Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a double-blind, randomized phase â…£ 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 COVID-19 vaccine between the commercialized scale in workshop 2 and 3 and the commercialized scale in workshop 1 in healthy children aged 3-17 years.
This study is a double-blind, randomized phase â…£ clinical trial in healthy children aged 3-17 years to evaluate the lot-to-lot consistency, immunogenicity and safety of the commercial-scale CoronaVac in healthy children aged 3-17 years .The experimental vaccine was manufactured by Sinovac Research & Development Co.,Ltd. A total of 2520 healthy subjects aged 3 to 17 years old will be enrolled.The subjects will be randomly divided into 7 groups of 360 participants per group with an equal probability to received 7 batches of commercial-scale vaccine.All subjects received two doses of vaccine on day 0 and day 28.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 2 | Experimental | 360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 2 according to 0,28-day immunization schedule. |
|
| Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 2 | Experimental | 360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 2 according to 0,28-day immunization schedule. |
|
| Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 2 | Experimental | 360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 2 according to 0,28-day immunization schedule. |
|
| Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 3 | Experimental | 360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 3 according to 0,28-day immunization schedule. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 2 | Biological | 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 | Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine | 28 days after the full immunization |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2 | Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine | 28 days after the full immunization |
| Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Weijun Hu, Master | Shanxi Provincial Center for Disease Prevention and Control | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yaliang county Center for Disease Control and Prevention | Xi’an | Shanxi | 710054 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 3 | Experimental | 360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 3 according to 0,28-day immunization schedule. |
|
| Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 3 | Experimental | 360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 3 according to 0,28-day immunization schedule. |
|
| Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 1 | Active Comparator | 360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 1 according to 0,28-day immunization schedule. |
|
|
| Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 2 | Biological | 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection |
|
|
| Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 2 | Biological | 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection |
|
|
| Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 3 | Biological | 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection |
|
|
| Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 3 | Biological | 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection |
|
|
| Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 3 | Biological | 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection |
|
|
| Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 1 | Biological | 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection |
|
|
Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine |
| 28 days after the full immunization |
| Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 | Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine | 28 days after the full immunization |
| Incidence of adverse reactions 0-7 days after vaccination | The incidence of adverse reactions of each lot of COVID-19 vaccine 0-7 days after vaccination | 0-7 days after vaccination |
| Incidence of adverse reactions 0-28 days after vaccination | The incidence of adverse reactions of each lot of COVID-19 vaccine 0-28 days after vaccination | 0-28 days after 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000706269 | SARS-CoV-2 inactivated vaccines |
| C000722216 | sinovac COVID-19 vaccine |
Not provided
Not provided
Not provided