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This study is a double-blind, randomized phase Ⅳ clinical trial of the inactivated SARS-CoV-2 vaccine (CoronaVac)manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the lot-to-lot consistency, immunogenicity and safety of CoronaVac in healthy adults aged 26-45 years.
This study is a double-blind, randomized phase â…£ clinical trial in healthy adults aged 26-45 years to evaluate the lot-to-lot consistency, immunogenicity and safety of the commercial-scale CoronaVac in healthy adults aged 26-45 years .The experimental vaccine was manufactured by Sinovac Research & Development Co.,Ltd. A total of 1080 healthy subjects aged 26 to 45 years old will be enrolled.The subjects will be randomly divided into three groups in a ratio of 1:1:1 to received two doses of vaccine on day 0 and day 28.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inactivated SARS-CoV-2 vaccine Lot 1 | Experimental | Participants (n=360) aged 26-45 years will receive Inactivated SARS-CoV-2 vaccine Lot 1 according to 0,28-day immunization schedule. |
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| Inactivated SARS-CoV-2 vaccine Lot 2 | Experimental | Participants (n=360) aged 26-45 years will receive Inactivated SARS-CoV-2 vaccine Lot 2 according to 0,28-day immunization schedule. |
|
| Inactivated SARS-CoV-2 vaccine Lot 3 | Experimental | Participants (n=360) aged 26-45 years will receive Inactivated SARS-CoV-2 vaccine Lot 3 according to 0,28-day immunization schedule. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated SARS-CoV-2 Vaccine (Vero cell) | Biological | 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 in susceptible population | GMT of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population | Day 28 after the second dose |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 in total population | Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population | Day 28 after the second dose |
| Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 in total population |
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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 |
|---|---|---|---|---|---|---|
| Jingliang Wu | Huai'an | Jiangsu | 223300 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36441137 | Derived | Zhu D, Hu Y, Jiang Z, Yang T, Chu K, Zhang H, Hu J, Meng X, Tan Z, Wu J, Lian X, Li C, Pan H. Lot-to-lot consistency, immunogenicity, and safety of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults: A randomized, double-blind, phase IV trial. Hum Vaccin Immunother. 2022 Nov 30;18(6):2135929. doi: 10.1080/21645515.2022.2135929. Epub 2022 Nov 28. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000706269 | SARS-CoV-2 inactivated vaccines |
| C000722216 | sinovac COVID-19 vaccine |
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|
Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population |
| Day 28 after the second dose |
| GMT of the neutralizing antibody to live SARS-CoV-2 in total population | GMT of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population | Day 28 after the second dose |
| Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2 in total population | GMI of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population | Day 28 after the second dose |
| Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 in susceptible population | Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population | Day 28 after the second dose |
| Seropositive rate of the neutralizing antibody to live SARS-CoV-2 in susceptible population | Seropositive rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population | Day 28 after the second dose |
| GMI of the neutralizing antibody to live SARS-CoV-2 in susceptible population | GMI of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population | Day 28 after the second dose |
| Seropositivity rate of anti-SARS-CoV-2 S antibody | Seropositivity rate of the anti-SARS-CoV-2 S antibody at day 28 after the second dose | Day 28 after the second dose |
| Seroconversion rate of anti-SARS-CoV-2 S antibody | Seroconversion rate of the anti-SARS-CoV-2 S antibody at day 28 after the second dose | Day 28 after the second dose |
| Geometric mean concentration (GMC) of anti-SARS-CoV-2 S antibody | GMC of the anti-SARS-CoV-2 S antibody at day 28 after the second dose | Day 28 after the second dose |
| GMI of anti-SARS-CoV-2 S antibody | GMI of the anti-SARS-CoV-2 S antibody at day 28 after the second dose | Day 28 after the second dose |
| Incidence of adverse reactions after vaccination | Incidence of adverse reactions from the beginning of the vaccination to 28 days after the second dose | From the beginning of the vaccination to 28 days after the second dose |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |