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CoronaVac · 1 trial · 2 indications
Differences in the humoral immunogenicity (GMT ratio \>1) of the neutralizing antibodies against the Delta and Omicron variants in response to a booster dose of the trivalent vaccine compared to CoronaVac® in adults who have initially received two doses of CoronaVac® and two booster doses with vaccines against SARS-CoV-2 different from CoronaVac® (mRNA or viral vectors (heterologous group)) will be evaluated.
Differences in the humoral immunogenicity (GMT ratio \>1) of the neutralizing antibodies against the Omicron variant generated in response to a booster dose with the Omicron vaccine when compared with CoronaVac® in adults who have initially received two doses of CoronaVac® and two booster doses with vaccines against SARS-CoV-2 different from CoronaVac® (mRNA or viral vectors (heterologous group)) will be evaluated.
Evaluation of the non-inferiority (seroconversion rate ≥5%) of neutralizing antibodies against the Omicron and Delta variants generated by a booster dose of trivalent vaccine when compared to CoronaVac® in adults who have initially received two doses of CoronaVac® and two booster doses with vaccines from other platforms (mRNA or viral vectors (heterologous group)).
Evaluation of the non-inferiority (seroconversion rate ≥5%) of neutralizing antibodies against the Omicron variant generated by a booster dose with Omicron vaccine when compared with CoronaVac® in adults who have two doses of CoronaVac® and two booster doses with vaccines from other platforms (mRNA or viral vectors (heterologous group)).
| Arm | Type | Description |
|---|---|---|
| Heterologous group receiving CoronaVac® | ACTIVE_COMPARATOR | General population that received two doses of CoronaVac® as a primary schedule of vaccination and two booster doses as part of the national vaccination schedule with mRNA or viral vector-based vaccines; and who receive a booster dose of CoronaVac® |
| Heterologous group receiving Omicron vaccine | EXPERIMENTAL | General population that received two doses of CoronaVac® as a primary schedule of vaccination and two booster doses as part of the national vaccination schedule with mRNA or viral vector-based vaccines; and who receive a booster dose of Omicron vaccine |
| Heterologous group receiving a trivalent vaccine | EXPERIMENTAL | General population that received two doses of CoronaVac® as a primary schedule of vaccination and two booster doses as part of the national vaccination schedule with mRNA or viral vector-based vaccines; and who receive a booster dose of trivalent vaccine |
| Homologous group receiving Omicron vaccine | EXPERIMENTAL | Participants of the CoronaVac03CL study who have received the primary regimen and two booster doses with CoronaVac® vaccine; and who receive a booster dose of Omicron vaccine |
| Homologous group receiving a trivalent vaccine | EXPERIMENTAL | Participants of the CoronaVac03CL study who have received the primary regimen and two booster doses with CoronaVac® vaccine and who receive a booster dose of trivalent vaccine |
| Name | Type | Description |
|---|---|---|
| CoronaVac® | BIOLOGICAL | The active ingredient is the SARS-CoV-2 virus (CZ02 strain, ancestral) grown in Vero cells and inactivated, in aluminum hydroxide. The vaccine is preservative-free, and it is packed in pre-load syringes (0.5 mL) with 600 SU/0.5mL of inactivated SARS-CoV-2. |
| Omicron Vaccine | BIOLOGICAL | An experimental intervention consisting of a booster dose of an inactivated Omicron variant vaccine. The active ingredient is the SARS-CoV-2 virus (Omicron variant) grown in Vero cells and inactivated, in aluminum hydroxide. The vaccine is preservative-free, packed in a pre-load syringe, and contains one dose (0.5mL) of 1200 SU of inactivated SARS-CoV-2 Omicron variant. |
| Trivalent Vaccine | BIOLOGICAL | An experimental intervention consisting of a booster dose of an inactivated trivalent (CZ02 strain, ancestral, Delta, and Omicron variants) variant vaccine. The active ingredient is the SARS-CoV-2 virus (CZ02 strain, ancestral, Delta, and Omicron variants) grown in Vero cells and inactivated, in aluminum hydroxide. The vaccine is preservative-free, and it is packed in a pre-load syringe containing one dose (0.5mL) (1200 SU of inactivated SARS-CoV-2 WT, 1200 SU of inactivated SARS-CoV-2 Delta variant, and 1200 SU of inactivated SARS-CoV-2 Omicron variant). |
Inclusion Criteria: * Adults, male or female, over 18 years of age; * Fully vaccinated against SARS-CoV-2 with two initial doses of CoronaVac® vaccine and that have received two booster doses of a different vaccine (heterologous group) or with CoronaVac® (homologous group) at least 5 months before ...
CoronaVac is an investigational vaccine being studied for the prevention of COVID-19. It is currently in Phase 2 clinical development. The vaccine is being evaluated in adults aged 18 years and older.
CoronaVac is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company. The company's stock is listed under the ticker symbol SVA.
CoronaVac is currently in Phase 2 clinical development. It is an investigational vaccine and has not been approved for use. One Phase 2 clinical trial has been completed.
CoronaVac has been studied in a completed Phase 2 clinical trial with the identifier NCT05593042. This trial evaluated the immunogenicity of an Omicron variant-based vaccine and a trivalent vaccine in adults against COVID-19 in Chile.
CoronaVac is being studied in a clinical trial that evaluates an Omicron variant-based vaccine and a trivalent vaccine. The trial is designed to assess the immunogenicity of these vaccine formulations in adults against COVID-19.