Trials / Terminated
TerminatedNCT05683600
Efficacy and Safety of COVID-19 Vaccine as Booster Vaccination in Adults 18 Years of Age or Older
A Multicentre, Randomized, Double-blinded, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 as Booster Vaccination in Adults 18 Years of Age or Older
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 3,000 (actual)
- Sponsor
- Guangzhou Patronus Biotech Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This is an international multicenter clinical trial, which is planned to be conducted in several research centers in China and Pakistan. A randomized, double-blind, placebo-controlled design will be conducted to evaluate the efficacy, safety of LYB001 against COVID-19 as a booster dose in China.
Detailed description
3000 subjects aged 18 years and older who have completed two or three doses of SARS-CoV-2 inactivated vaccine 6-18 months will be enrolled in China. Participants are randomly assigned to LYB001 or placebo group at a ratio of 1:1 and receive one dose at day 0.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 | Intramuscular injection of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 in the deltoid muscle of the upper arm at day 0. The inoculation dose is 0.5 mL. |
| BIOLOGICAL | Placebo | Intramuscular injection of placebo in the deltoid muscle of the upper arm at day 0. The inoculation dose is 0.5 mL. |
Timeline
- Start date
- 2022-12-29
- Primary completion
- 2023-07-12
- Completion
- 2023-07-12
- First posted
- 2023-01-13
- Last updated
- 2023-09-28
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05683600. Inclusion in this directory is not an endorsement.