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| Name | Class |
|---|---|
| Beijing Minhai Biotechnology Co., Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| candidate vaccine | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 Vaccine (Vero Cells), Inactivated | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence density of symptomatic COVID-19 cases | Incidence density of symptomatic COVID-19 cases occurring from 14 days after full vaccination. | 14 days after full vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days after full vaccination |
| Incidence density of COVID-19 severe cases and above |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guifan Li, M.S | Contact | +861059613591 | liguifan@biominhai.com |
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| Placebo | Biological | 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 COVID-19 severe cases and above occurring from 14 days after full vaccination.
| 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. | 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). | 14 days after full vaccination |
| Incidence of solicited local adverse events | Incidence of solicited local adverse events occurring 0-7 days after each vaccination. | 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. | 0-7 days after each vaccination |
| Incidence of unsolicited adverse events | Incidence of unsolicited adverse events occurring 0-28 days after each vaccination. | 0-28 days after each vaccination |
| Incidence of SAE | Incidence of SAE occurring from the 1st dose through the end of study. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 28 days, 90 days, 180 days and 360 days after full 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 |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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