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| Name | Class |
|---|---|
| China National Biotec Group Company Limited | INDUSTRY |
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Eligible participants were randomly assigned (1:1:1), using block randomization stratified, to either 3 groups. Group 1 will be immunized inactivated SARS-CoV-2 vaccine and varicella vaccine in day 0 followed by measles-mumps-rubella vaccine(MMR) in day 28.
Group 2 will be immunized varicella vaccine in day 0 followed by SARS-CoV-2 vaccine and MMR in day 28.
Group 3 will be immunized inactivated SARS-CoV-2 vaccine in day 0 followed by MMR and varicella vaccine in day 28.
Vaccines were administered 28 days apart, with blood samples taken on day 0 and day 28 before vaccination, and on day 56. Local and systemic symptoms and serious adverse events following immunzation were collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | immunized inactivated SARS-CoV-2 vaccine and varicella vaccine in day 0 followed by measles-mumps-rubella vaccine(MMR) in day 28. |
|
| Group 2 | Experimental | immunized varicella vaccine in day 0 followed by SARS-CoV-2 vaccine and MMR in day 28. |
|
| Group 3 | Active Comparator | immunized inactivated SARS-CoV-2 vaccine in day 0 followed by MMR and varicella vaccine in day 28. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccine | Biological | Subjects will be coadministered with inactivated SARS-CoV-2 vaccine and varicella vaccine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| non-inferiority of the seroconversion rate and neutralising antibody level against SARS-CoV-2 | Neutralizing antibody of SARS-CoV-2 is an index of immunogenicity | on day 28 after vaccination |
| non-inferiority of the seroconversion rate and IgG antibody level against measles, rubella, and mumps | IgG antibodies of measles, rubella, and mumps is an index of immunogenicity | on day 28 after vaccination |
| non-inferiority of the seroconversion rate and IgG antibody level against varicella | IgG antibodies of varicella is an index of immunogenicity | on day 28 after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of reported vaccine-related adverse events within 28 days of each immunization. | adverse events including local and systemic symptoms followng immunization | from 0 to 28 days after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
First dose exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhuoying Huang | Contact | 86-21-62758710 | huangzhuoying@scdc.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhuoying Huang | Shanghai Municipal Center for Disease Control and Prevention | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Municipal Center for Disease Control and Prevention | Shanghai | Shanghai Municipality | 021 | China |
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| Inactivated SARS-CoV-2 vaccine coadministered with MMR | Biological | Subjects will be coadministered with SARS-CoV-2 vaccine and MMR. |
|
| Inactivated SARS-CoV-2 vaccine administered alone | Biological | Subjects will be immunized with inactivated SARS-CoV-2 vaccine alone |
|
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D002644 | Chickenpox |
| D008457 | Measles |
| D009107 | Mumps |
| D012409 | Rubella |
| 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 |
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D018185 | Morbillivirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D019351 | Rubulavirus Infections |
| D010309 | Parotitis |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D018355 | Rubivirus Infections |
| D014036 | Togaviridae Infections |
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