This is an international multicenter clinical trial, which is planned to be conducted in several research centers in China and Pakistan. A randomized, double-blind, placebo-controlled design will be conducted to evaluate the efficacy, safety of LYB001 against COVID-19 as a booster dose in China.
3000 subjects aged 18 years and older who have completed two or three doses of SARS-CoV-2 inactivated vaccine 6-18 months will be enrolled in China. Participants are randomly assigned to LYB001 or placebo group at a ratio of 1:1 and receive one dose at day 0.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
3,000
Intramuscular injection of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 in the deltoid muscle of the upper arm at day 0. The inoculation dose is 0.5 mL.
Intramuscular injection of placebo in the deltoid muscle of the upper arm at day 0. The inoculation dose is 0.5 mL.
Bishan District People's Hospital,Chongqing
Chongqing, Chongqing Municipality, China
Shandong Provincial Center for Disease Control and Prevention
Jinan, Shandong, China
First occurrence of confirmed symptomatic COVID-19 incidence rate per person-years of follow-up
First occurrence of confirmed symptomatic COVID-19 incidence rate from 14 days after the booster dose per person-years of follow-up;
Time frame: From 14 days after the booster dose
The occurrence of adverse events
The occurrence of adverse events within 30 mins,7 days and 28 days after each vaccination
Time frame: The occurrence of adverse events within 30 mins,7 days and 28 days after each vaccination
The occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs)
The occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months after vaccination
Time frame: Day 0 to 12 months after vaccination
First occurrence of confirmed severe, critical, and fatal COVID-19 incidence per person-years of follow-up
First occurrence of confirmed severe, critical, and fatal COVID-19 incidence from 14 days after the booster dose per person-years of follow-up
Time frame: From 14 days after the booster
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.