Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04992260 | Efficacy, Immunogenicity and Safety of COVID-19 Vaccine , Inactivated in Children and Adolescents | PHASE3 | COMPLETED | 11,349 | — | — | Sep 10, 2021 | May 31, 2023 | Oct 16, 2023 | 38 | Chile, Malaysia +2 |
Incidence of RT-PCR confirmed symptomatic COVID-19 cases with onset at least 14 days after the second dose
| 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. |
| 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. |
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 ...