This is a randomized, open-labeled, Phase IIb clinical trial.The purpose of this study is to evaluate the immunogenicity and safety of the booster vaccine of using one or two doses of COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain in Adults above 18 Years Old Who Have Completed Two or Three Doses of mRNA Vaccine or CoronaVac®.
This is a randomized, open-labeled, Phase IIb clinical trial of 300 participants aged 18 years and above, who have completed two or three doses of mRNA vaccine or CoronaVac® in Hong Kong for at least 90 days after the last dose. After enrollment, the participants will be assigned to 2 groups according to their previous vaccination (mRNA vaccine group and CoronaVac® group) and then each group will be randomly assigned to two study arms at a ratio of 1:1 to receive one or two booster doses of COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
221
The COVID-19 vaccine (Vero cell), Inactivated, Omicron Strain was developed by Sinovac Life Science Ltd.The product is a pre-filled syringe or a vial with an extractable volume of 0.5 mL. The antigen content is 1200 SOU/0.5 mL (6 µg/0.5 mL).
Gleneagles Hospital HongKong
Hong Kong, China
Geometric mean of neutralization antibody titre (GMT)
Geometric mean of neutralization antibody titre (GMT) on Day 14 after the last booster dose against the Omicron variant in different groups
Time frame: Day 14 after the last booster dose
Occurrence, intensity, duration, and relationship of solicited local and systemic AEs
Occurrence, intensity, duration, and relationship of solicited local and systemic AEs for 7 days following each booster dose vaccination and of unsolicited AEs for 28 days post booster vaccination
Time frame: 28 days post booster vaccination
Seroconversion rate of neutralization antibody
Seroconversion rate of neutralization antibody against the omicron variant on Day 14 after the last booster dose in different groups
Time frame: Day 14 after the last booster dose
Seropositivity rate of neutralization antibody
Seropositivity rate of neutralization antibody against the omicron variant on Day 14 after the last booster dose in different groups
Time frame: Day 14 after the last booster dose
Occurrence and relationship of SAEs
Occurrence and relationship of SAEs within 6 months post booster vaccination.
Time frame: within 6 months post booster vaccination
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