Serious Adverse Events

[키워드] 1:1 24 hour 24 hours 95% confidence interval Activation Active surveillance administration Administrative Personnel Adverse adverse event adverse events Adverse reaction Adverse reactions African green monkey age Algorithm Aluminium aluminium hydroxide anaphylaxis Antibody test Antibody titer Antigen Arm asplenia assigned assumed assumption Autoimmune baseline bleeding disorders Blinding blood product blood products blood sample Blood samples breastfeeding women breath carried Cell culture China chloride Clinical efficacy clinical trial code Cohort cohorts comparator consent form cooperation Corticosteroid Corticosteroids COVID-19 COVID-19 cases COVID-19 disease COVID-19 symptoms COVID-19 test criteria Critical CRO Data and Safety Monitoring Board Day development diary dihydrogen DIHYDROGEN PHOSPHATE disease disodium disodium hydrogen phosphate dissemination dose dose of vaccination double blind double-blind double-blind study Efficacy Efficacy and safety element eligible Endpoint enrolled enrolment ethics committee evaluate event excluded exclusion criteria expected Follow-up follow-up period Frequency Gender genders green monkey group groups healthcare Healthcare professional healthcare professionals higher risk HIV infection hospital Hospitalization hydrogen Hydrogen phosphate hydroxide hypersensitivity identity IgG level IgG levels IgG test immunogenicity Immunoglobulin immunoglobulins immunosuppressive immunosuppressive therapy inactivated Inactivated Vaccines incidence incidence rate include Inclusion individual information informed consent form initiated Interactive Web Response System intramuscular dose investigator IWRS IWRS system kidney knowledge Local local reactions management medical doctors medical emergency Ministry of Health mortality rates neutralizing antibody Neutralizing antibody titer Novel coronavirus number Nurses objective Omega Other participant PCR PCR positivity performed Phase III Clinical Trial phosphate Placebo placebo group placebo-controlled positive pregnancy test pregnant preparation primary efficacy endpoint professional proportion protocol randomised randomised controlled trial randomised placebo controlled trial randomization Randomized Randomly Reactions receive recorded regimens Registration reported response risk risk of infection RT-PCR RT-PCR test RT-PCR tests Safety Monitoring Board Sample size SARS-CoV-2 vaccine SARS-CoV-2 virus screened second dose secondary Secondary objectives Serious Adverse Event Serious Adverse Events seroconversion rate Seropositivity severity severity of COVID-19 shown Sinovac sodium Sodium chloride sodium dihydrogen phosphate Sponsor status study group Study protocol subject subject’ supplementary material Symptom symptomatic symptomatic case symptomatic cases System systemic adverse reaction the ethics committee the timing the vaccine therapy Treatment treatment arm Trial Turkey two-sided vaccinated groups vaccination Vaccine Vero Vero Cell Web website width with COVID-19 within 6 months
[DOI] 10.1186/s13063-021-05180-1 PMC 바로가기 [Article Type] Letter