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This study is a randomized, double-blinded clinical Trial, to evaluate the non-inferiority of the commercial scale Inactivated SARS-CoV-2 vaccine against that of the pilot scale among adults aged 26-45 years, and the open-labelled, bridging non-inferiority of the vaccine induced immunogenicity in elderly against that in adults.
This study is a randomized, double-blinded clinical Trial, to evaluate the non-inferiority of the commercial scale Inactivated SARS-CoV-2 vaccine against that of the pilot scale among adults aged 26-45 years, and the open-labelled, bridging non-inferiority of the vaccine induced immunogenicity in elderly against that in adults. The experimental vaccine was manufactured by Sinovac Research & Development Co.,Ltd. Totally 1040 subjects,including: 130 subjects aged 18~25 years; 520 subjects aged 26~45 years, with 260 in each group; 130 subjects aged 46~59 years; 260 subjects aged ≥60 years.
Subjects will be assigned to receive two doses of medium-dosage vaccine on the schedule of 0,14.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aged 26-45, Commercial Scale | Experimental | Commercial scale inactivated SARS-CoV-2 vaccine in adults aged 26-45 years. |
|
| Aged 18-59, Pilot Scale | Experimental | Pilot scale inactivated SARS-CoV-2 vaccine in adults aged 18-59 years. |
|
| Aged ≥60, Pilot Scale | Experimental | Pilot scale inactivated SARS-CoV-2 vaccine in elderly aged above 60 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 | Biological | The antigen content of the commercial scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group 26-45. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity index-geometric mean titer(GMT) of neutralizing antibody | Neutralizing antibody assay will be performed using the micro-neutralization method | Day 14 after the full course vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity index-Seroconversion rate of the neutralizing antibody | Neutralizing antibody assay will be performed using the micro-neutralization method. Seroconversion will be defined as a change from seronegative(<1:8) to seropositive(≥1:8), or ≥4 fold increase from baseline | Day 14 after the full course vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongxing Pan, Master | Jiangsu Provincial Center for Disease Prevention and Control | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dafeng District Center for Disease Prevention and Control | Yancheng | Jiangsu | 224100 | China |
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The first part of the study is a double-blinded trial, the second part is a open-label research.
| Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 | Biological | The antigen content of the pilot scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group 18-59. |
|
| Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderly | Biological | The antigen content of the pilot scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group above 60. |
|
| Immunogenicity index-Seropositive rate of the neutralizing antibody |
Neutralizing antibody assay will be performed using the micro-neutralization method. Subjects with a antibody titer ≥1:8 will defined as seropositive |
| Day 14 after the full course vaccination |
| Safety index-Incidence of adverse reactions | Incidence of adverse reactions from the beginning of the vaccination to 28 days after the full course vaccination | From the beginning of the vaccination to 28 days after the full course vaccination |
| Safety index-Incidence of serious adverse events | SAE will be collected throughout the clinical trial | From the beginning of the vaccination to 6 months after the full course vaccination |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000375 | Aging |
| ID | Term |
|---|---|
| D048788 | Growth and Development |
| D010829 | Physiological Phenomena |
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