The inactivated Booster Phase 3 study aims to determine the efficacy, safety, and immunogenicity of inactivated COVID-19 vaccines in subjects with a minimum of 90 days and a maximum of 270 days after the second dose of CoronaVac vaccine.
The inactivated Booster Phase 3 study aims to determine the efficacy, safety, and immunogenicity of inactivated COVID-19 vaccines in subjects with a minimum of 90 days and a maximum of 270 days after the second dose of CoronaVac vaccine. For the booster dose, subjects will be assigned open-label according to their preference for 2 different arms. The booster dose vaccine arms are as follows: * CoronaVac * Turkovac
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
4,340
One dose vaccine will be administered to subjects who have passed at least 90 days and at most 270 days after the second dose of the first course of CoronaVac vaccine.
One dose vaccine will be administered to subjects who have passed at least 90 days and at most 270 days after the second dose of the first course of CoronaVac vaccine.
Protection rates of Turkovac and CoronaVac vaccines against symptomatic COVID-19
Protection rates of Turkovac and CoronaVac vaccines against symptomatic COVID-19 confirmed by RT-PCR at least 14 days after booster vaccination dose.
Time frame: At least 14 days after booster vaccination dose
To Evaluate the SARS-CoV2 anti-spike protein immunoglobulin G
The change in the amount of SARS-CoV2 anti-spike protein immunoglobulin G in the 28th day compared to the baseline is 2 times or more
Time frame: 28 days after booster vaccination dose
Evaluation of SARS-CoV2 Neutralizing Antibodies
The change in the amount of SARS-CoV2 neutralizing antibodies in the 28th day compared to the baseline is 2 times or more
Time frame: 28 days after booster vaccination dose
T-Cell Evaluation
IL-2, TNF-alpha and IFN-gamma levels in T cells changed by 2 times or more on day 28 compared to baseline for 35 - 40 subjects
Time frame: 28 days after booster vaccination dose
Incidence of Adverse Events (AE)
To evaluate the safety of booster dose vaccines by determining the incidence of adverse reactions.
Time frame: On days 7 and 14 days after vaccination
Incidence of Serious Adverse Events (SAE)
To evaluate the safety of booster dose vaccines by determining the incidence of serious adverse reactions.
Time frame: 168 days after vaccination
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T.R. Ministry of Health Ankara Keçiören Sanatorium Ataturk Chest Diseases and Thoracic Surgery Training and Research Hospital
Ankara, Turkey Region, Turkey (Türkiye)
Çukurova University Faculty of Medicine, Department of Infectious Diseases
Adana, Turkey (Türkiye)
T.R. Ministry of Health Ankara City Hospital, Infectious Diseases and Clinical Microbiology Clinic
Ankara, Turkey (Türkiye)
Dışkapı SUAM Infectious Diseases and Clinical Microbiology
Ankara, Turkey (Türkiye)
T.R. Ministry of Health Antalya Training And Research Hospital
Antalya, Turkey (Türkiye)
T.R. Ministry of Health Aydın State Hospital
Aydin, Turkey (Türkiye)
T.R. Ministry of Health Balıkesir Atatürk City Hospital
Balıkesir, Turkey (Türkiye)
T.R. Ministry of Health Abant Izzet Baysal University Training and Research Hospital
Bolu, Turkey (Türkiye)
T.R. Ministry of Health Bursa City Hospital
Bursa, Turkey (Türkiye)
Uludağ University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Bursa, Turkey (Türkiye)
...and 31 more locations