Trials / Unknown
UnknownNCT05069129
Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cells,NVSI-06-08) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above
A Randomized, Controlled Phase I and Sequential Study to Evaluate the Safety and Immunogenicity Following Immunization of GEN2-Recombinant COVID-19 Vaccine (CHO Cells,NVSI-06-08) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 1,848 (estimated)
- Sponsor
- National Vaccine and Serum Institute, China · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This is randomized, blinded and controlled design. Among the randomly selected subjects who have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell), based on a step-wise approach, the subjects will receive one dose of recombinant COVID-19 vaccine sequentially at different shedules of 4-6 months, 7-9 months and \>9 months after two doses of vaccination, and the subjects vaccinated at different schedules will be randomly assigned to different sequential immunization groups. At the same time, each sequential immunization group will be matched with a control group with the inactivated COVID-19 vaccine (vero cells) as the booster dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08) | Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08) in the deltoid muscle of the upper arm |
| BIOLOGICAL | Inactivated COVID-19 vaccine (Vero cells) | Intramuscular injection of Inactivated COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm |
| BIOLOGICAL | 3 doses Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08) | Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08) in the deltoid muscle of the upper arm on 0，30，60 days |
Timeline
- Start date
- 2021-10-14
- Primary completion
- 2023-12-01
- Completion
- 2024-02-01
- First posted
- 2021-10-06
- Last updated
- 2023-02-01
Locations
1 site across 1 country: United Arab Emirates
Source: ClinicalTrials.gov record NCT05069129. Inclusion in this directory is not an endorsement.