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Also known as CoronaVac
Inactivated COVID-19 Vaccine · 2 trials · 2 indications
Incidence of RT-PCR confirmed symptomatic COVID-19 cases with onset at least 14 days after the second dose
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 |
|---|---|---|
| Experimental Group | EXPERIMENTAL | subjects will receive two doses of inactivated COVID-19 vaccine on day 0 and day 28. |
| Control Group | PLACEBO_COMPARATOR | subjects will receive two doses of placebo on day 0 and day 28. |
| 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 |
|---|---|---|
| Inactivated COVID-19 Vaccine | BIOLOGICAL | The inactivated COVID-19 vaccine was manufactured by Sinovac Research\& Development Co., Ltd..600SU Inactivated SARS-COV-2 virus in 0·5 mL of aluminium hydroxide solution per injection |
| Controlled vaccine | BIOLOGICAL | The placebo was manufactured by Sinovac Research\& Development Co., Ltd.The composition is aluminium hydroxide,The appearance of the placebo is consistent with the vaccine, which is a milky-white suspension. |
| 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: * Healthy children and adolescents aged 6 months to 17 years; * The participants and/or their guardians are able to understand and sign the informed consent voluntarily (in accordance with the local regulations); * Able to comply with study procedures based on the assessment of ...
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 Inactivated COVID-19 Vaccine is an investigational vaccine developed by Sinovac Biotech, Ltd for the prevention of COVID-19. It is a vaccine modality that uses inactivated virus and is in Phase 3 clinical development. It is not described as approved.
The Inactivated COVID-19 Vaccine is being developed for the prevention of COVID-19, an infectious disease. Its clinical program has studied use in children and adolescents, with trial participants as young as 6 months of age.
The Inactivated COVID-19 Vaccine is developed by Sinovac Biotech, Ltd, which trades under the ticker SVA. Sinovac is the sponsor of the clinical program for this inactivated vaccine candidate.
The Inactivated COVID-19 Vaccine is in Phase 3 clinical development. One Phase 3 trial has been completed, and no active trials are ongoing. It is an investigational vaccine and is not described as FDA approved.
The Inactivated COVID-19 Vaccine has been studied in one completed Phase 3 trial, NCT04992260, titled Efficacy, Immunogenicity and Safety of COVID-19 Vaccine, Inactivated in Children and Adolescents. It enrolled 11,349 participants across Chile, Malaysia, the Philippines, and South Africa.
The Phase 3 trial NCT04992260 was a randomized, double-blind, placebo-controlled study of the Inactivated COVID-19 Vaccine in healthy volunteers. It enrolled 11,349 participants of all sexes, with a minimum age of 6 months, and has been completed.