evaluate the efficacy of two doses of the adsorbed vaccine COVID-19 (inactivated) produced by Sinovac in symptomatic individuals, with virological confirmation of COVID-19, two weeks after the completion of the two-dose vaccination regimen, aged 18 years or older who work as health professionals...