Trials / Unknown
UnknownNCT05238649
Immunogenicity and Safety of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine
A Randomized, Double Blind, Positive Control Clinical Study to Evaluate the Immunogenicity and Safety of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Against COVID-19 in Healthy Adults Aged 18 Years and Older After the Vaccination of 2 Doses of Inactivated Vaccines
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- Livzon Pharmaceutical Group Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
A Randomized, Double Blind, Positive Control Clinical Study to Evaluate the Immunogenicity and Safety of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Against COVID-19 in Healthy Adults Aged 18 Years and Older After the Vaccination of 2 Doses of Inactivated Vaccines
Detailed description
This is a Randomized, Double Blind, Positive Control exploratory clinical study. 150 participants aged 18 years and older who have completed the 2 doses of administration of inactive vaccines 6 months (±1 month) ago were enrolled in this study to evaluate the safety and immunogenicity of V-01. The participants will be enrolled to test group A (V-01 10 μg), test group B (V-01 25 μg) and test group C (inactivated vaccine) by the ratio of 1:1:1. The participants received 1 dose of V-01 or inactivated vaccine base on the group. The random stratification factor is age (18-59 years old vs. ≥ 60 years old).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Recombinant SARS-CoV-2 Fusion Protein Vaccine 10μg | The product should be a milky-white suspension for injection. For prevention of SARS-CoV-2 infection. |
| BIOLOGICAL | Recombinant SARS-CoV-2 Fusion Protein Vaccine 25μg | The product should be a milky-white suspension for injection. For prevention of SARS-CoV-2 infection. |
| BIOLOGICAL | SARS-Cov-2 Vaccine Inactivated | The product should be a milky-white suspension for injection. For prevention of SARS-CoV-2 infection. |
Timeline
- Start date
- 2021-11-10
- Primary completion
- 2022-11-30
- Completion
- 2023-01-28
- First posted
- 2022-02-14
- Last updated
- 2022-03-29
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05238649. Inclusion in this directory is not an endorsement.