Trials / Completed
CompletedNCT04551547
Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of COVID-19
A Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅰ/Ⅱ Clinical Trial, to Evaluate the Safety and Immunogenicity of the SARS-CoV-2 Inactivated Vaccine (Vero Cell) in Healthy Population Aged 3-17 Years
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 552 (actual)
- Sponsor
- Sinovac Research and Development Co., Ltd. · Industry
- Sex
- All
- Age
- 3 Years – 17 Years
- Healthy volunteers
- Accepted
Summary
This study is a randomized, double-blinded, and placebo controlled phase 1\&2 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 safety and immunogenicity of the experimental vaccine in healthy children and adolescents aged 3-17 years
Detailed description
This study is a randomized, double-blinded, single-center, placebo-controlled phase 1\&2 clinical trial in children and adolescents aged 3-17 years. The experimental vaccine and placebo were both manufactured by Sinovac Research \& Development Co., Ltd. A total of 552 subjects will be enrolled, with 72 at phase 1, and 480 at phase 2. Subjects will be assigned to receive two doses of different dosage of experimental vaccine or placebo on the schedule of day 0,28. Subjects in Phase receive the second dose 10 months or 12 months after the second dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 | The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd., with a antigen content of 300SU/0.5ml |
| BIOLOGICAL | Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 | The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd., with a antigen content of 600SU/0.5ml |
| OTHER | Two doses of placebo at the schedule of day 0,28 | The placebo contains no active ingredient and manufactured by Sinovac Research \& Development Co., Ltd. |
Timeline
- Start date
- 2020-10-31
- Primary completion
- 2021-04-30
- Completion
- 2023-02-08
- First posted
- 2020-09-16
- Last updated
- 2023-10-02
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04551547. Inclusion in this directory is not an endorsement.