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This is a randomized, open-labeled, Phase IIb clinical trial.The purpose of this study is to evaluate the immunogenicity and safety of the booster vaccine of using one or two doses of COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain in Adults above 18 Years Old Who Have Completed Two or Three Doses of mRNA Vaccine or CoronaVac®.
This is a randomized, open-labeled, Phase IIb clinical trial of 300 participants aged 18 years and above, who have completed two or three doses of mRNA vaccine or CoronaVac® in Hong Kong for at least 90 days after the last dose. After enrollment, the participants will be assigned to 2 groups according to their previous vaccination (mRNA vaccine group and CoronaVac® group) and then each group will be randomly assigned to two study arms at a ratio of 1:1 to receive one or two booster doses of COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (1 dose Omicron Vaccine arm, mRNA vaccine group) | Experimental | 75 participants who have completed two/three doses of mRNA vaccine (prior to this study) will receive one dose COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain(1200 SOU). |
|
| Arm 2 (2 doses Omicron Vaccine arm, mRNA vaccine group) | Experimental | 75 participants who have completed two/three doses of mRNA vaccine (prior to this study) will receive two doses COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain (0,28 days)(1200 SOU). |
|
| Arm 3 (1 dose Omicron Vaccine arm, CoronaVac® group) | Experimental | 75 participants who have completed two/three doses of CoronaVac®(prior to this study) will receive one dose COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain (1200 SOU). |
|
| Arm 4 (2 doses Omicron Vaccine arm, CoronaVac® group) | Experimental | 75 participants who have completed two/three doses of CoronaVac®(prior to this study) will receive two doses COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain (0,28 days)(1200 SOU). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain | Biological | The COVID-19 vaccine (Vero cell), Inactivated, Omicron Strain was developed by Sinovac Life Science Ltd.The product is a pre-filled syringe or a vial with an extractable volume of 0.5 mL. The antigen content is 1200 SOU/0.5 mL (6 µg/0.5 mL). |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean of neutralization antibody titre (GMT) | Geometric mean of neutralization antibody titre (GMT) on Day 14 after the last booster dose against the Omicron variant in different groups | Day 14 after the last booster dose |
| Occurrence, intensity, duration, and relationship of solicited local and systemic AEs | Occurrence, intensity, duration, and relationship of solicited local and systemic AEs for 7 days following each booster dose vaccination and of unsolicited AEs for 28 days post booster vaccination | 28 days post booster vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate of neutralization antibody | Seroconversion rate of neutralization antibody against the omicron variant on Day 14 after the last booster dose in different groups | Day 14 after the last booster dose |
| Seropositivity rate of neutralization antibody |
| Measure | Description | Time Frame |
|---|---|---|
| Seropositive rate of neutralizing antibody | Seropositive rate of neutralizing antibody to SARS-CoV-2 at 90 days and 183 days after one or two doses of booster vaccination in different groups | At 90 days and 183 days after one or two doses of booster vaccination |
| GMT of neutralizing antibody |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivan HUNG Fan Ngai, Doctor | Gleneagles Hospital HongKong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gleneagles Hospital HongKong | Hong Kong | China |
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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 |
| C000722752 | mRNA-1273.214 COVID-19 vaccine |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Seropositivity rate of neutralization antibody against the omicron variant on Day 14 after the last booster dose in different groups |
| Day 14 after the last booster dose |
| Occurrence and relationship of SAEs | Occurrence and relationship of SAEs within 6 months post booster vaccination. | within 6 months post booster vaccination |
GMT of neutralizing antibody to SARS-CoV-2 at 90 days and 183 days after one or two doses of booster vaccination in different groups |
| At 90 days and 183 days after one or two doses of booster vaccination |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |