The study will be a multi-national, endpoint-driven, randomized, double-blind, placebo-controlled, adaptive study in which participating adults will be randomized 1:1 to receive 2 doses of either candidate vaccine or placebo on Day 0 and 28. A total of 28,000 healthy adults aged 18 years and older will be enrolled and followed for efficacy, safety, and immunogenicity evaluations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
28,000
2 doses of SARS-CoV-2 Vaccine (Vero Cells), Inactivated should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.
2 doses of Placebo should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.
Incidence density of symptomatic COVID-19 cases
Incidence density of symptomatic COVID-19 cases occurring from 14 days after full vaccination.
Time frame: 14 days after full vaccination
Incidence density of COVID-19 moderate cases and above
Incidence density of COVID-19 moderate cases and above occurring from 14 days after full vaccination.
Time frame: 14 days after full vaccination
Incidence density of COVID-19 severe cases and above
Incidence density of COVID-19 severe cases and above occurring from 14 days after full vaccination.
Time frame: 14 days after full vaccination
Incidence density of COVID-19 death cases and above
Incidence density of COVID-19 death cases and above occurring from 14 days after full vaccination.
Time frame: 14 days after full vaccination
Incidence density of symptomatic COVID-19 cases in different age groups
Incidence density of symptomatic COVID-19 cases occurring from 14 days after full vaccination in different age groups (18\~59 years and ≥ 60 years).
Time frame: 14 days after full vaccination
Incidence of solicited local adverse events
Incidence of solicited local adverse events occurring 0-7 days after each vaccination.
Time frame: 0-7 days after each vaccination
Incidence of solicited general adverse events
Incidence of solicited general adverse events occurring 0-7 days after each vaccination.
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Time frame: 0-7 days after each vaccination
Incidence of unsolicited adverse events
Incidence of unsolicited adverse events occurring 0-28 days after each vaccination.
Time frame: 0-28 days after each vaccination
Incidence of SAE
Incidence of SAE occurring from the 1st dose through the end of study.
Time frame: from the 1st dose through the end of study
Incidence of AESI
Incidence of AESI occurring from the 1st dose through the end of study.
Time frame: from the 1st dose through the end of study
Seroconversion rate of SARS-CoV-2 neutralizing antibody
Seroconversion rate of SARS-CoV-2 neutralizing antibody in the immunogenicity subgroup
Time frame: 28 days, 90 days, 180 days and 360 days after full vaccination
Geometric mean titer of SARS-CoV-2 neutralizing antibody
geometric mean titer of SARS-CoV-2 neutralizing antibody in the immunogenicity subgroup
Time frame: 28 days, 90 days, 180 days and 360 days after full vaccination
Geometric mean fold increase of SARS-CoV-2 neutralizing antibody
Geometric mean fold increase of SARS-CoV-2 neutralizing antibody in the immunogenicity subgroup
Time frame: 28 days, 90 days, 180 days and 360 days after full vaccination
Seroconversion rate of SARS-CoV-2 IgG binding antibody
Seroconversion rate of SARS-CoV-2 IgG binding antibody in the immunogenicity subgroup
Time frame: 28 days, 90 days, 180 days and 360 days after full vaccination
Geometric mean titer of SARS-CoV-2 IgG binding antibody
Geometric mean titer of SARS-CoV-2 IgG binding antibody in the immunogenicity subgroup
Time frame: 28 days, 90 days, 180 days and 360 days after full vaccination
Geometric mean fold increase of SARS-CoV-2 IgG binding antibody
Geometric mean fold increase of SARS-CoV-2 IgG binding antibody in the immunogenicity subgroup
Time frame: 28 days, 90 days, 180 days and 360 days after full vaccination