This is a randomized, double-blind, active-controlled phase Ⅲ clinical trial.The purpose of this study is to evaluate the immunogenicity and safety of one booster dose of trivalent COVID-19 vaccine (vero cell), inactivated, prototype strain, delta strain and omicron strain in healthy people aged 3 years old and above and have completed two or three doses of CoronaVac® in Colombia.
This is a randomized, double-blind, and active-controlled Phase Ⅲ bridging clinical trial of 1,400 subjects aged 3 years and above and have completed two or three doses of CoronaVac at least 3 months prior to this study.After enrollment, subjects will be randomly assigned into 2 groups at a ratio of 1:1 to receive one dose of trivalent COVID-19 vaccine or CoronaVac®.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,400
The Trivalent COVID-19 Vaccine (Vero Cell), Inactivated, Prototype Strain, Delta Strain and Omicron Strain was developed by Sinovac Life Science Ltd. The antigen content of trivalent COVID-19 vaccine is a total of 18μg/0.5 ml, including 1200 SU/6 µg/0.5 ml for Prototype strain, 1200 SDU/6 µg/0.5 ml for Delta strain, and 1200 SOU/6 µg/0.5 ml for Omicron strain. The routine of administration is Intramuscular injection into deltoid region.
The COVID-19 Vaccine (Vero Cell),Inactivated was manufactured by Sinovac Life Science Ltd.The antigen content of the active-controlled vaccine (CoronaVac) is 600 SU/3 µg/0.5 ml.The routine of administration is Intramuscular injection into deltoid region.
Clinica de la Costa
Barranquilla, Colombia
Geometric Mean Titer (GMT) of the neutralizing antibody to SARS-CoV-2 Delta strain and Omicron strain
Geometric Mean Titer (GMT) of the neutralizing antibody to SARS-CoV-2 Delta strain and Omicron strain at 14 days after one booster dose of trivalent COVID-19 vaccine or CoronaVac
Time frame: At 14 days after one booster dose
Seroconversion rate of the neutralizing antibody to SARS-CoV-2 Delta strain and Omicron strain
Seroconversion rate of the neutralizing antibody to SARS-CoV-2 Delta strain and Omicron strain at 14 days after one booster dose of trivalent COVID-19 vaccine or CoronaVac
Time frame: At 14 days after one booster dose
GMT of the neutralizing antibody to SARS-CoV-2 Prototype strain
GMT of the neutralizing antibody to SARS-CoV-2 Prototype strain at 14 days after one booster dose of trivalent COVID-19 vaccine or CoronaVac.
Time frame: At 14 days after one booster dose
Seroconversion rate of the neutralizing antibody to SARS-CoV-2 Prototype strain
Seroconversion rate of the neutralizing antibody to SARS-CoV-2 Prototype strain at 14 days after one booster dose of trivalent COVID-19 vaccine or CoronaVac.
Time frame: At 14 days after one booster dose
Seropositive rate of the neutralizing antibody to SARS-CoV-2 Delta strain and Omicron strain
Seropositive rate of the neutralizing antibody to SARS-CoV-2 Delta strain and Omicron strain at 14 days after one booster dose of trivalent COVID-19 vaccine or CoronaVac.
Time frame: At 14 days after one booster dose
Geometric Mean Fold Rise (GMFR) of the neutralizing antibody to SARS-CoV-2 Delta strain and Omicron strain
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Geometric Mean Fold Rise (GMFR) of the neutralizing antibody to SARS-CoV-2 Delta strain and Omicron strain at 14 days after one booster dose of trivalent COVID-19 vaccine or CoronaVac
Time frame: At 14 days after one booster dose
Seropositive rate of the neutralizing antibody to SARS-CoV-2 Prototype strain
Seropositive rate of the neutralizing antibody to SARS-CoV-2 Prototype strain at 14 days after one booster dose of trivalent COVID-19 vaccine or CoronaVac
Time frame: At 14 days after one booster dose
GMFR of the neutralizing antibody to SARS-CoV-2 Prototype strain
GMFR of the neutralizing antibody to SARS-CoV-2 Prototype strain at 14 days after one booster dose of trivalent COVID-19 vaccine or CoronaVac.
Time frame: At 14 days after one booster dose
Occurrence, intensity, duration, and relationship of solicited local and systemic Adverse Reactions (ARs)
Occurrence, intensity, duration, and relationship of solicited local and systemic Adverse Reactions (ARs) within 7 days after booster vaccination.
Time frame: Within 7 days after booster vaccination
Occurrence, intensity, duration, and relationship of unsolicited ARs
Occurrence, intensity, duration, and relationship of unsolicited ARs within 28 days after booster vaccination.
Time frame: within 28 days after booster vaccination
Occurrence and relationship of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
Occurrence and relationship of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) within 6 months after booster vaccination.
Time frame: Within 6 months after booster vaccination