This is a open label clinical trial to evaluate the efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines (Vero cell) in healthy people aged 3-17 years old in comparison with healthy population aged 18 years old and above
This is a open label clinical trial to evaluate the efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines (Vero cell) developed by Beijing Institute of Biological Products Co., Ltd in healthy people aged 3-17 years old in comparison with healthy population aged 18 years old and above. Total of 1800 healthy volunteers aged 3 years old and above will be enrolled, of whom the subjects will be divided into two groups, 3-17 years old group and 18 years old and above group with each consisting of 900 volunteers. The 3-17 years old group was further divided into three subgroups: 3-6 years old, 7-12 years old and 13-17 years old, with 300 volunteers in each subgroup. 2 doses of vaccines will be injected into the deltoid muscle of either upper arm according to the immunization schedule of D0, D21 (+7 Days). Based on interim analysis'results of the booster dose administered to adults aged 18 years old and above, a booster dose might be introduced.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,800
0.5 mL per dose, containing 6.5U inactivated SARS-CoV-2 antigen
Sheikh Khalifa Medical City, SEHA
Abu Dhabi, United Arab Emirates
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
≥4 fold increase from baseline
Time frame: 28 days after 2 dose of immunization
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Neutralizing antibody assay will be performed using the Microcytopathic assay
Time frame: 28 days after 2 dose of immunization
Safety index-Incidence of adverse reactions
the adverse event at injection site and systemic adverse event and other adverse events of the subjects are actively followed up and recorded in the subject diary card or follow-up calls
Time frame: From the beginning of the vaccination to 28 days after the full course immunization
Safety index-Incidence of serious adverse events
All SAEs will be collected
Time frame: From the beginning of the vaccination to 6 months after the full course immunization
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
≥4 fold increase from baseline
Time frame: 28 days after booster dose of immunization
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Neutralizing antibody assay will be performed using the Microcytopathic assay
Time frame: 28 days after booster dose of immunization
The distribution of neutralizing antibody titer
The proportions of neutralizing antibody titer
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Time frame: 28 days after 2 dose of immunization and booster dose