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V-01 Booster Vaccination in Healthy Adults Previously Primed with Inactivated Vaccines
NCT05238649Phase 2
Key facts
- Status
- Unknown
- Start
- Nov 2021
- Primary completion
- Nov 2022
- Countries
- 1
- Sponsor
- Livzon Pharmaceutical Group Inc.
- Modality
- Vaccines & Immunotherapeutics
- Drugs
- V-01
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 2, randomised, double-blind trial of V-01 in coronavirus disease 2019 (COVID-19) (3 arms), sponsored by Livzon Pharmaceutical Group Inc. Primary endpoint: Geometric Mean Titers of SARS-CoV-2 neutralizing antibodies at 28 days. Status: unknown.
02
Design
3 arms- Study design
- RandomizedDouble-blind
V-01 10 μg
Recombinant SARS-CoV-2 Fusion Protein Vaccine 10μg
V-01 25 μg
Recombinant SARS-CoV-2 Fusion Protein Vaccine 25μg
Inactivated vaccine
SARS-Cov-2 Vaccine Inactivated (Active Control)
03
Who it enrols
Healthy adults aged 18 years and older who have completed a 2-dose regimen of SARS-CoV-2 inactivated vaccine 6 months ago. Participants must not have a history of COVID-19, severe allergies, or immunodeficiency.
04
Endpoints
Primary
Geometric Mean Titers of SARS-CoV-2 neutralizing antibodies
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