Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0, 28 · 2 trials · 1 indication
Incidence of adverse reactions after each dose vaccination.
Neutralizing antibody assay will be performed using the micro-neutralization method. Seroconversion will be defined as a change from seronegative (\<1:8) to seropositive (≥1:8), or ≥4 fold increase from baseline.
| Arm | Type | Description |
|---|---|---|
| Experimental Vaccine-low dosage | EXPERIMENTAL | low dosage inactivated SARS-CoV-2 vaccine |
| Experimental Vaccine-medium dosage | EXPERIMENTAL | medium dosage inactivated SARS-CoV-2 vaccine |
| Placebo | PLACEBO_COMPARATOR | No active ingredient in the placebo |
| Experimental Vaccine-high dosage | EXPERIMENTAL | 24 participants in high-dosage group in phase Ⅰ will receive two doses of primary immunization according to the immunization schedule of day 0, 28 and will receive 1 dose of booster immunization 1 year after primary immunization; 100 participants in high-dosage group in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 ,1 dose of booster immunization 6 months after primary immunization(the third dose) and the second booster dose (fourth dose) 1 year after the second dose . |
| Name | Type | Description |
|---|---|---|
| Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 | BIOLOGICAL | The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd., with a antigen content of 300SU/0.5ml |
| Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 | BIOLOGICAL | The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd., with a antigen content of 600SU/0.5ml |
| Two doses of placebo at the schedule of day 0,28 | OTHER | The placebo contains no active ingredient and manufactured by Sinovac Research \& Development Co., Ltd. |
| Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 | BIOLOGICAL | The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd..Two doses of high dosage (1200SU/0.5ml) experimental vaccine at the schedule of day 0,28,and one dose of booster immunization(the third dose) with medium dosage (1200SU/0.5ml) experimental vaccine 1 year after primary immunization at the schedule of day 0,28 in phaseⅠand 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.And the second booster dose (the fourth dose) 1 year after the second dose. |
Inclusion Criteria: * Healthy children and adolescents aged 3-17 years; * The subject and/or guardian can understand and voluntarily sign the informed consent form (double sign required for 8-17 years old); * Proven legal identity. Exclusion Criteria: * Travel history / residence history of commu...
Top 9 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE3 | BNT162b2 |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Molnupiravir |
| Invivyd, Inc. | IVVD | 2 | PHASE3 | VYD2311 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Tradipitant |
| BioVie Inc. Class A | BIVI | 1 | PHASE2 | NE3107 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Traws Pharma, Inc. | TRAW | 1 | PHASE2 | Ratutrelvir |
| GeoVax Labs, Inc. | GOVX | 1 | PHASE2 | GEO-CM04S1 |
It is an investigational inactivated vaccine candidate developed by Sinovac Biotech, Ltd for the prevention of COVID-19. The regimen uses a medium dosage given as two doses on a day 0 and day 28 schedule. It is a vaccine modality studied in Phase 1 clinical trials.
It is being studied for the prevention of COVID-19, the disease caused by SARS-CoV-2 infection. The trials enrolled healthy volunteers, including adults aged 60 years and older and children as young as 3 years, to assess safety and immune response.
Sinovac Biotech, Ltd is the developer of this inactivated SARS-CoV-2 vaccine candidate. The company trades under the ticker SVA. Sinovac conducted the Phase 1 trials of this regimen in China.
It is in Phase 1 clinical development. Two Phase 1 trials have been completed, with no active trials ongoing. The candidate is investigational and has not been established as an approved product based on the available development information.
It was evaluated in two completed Phase 1 trials: NCT04551547, which enrolled 552 participants aged 3 years and older, and NCT04383574, which enrolled 422 participants aged 60 years and older. Both were randomized, double-blind, placebo-controlled studies conducted in China.