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It is a prospective open-labeled study, We intended to recruit the participants who completed 2 doses of inactivated COVID-19 vaccine 4-8 months before, and volunteered to receive the third dose of vaccine (inactivated vaccine, recombinant subunit protein vaccine or mRNA vaccine) into the experimental group, and the participants who completed 2 doses of inactivated COVID-19 vaccine 4-8 months before without a third dose of vaccination plan into the control group. Participants in the experimental group received the third dose of SARS-CoV-2 vaccination at baseline, and participants in the control group received no intervention. Each subject will be followed up for one year after enrollment, and neutralizing antibodies and total antibodies will be tested at the specified time points, as well as the records of adverse events and adverse reactions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Participants volunteered not to receive the third dose of vaccine, and agreed to be followed-up for 1 year | |
| Inactivated Vaccine Group | Experimental | Participants volunteered to receive the third dose of inactivated vaccine |
|
| Recombinant subunit protein vaccine | Experimental | Participants volunteered to receive the third dose of subunit protein vaccine |
|
| mRNA vaccine Group | Experimental | Participants volunteered to receive the third dose of mRNA vaccine ( To be enrolled, the vaccine has not been approved in China) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccine, COVID19 | Drug | It is a prospective open-labeled study, We intended to recruit the participants who completed 2 doses of inactivated COVID-19 vaccine 4-8 months before, and volunteered to receive the third dose of vaccine (inactivated vaccine, recombinant subunit protein vaccine or mRNA vaccine) into the experimental group, and the participants who completed 2 doses of inactivated COVID-19 vaccine 4-8 months before without a third dose of vaccination plan into the control group. Participants in the experimental group received the third dose of SARS-CoV-2 vaccination at baseline, and participants in the control group received no intervention. Each subject will be followed up for one year after enrollment, and neutralizing antibodies and total antibodies will be tested at the specified time points, as well as the records of adverse events and adverse reactions. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of Third Dose Vaccine Booster Following Two Doses of Inactivated Vaccines | Observe the 28th day of the subjects' pseudovirus neutralizing antibody geometric mean titers (GMTs) and mean geometric titers fold growth (GMFR) changes | Day 28 |
| Reactogenicity of Third Dose Vaccine Booster Following Two Doses of Inactivated Vaccines | All solicited and non-solicited adverse events within 28 days. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| The seropositive rate of neutralizing antibodies | The seropositive rate of neutralizing antibodies after third vaccination shots | 3 days/14 days/28days/45days/60 days/90 days/180 days/365 days |
| GMT of neutralizing antibodies |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital affiliated to Fudan University | Shanghai | Jingan | 200041 | China | ||
| Beijing Ditan Hospital Capital Medical University |
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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 |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
GMT of neutralizing antibodies after third vaccination shots
| 3 days/14 days/28days/45days/60 days/90 days/180 days/365 days |
| GMFR of neutralizing antibodies | GMFR of neutralizing antibodies after third vaccination shots | 3 days/14 days/28days/45days/60 days/90 days/180 days/365 days |
| severe adverse events and adverse events of special interest | severe adverse events and adverse events of special interest | up to 1 year |
| Beijing |
| China |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |