Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Booster Study

PHASE3CompletedINTERVENTIONAL
Enrollment

10,381

Participants

Timeline

Start Date

November 3, 2021

Primary Completion Date

February 18, 2022

Study Completion Date

April 14, 2023

Conditions
COVID-19 Pandemic
Interventions
BIOLOGICAL

Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01)

"Appearance: Creamy white suspension Dosage form: Suspension for injection Strength: 10 μg (0.5 mL) /vial Vaccination route: Intramuscular injection into the lateral deltoid of the upper arm Vaccination dosage: 10 μg (0.5 mL) Immunization schedule: 1 dose on Day 0, which should be 3-6 months after the second dose of 2-dose regimen of inactive vaccine (BBIBP-CorV or CoronaVac).~Storage condition: Store at 2-8 °C protected from light Expiry date: 24 months temporarily"

BIOLOGICAL

Blank Preparation of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01)

The dosage, appearance, administration method, and other aspects are consistent with that of investigational vaccine, except that no vaccine antigen is contained.

Trial Locations (18)

44000

Shifa International Hospitals, Islamabad

52250

Central Hospital Gujranwala, Gujranwala

54660

Al Khidmat Foundation - Surraya Azeem Waqf Hospital, Lahore

Avicenna Dental College, Lahore

Central Park Medical College and Hospital, Lahore

74200

Aga Khan University Hospital, Karachi

Dow University Hospital, Karachi

Sindh Infectious Diseases Hospital & Research Center, Karachi

Unknown

Sarawak General Hospital, Kuching

Sunway Medical Centre Velocity (SMCV) Cheras, Kuala Lumpur

Hospital Pakar Sultanah Fatimah, Muar town

Sunway Medical Centre (SunMed), Petaling Jaya

Hospital Pulau Pinang, Pulau Pinang

Klinik Kesihatan Seremban 2, Seremban

Seri Manjung Hospital, Seri Manjung

Hospital Sibu, Sibu

Hospital Sultan Abdul Halim, Sungai Petani

Hospital Taiping, Taiping

All Listed Sponsors
lead

Livzon Pharmaceutical Group Inc.

INDUSTRY