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

PHASE3UnknownINTERVENTIONAL
Enrollment

22,500

Participants

Timeline

Start Date

August 25, 2021

Primary Completion Date

February 8, 2022

Study Completion Date

June 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 (0.5mL) /vial Vaccination route: intramuscular injection into the lateral deltoid of the upper arm Vaccination dosage: 10 μg Immunization schedule: two doses, one each on Day 0 and 21 (+7 days), respectively.~Storage condition: store at 2\~8°C protected from light Expiry date: 24 months after production date"

OTHER

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 (25)

1000

University of the Philippines - Philippine General Hospital, Manila

1118

Far Eastern University-Nicanor Reyes Medical Foundation Medical Center, Quezon City

4217

Mary Mediatrix Medical Center, Lipa City

5000

The Medical City- Iloilo, Iloilo City

Unknown

Andalas University Hospital, Padang

Medical Faculty of Mulawarman University, Samarinda

Medical Faculty of Padjadjaran University, Sumedang

Medical Faculty of UIN Syarif Hidayatullah, Tangerang

Makati Medical Center, Makati City

East Avenue Medical Center, Manila

Lung Center of the Philippines, Manila

Mary Chiles General Hospital, Manila

St. Luke's Medical Foundation Medical Center, Quezon City

Central Clinical Hospital of the Russian Academy of Sciences, Engel's

Oris LLC, Moscow

Zvezdnaya Clinic, Moscow

UZI-4D Clinic LLC, Pyatigorsk

Institute of Medical Research LLC, Saint Petersburg

Lab. of molecular virology Smorodintsev Research Institute of Influenza MoH, Saint Petersburg

"LLC Uromed", Saint Petersburg

Medical Technologies, Saint Petersburg

N.P. Bechtereva Institute of the Human Brain of the Russian Academy of Sciences, Saint Petersburg

Research Center ECO Safety LLC, Saint Petersburg

"State Budgetary Healthcare Institution Nikolaevskaya hospital", Saint Petersburg

Strategic Medical Systems LLC, Saint Petersburg

All Listed Sponsors
lead

Livzon Pharmaceutical Group Inc.

INDUSTRY