Po cepljenju umrlo več kot 20 ljudi
https://clinicaltrials.gov/ct2/show/NCT04368728
Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ]
Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ]
Per 1000 person-years of follow-up
Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ]
Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values [ Time Frame: 1 day after dose 1 ]
As measured at the central laboratory
Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values [ Time Frame: 7 days after dose 1 ]
As measured at the central laboratory
Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values [ Time Frame: 7 days after dose 2 ]
As measured at the central laboratory
Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between baseline and 1 day after dose 1 ]
As measured at the central laboratory
Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between baseline and 7 days after dose 1 ]
As measured at the central laboratory
Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between before dose 2 and 7 days after dose 2 ]
As measured at the central laboratory
Odstotek udeležencev 1. faze z nenormalnimi laboratorijskimi vrednostmi hematologije in kemije [časovni okvir: 1 dan po odmerku 1]
Izmerjeno v centralnem laboratoriju
Odstotek udeležencev 1. faze z nenormalnimi laboratorijskimi vrednostmi hematologije in kemije [časovni okvir: 7 dni po odmerku 1]
Izmerjeno v centralnem laboratoriju
Odstotek udeležencev 1. faze z nenormalnimi laboratorijskimi vrednostmi hematologije in kemije [časovni okvir: 7 dni po odmerku 2]
Izmerjeno v centralnem laboratoriju
Odstotek udeležencev 1. faze s premiki pri ocenjevanju hematoloških in kemijskih laboratorijskih ocen [Časovni okvir: med izhodiščem in 1 dnevom po odmerku 1]
Izmerjeno v centralnem laboratoriju
Odstotek udeležencev 1. faze s premiki pri ocenjevanju hematoloških in kemijskih laboratorijskih ocen [Časovni okvir: med izhodiščem in 7 dnevi po odmerku 1]
Izmerjeno v centralnem laboratoriju
Odstotek udeležencev faze 1 s premiki pri ocenjevanju hematoloških in kemijskih laboratorijskih ocen [Časovni okvir: med odmerkom 2 in 7 dnevi po odmerku 2]
Izmerjeno v centralnem laboratoriju