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Also known as COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain, COVID-19 Vaccine (Vero cell), Inactivated (Omicron variant), COVID-19 Vaccine, Inactivated, COVID-19 Vaccine,Inactivated
COVID-19 Vaccine, Inactivated, Omicron Strain · 3 trials · 1 indication
Geometric mean titres (GMTs) and seroconversion rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1), induced by a booster dose of COVID-19 vaccine (Omicron variant), 28 days (Day 28) after booster vaccination among subjects with two- or three-dose COVID-19 vaccine（CZ strain） ≥6 months before
GMTs and seroconversion rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1), induced by a booster dose of Prototype COVID-19 vaccine, 28 days (Day 28) after booster vaccination among subjects with three-dose Prototype COVID-19 vaccine≥6 months before
GMTs of the neutralizing antibody to SARS-CoV-2 Prototype strain induced by two doses of Prototype COVID-19 vaccine, 28 days after vaccination in previous clinical trial serums
The GMT of neutralizing antibodies 28 days after the second vaccination.
Geometric mean of neutralization antibody titre (GMT) on Day 14 after the last booster dose against the Omicron variant in different groups
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
| Arm | Type | Description |
|---|---|---|
| Experimental group aged 18-59 years and received 2 doses of COVID-19 vaccine（CZ strain） | EXPERIMENTAL | 400 participants aged 18-59 years and received 2 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine (Omicron variant). |
| Control Group aged 18-59 years and received 2 doses of COVID-19 vaccine（CZ strain） | ACTIVE_COMPARATOR | 200 participants aged 18-59 years and received 2 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine（CZ strain）. |
| Experimental group aged 60 years and above and received 2 doses of COVID-19 vaccine（CZ strain） | EXPERIMENTAL | 100 participants aged 60 years and above and received 2 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine (Omicron variant). |
| Control Group aged 60 years and above and received 2 doses of COVID-19 vaccine（CZ strain） | ACTIVE_COMPARATOR | 50 participants aged 60 years and above and received 2 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine（CZ strain）. |
| Experimental group aged 18-59 years and received 3 doses of COVID-19 vaccine（CZ strain） | EXPERIMENTAL | 400 participants aged 18-59 years and received 3 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine (Omicron variant). |
| Control Group aged 18-59 years and received 3 doses of COVID-19 vaccine（CZ strain） | ACTIVE_COMPARATOR | 200 participants aged 18-59 years and received 3 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine（CZ strain）. |
| Experimental group aged 60 years and above and received 3 doses of COVID-19 vaccine（CZ strain） | EXPERIMENTAL | 100 participants aged 60 years and above and received 3 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine (Omicron variant). |
| Control Group aged 60 years and above and received 3 doses of COVID-19 vaccine（CZ strain） | ACTIVE_COMPARATOR | 50 participants aged 60 years and above and received 3 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine（CZ strain）. |
| Historical control group | ACTIVE_COMPARATOR | Backup serum samples will be selected from 250 healthy adult subjects aged 26-45 years who received two doses of inactivated COVID-19 vaccine(CZ strain)from clinical trial of lot-to-lot consistency of an inactivated SARS-CoV-2 Vaccine(Pro-NCOV-4001) to detect neutralizing antibodies against the CZ, Delta and Omicron strains. |
| 3-5 years old age group | EXPERIMENTAL | 500 participants aged 3-5 years will receive two doses of COVID-19 vaccine,inactivated on day 0 and day 28. |
| 6-11 years old age group | EXPERIMENTAL | 500 participants aged 6-11 years will receive two doses of COVID-19 vaccine,inactivated on day 0 and day 28. |
| 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 |
|---|---|---|
| COVID-19 Vaccine (Vero cell), Inactivated (Omicron variant) | BIOLOGICAL | The COVID-19 Vaccine (Vero cell), Inactivated (Omicron variant)was manufactured by Sinovac Research\& Development Co., Ltd.1200SOU inactivated SARS-CoV-2 Omicron strain in 0.5ml of aluminium hydroxide solution per injection. |
| COVID-19 Vaccine (Vero cell), Inactivated (CZ strain) | BIOLOGICAL | The COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd.600SU inactivated SARS-CoV-2 CZ strain virus in 0.5 mL of aluminium hydroxide solution per injection. |
| COVID-19 Vaccine,Inactivated | BIOLOGICAL | The COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd..600SU Inactivated SARS-COV-2 virus in 0·5 mL of aluminium hydroxide solution per injection |
| 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). |
Inclusion Criteria: * Healthy adults aged 18 years and above; * Subjects completed two doses of the prototype COVID-19 vaccine (CZ strain)(the interval between the first dose and the second dose was 1-2 months)or completed 3 doses of prototype COVID-19 vaccine (CZ strain)over 6 months (the interval...
COVID-19 Vaccine, Inactivated, Omicron Strain is an investigational vaccine developed by Sinovac Biotech, Ltd for prevention of COVID-19. It is an inactivated vaccine designed against the Omicron variant of SARS-CoV-2. It has been studied as a booster immunization in healthy adults aged 18 years and above, and the clinical program includes three completed trials.
COVID-19 Vaccine, Inactivated, Omicron Strain is developed by Sinovac Biotech, Ltd, which trades under the ticker SVA. Sinovac is the sponsor of the clinical trials evaluating this inactivated Omicron-strain vaccine candidate for COVID-19.
COVID-19 Vaccine, Inactivated, Omicron Strain has been evaluated in Phase 3 clinical trials, and all three of its listed trials are completed. It is an investigational vaccine candidate and is not described as approved. The program includes one Phase 2 trial and two Phase 3 trials, with no trials currently active.
Three completed trials have evaluated this vaccine. NCT05381350 was a Phase 3 immunogenicity and safety study of booster immunization in healthy people aged 18 years and above, enrolling 1,750 participants in China. NCT05411471 was a Phase 2 booster study with 221 participants, and NCT05137418 was a Phase 3 study in healthy people aged 3 to 11 years with 1,000 participants.
Yes. COVID-19 Vaccine, Inactivated, Omicron Strain is also known as COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain, COVID-19 Vaccine (Vero cell), Inactivated (Omicron variant), and COVID-19 Vaccine, Inactivated. These names refer to the same Sinovac inactivated COVID-19 vaccine candidate targeting the Omicron strain.
Across its three completed clinical trials, COVID-19 Vaccine, Inactivated, Omicron Strain enrolled a total of 2,971 participants. The trials were randomized, double-blind, and controlled, and all were conducted in China. Participants included healthy volunteers, with ages ranging from 3 years and above depending on the study.