Trials / Completed
CompletedNCT04992260
Efficacy, Immunogenicity and Safety of COVID-19 Vaccine , Inactivated in Children and Adolescents
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase Ⅲ Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of COVID-19 Vaccine(Vero Cell) ,Inactivated in Children and Adolescents Aged 6 Months to 17 Years
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 11,349 (actual)
- Sponsor
- Sinovac Research and Development Co., Ltd. · Industry
- Sex
- All
- Age
- 6 Months – 17 Years
- Healthy volunteers
- Accepted
Summary
This study is a global multi-center , case-driven, randomized, double-blinded, and placebo-controlled phase Ⅲ clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the efficacy of two dose of CoronaVac® against RT-PCR confirmed symptomatic COVID-19 cases in participants aged 6 months to 17 years.
Detailed description
This study is a global multi-center , case-driven, randomized, double-blinded, and placebo-controlled phase Ⅲ clinical trial in participants aged 6 months to 17 years.The purpose of this study is to evaluate the efficacy of two dose of CoronaVac® against RT-PCR confirmed symptomatic COVID-19 cases in participants aged 6 months to 17 years.The experimental vaccine and placebo were both manufactured by Sinovac Research \& Development Co., Ltd. A total of 14,000 healthy participants aged 6 months to 17 years will be enrolled, and randomly assigned into 2 groups at a ratio of 1:1 to receive 2 doses of experimental vaccine (600SU) or placebo with an interval of 28 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Inactivated COVID-19 Vaccine | 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 |
| BIOLOGICAL | Controlled vaccine | 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. |
Timeline
- Start date
- 2021-09-10
- Primary completion
- 2023-05-31
- Completion
- 2023-05-31
- First posted
- 2021-08-05
- Last updated
- 2023-10-16
Locations
38 sites across 4 countries: Chile, Malaysia, Philippines, South Africa
Source: ClinicalTrials.gov record NCT04992260. Inclusion in this directory is not an endorsement.