This phase III trial aims to assess the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine (inactivated) and lot-to-lot consistency evaluation
This trial is Randomized, observer-blind, placebo-controlled two arms parallel group, prospective intervention study Approximately 1620 subjects aged 18-59 years will be enrolled in this trial for efficacy evaluation. Subjects will be divided into 2 treatment arms that are the vaccinated group and placebo group with ratio 1:1. The vaccinated arms will be grouped into three different lot number (lot 1/lot 2/ lot 3) of SARS-CoV-2 vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,620
SARS-CoV-2 vaccine (inactivated) manufactured by Sinovac
Placebo manufactured by PT. Bio Farma
Hasan Sadikin Hospital/School of Medicine, Padjadjaran University
Bandung, West Java, Indonesia
Incidence of laboratory-confirmed COVID-19 after the second dose
Percentage of laboratory-confirmed COVID-19 cases
Time frame: 14 days to 6 months after the second dose
Incidence of suspected COVID-19 cases
Percentage of suspected COVID-19 cases
Time frame: within 14 days to 6 months after the second dose.
Incidence of laboratory-confirmed cases (severe, critical and death)
Percentage of laboratory-confirmed cases (severe, critical, death)
Time frame: within 14 days to 6 months after the second dose
Seroconversion rate anti-S antibody IgG titer (ELISA)
Percentage of subjects with four-fold increasing anti-S antibody IgG titer (ELISA) compare to baseline and between batches
Time frame: 14 days after two doses of vaccination
Seroconversion rate anti-S antibody IgG titer (ELISA)
Percentage of subjects with four-fold increasing anti-S antibody IgG titer (ELISA) compare to baseline and between batches
Time frame: 6 months after two doses of vaccination
Seropositive rate of neutralizing antibodies
Percentage of subjects with four-fold increasing serum neutralizing antibody compared to baseline and between batches
Time frame: 14 days after two doses of vaccination
Seropositive rate of neutralizing antibodies
Percentage of subjects with four-fold increasing serum neutralizing antibody compared to baseline and between batches
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Time frame: 6 months after two doses of vaccination