Publication Omma A, Hum Vaccines Immunother, 2022
Dates: 2021-07-12 to 2021-09-10
Funding: Public/non profit (Health Institutes of Türkiye (TUSEB))
Conflict of interest: no COI
Multicenter / Turkiye |
Follow-up duration (months): 1
|3 mcg TURKOVAC (n = 108)
3 mcg (600 SU) CoronaVac (n = 114)
1 IM dose of 3 mcg TURKOVAC (booster), between 90-270 days after second dose of prime with CoronaVac.
1 IM dose of 3 mcg (600 SU) CoronaVac (booster), between 90-270 days after second dose of prime with CoronaVac.
|Characteristics of participants|
Type of participants: Adults
Pregnant women: 0
Immunocompromized patients: 0
Age range: NR
|Description of participants|
Adults including healthy or stable co-morbidities with no recent history of COVID-19 in 4 centres in Turkiye.
|In the register|
1) Incidence of adverse reactions [Time Frame: 7 days after vaccination]: Incidence of adverse reactions within 7 days of vaccination in all subjects. 2) Incidence of Serious Adverse Events (SAE) [Time Frame: 168 days after vaccination]: Incidence of Serious Adverse Events (SAE) in all subjects 168 days after vaccination.
|In the report|
Number, severity, and rate of volunteers experiencing AEs and serious AEs... incidence of adverse reactions within 7 days post-vaccination and the incidence of serious AEs up to day 28 post-vaccination
Yes. In English
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
|General comment||In addition to the published article, the study registry and protocol were used in data extraction and risk of bias assessment. Preliminary analysis. The trial (n = 222) achieved its target sample size (n = 222). There is no change from the trial registration in the intervention and control treatments.|