This clinical trial is a phase I/II clinical trial to evaluate the safety, immunogenicity and immune persistence of COVID-19 mRNA vaccine in healthy people aged 18 years and above.
This is the clinical trial including an open-label, single-arm Phase I study and a subsequent randomized, blind, placebo-parallel controlled Phase II study to evaluate the safety, immunogenicity and immune persistence of COVID-19 mRNA vaccine in healthy people aged 18-60 years and ≥18 years respectively, whose locations or circumstances put them at appreciable risk of acquiring COVID-19 and/or SARS-CoV-2 infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
480
Intramuscular injection, COVID-19 mRNA vaccine/placebo, 21 days interval
Mayfong Mayxay
Vientiane, Laos
local/systemic solicited adverse reaction/events
The incidence of local/systemic solicited adverse reaction/events
Time frame: up to 6 days after each dose
unsolicited adverse events
The incidence of unsolicited adverse events
Time frame: up to 21 days and up to 28 days after the first and second dose of immunization, respectively
The incidence of SAE
The incidence of SAE from the first dose of vaccination to 28 days after the full course of immunization
Time frame: up to 28 days after the full course of immunization
The seroconversion rate, 2-fold or 4-fold rise and GMT/GMI of the SARS-COV-2 S-protein specific antibody (specific total antibody/IgG antibody) and neutralizing antibody
The seroconversion rate, 2-fold or 4-fold rise and GMT/GMI of the SARS-COV-2 S-protein specific antibody (specific total antibody/IgG antibody) and neutralizing antibody 14 days after the full immunization in the subjects who take two doses as protocol specified
Time frame: 14 days after the full immunization
The incidence of SAE
The incidence of SAE within the 29th \~365th day after the full course of immunization
Time frame: the 29th ~365th day after the full course of immunization
Changes in laboratory abnormal parameters
Changes in laboratory abnormal parameters in the participants who take at least of one dose
Time frame: after at least of one dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.