Trials / Completed
CompletedNCT04617483
Study of the Commercial Scale SARS-CoV-2 Vaccine Against the Pilot Scale Among Adults, and Bridging Study of the Immunogenicity in Elderly Against That in Adults
A Randomized, Double-Blinded Clinical Trial, to Evaluate the Non-inferiority of the Commercial Scale Inactivated SARS-CoV-2 Vaccine Against That of the Pilot Scale Among Adults Aged 26-45 Years, and the Open-labelled, Bridging Non-inferiority of the Vaccine Induced Immunogenicity in Elderly Against That in Adults
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,040 (actual)
- Sponsor
- Sinovac Research and Development Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This study is a randomized, double-blinded clinical Trial, to evaluate the non-inferiority of the commercial scale Inactivated SARS-CoV-2 vaccine against that of the pilot scale among adults aged 26-45 years, and the open-labelled, bridging non-inferiority of the vaccine induced immunogenicity in elderly against that in adults.
Detailed description
This study is a randomized, double-blinded clinical Trial, to evaluate the non-inferiority of the commercial scale Inactivated SARS-CoV-2 vaccine against that of the pilot scale among adults aged 26-45 years, and the open-labelled, bridging non-inferiority of the vaccine induced immunogenicity in elderly against that in adults. The experimental vaccine was manufactured by Sinovac Research \& Development Co.,Ltd. Totally 1040 subjects，including: 130 subjects aged 18\~25 years; 520 subjects aged 26\~45 years, with 260 in each group; 130 subjects aged 46\~59 years; 260 subjects aged ≥60 years. Subjects will be assigned to receive two doses of medium-dosage vaccine on the schedule of 0,14.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 | The antigen content of the commercial scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group 26-45. |
| BIOLOGICAL | Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 | The antigen content of the pilot scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group 18-59. |
| BIOLOGICAL | Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderly | The antigen content of the pilot scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group above 60. |
Timeline
- Start date
- 2020-10-31
- Primary completion
- 2020-11-28
- Completion
- 2021-05-31
- First posted
- 2020-11-05
- Last updated
- 2021-07-27
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04617483. Inclusion in this directory is not an endorsement.