This is a multicenter, randomized, double blind, parallel placebo controlled, phase 3 clinical trial to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above.
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above. The participants were randomized into three groups of investigational vaccine 1, investigational vaccine 2 and placebo in a 1:1:1 ratio.2 doses of the investigational vaccine or placebo are inoculated into the deltoid muscle of the either arm according to the vaccination schedule of D0 \& D21 (+7 days).According to the immune durability results in Phase I/II study, and cross-neutralization assay results, a third dose (booster dose) generates a better immune response and is estimated to offer better protection, therefore, a booster dose will be given after 3 months
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
44,101
The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP
The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by BIBP
The placebo of inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP
Bahrain International Exhibition & Convention Centre Affiliated to Salymynia Medical Complex S
Sanābis, Bahrain
Katameya Medical Center
Cairo, Egypt
Vacsera health Care facilities , MoH
Cairo, Egypt
Prince Hamza Hospital
Amman, Jordan
The incidence of COVID-19 cases after two-doses of vaccination
Time frame: From14 days after the second dose to 6 month after the second dose
The incidence of COVID-19 cases after the booster dose of immunization
Time frame: From 14 days after the booster dose
The incidence of severe cases of COVID-19 and deaths accompanied by COVID-19 after two-doses of vaccination
Time frame: From 14 day after the second dose to 6 month after the second dose
The incidence of severe cases of COVID-19 and deaths accompanied by COVID-19 after two-doses of vaccination
Time frame: From 14 day after the booster dose
The incidence of any adverse reactions/events
Time frame: 28 days after each immunization
The incidence of serious adverse events (SAE)
Time frame: From the beginning of the first dose to 12 months after the second immunization
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Time frame: 14 days after full course of immunization
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
Time frame: 14 days after full course of immunization
The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody
Time frame: 14 days after full course of immunization
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
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Sheikh Khalifa Medical City, SEHA
Abu Dhabi, United Arab Emirates
Al Qarain Primary Health Care Centre-MOHAP
Sharjah city, United Arab Emirates
Time frame: 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization
The 4-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
Time frame: 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization
The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody
Time frame: 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Time frame: 14 days, 28 days and 6th month after the booster dose
The 4-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
Time frame: 14 days, 28 days and 6th month after the booster dose
The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody
Time frame: 14 days, 28 days and 6th month after the booster dose