Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CoronaVac
SARS-CoV-2 Inactivated Vaccine · 2 trials · 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)).
Incidence rate of adverse reactions occured from the beginning of the vaccination to 28 days after the second dose.
| 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 |
| Experimental Group | EXPERIMENTAL | Participant will receive two doses of medium dosage inactivated SARS-CoV-2 vaccine . Vaccine will given by intramuscular injection on day 0 and day 28. |
| Control Group | PLACEBO_COMPARATOR | Placebo will receive two doses of placebo. The placebo will given by intramuscular injection on day 0 and day 28. |
| 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). |
| SARS-CoV-2 Inactivated Vaccine | BIOLOGICAL | 600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection |
| Placebo | BIOLOGICAL | aluminium hydroxide solution only |
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 ...
Top 9 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Molnupiravir |
| Invivyd, Inc. | IVVD | 2 | PHASE3 | VYD2311 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Tradipitant |
| Moderna, Inc. | MRNA | 2 | PHASE2 | mRNA-1283, mRNA-1273 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Traws Pharma, Inc. | TRAW | 1 | PHASE2 | Ratutrelvir |
| GeoVax Labs, Inc. | GOVX | 1 | PHASE2 | GEO-CM04S1 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE2 | Remdesivir |
The SARS-CoV-2 inactivated vaccine developed by Sinovac Biotech is intended for the prevention of COVID-19. It is being studied in children and adolescents, with a Phase 2 trial conducted in China in healthy volunteers aged 3 years and older. It is an inactivated vaccine candidate for COVID-19.
Sinovac Biotech, Ltd is developing the SARS-CoV-2 inactivated vaccine. The company trades under the ticker SVA. The vaccine candidate is being evaluated for COVID-19 prevention, with a completed Phase 2 trial in children and adolescents conducted in China.
The SARS-CoV-2 inactivated vaccine is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The completed study was a randomized, double-blind, placebo-controlled trial of 500 healthy volunteers aged 3 years and older in China.
The SARS-CoV-2 inactivated vaccine has been studied in one clinical trial, NCT04884685, titled Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac) in Children and Adolescents. That Phase 2 trial was completed, enrolled 500 participants in China, and used a randomized, double-blind, placebo-controlled design.
Yes, the SARS-CoV-2 inactivated vaccine developed by Sinovac Biotech is also known as CoronaVac. The Phase 2 trial NCT04884685, which evaluated safety in children and adolescents, refers to the vaccine as CoronaVac. CoronaVac is the name used for this inactivated COVID-19 vaccine candidate.