UNAIR Inactivated COVID-19 Vaccine Phase III (Immunobridging Study)

PHASE3UnknownINTERVENTIONAL
Enrollment

4,005

Participants

Timeline

Start Date

June 28, 2022

Primary Completion Date

March 28, 2023

Study Completion Date

May 28, 2023

Conditions
COVID-19 PandemicCOVID-19 Vaccines
Interventions
BIOLOGICAL

Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) 5 µg

Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) contains purified S protein of SARS-CoV-2 - Dose: 5 µg, aluminium hydroxide gel, 10 mM L-Histidine buffer, 0.005%, Tween Polysorbate 80, and 0.9% Sodium chloride. Vaccine will be prepared in vial (1 ml per vial). One vial will be used for one injection only. The vial should be shaken well before injection.

BIOLOGICAL

CoronaVac Biofarma COVID-19 Vaccine

Control vaccine in this study is existing CoronaVac-BioFarma inactivated COVID-19 vaccine which has been used widely in Indonesia

Trial Locations (5)

60115

RECRUITING

Airlangga University Hospital, Surabaya

65112

RECRUITING

Dr. Saiful Anwar General Hospital, Malang

67161

RECRUITING

Dr. Soetomo General Hospital, Surabaya

68111

RECRUITING

Dr. Soebandi General Hospital, Jember

68118

RECRUITING

Jember Paru Hospital, Jember

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Indonesia-MoH

OTHER_GOV

collaborator

Universitas Airlangga

OTHER

collaborator

Bioxis Pharmaceuticalls

INDUSTRY

lead

Dr. Soetomo General Hospital

OTHER_GOV