NCT05508477

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

A Multicenter, Randomized, Double Blind, Controlled, Phase III Clinical Trial (Immunobridging Study) of Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) in Healthy Population Aged 18 Years and Above

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,005 (estimated)
• Sponsor: Dr. Soetomo General Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is a multicenter, randomized, double blind, controlled, phase III clinical trial (Immunobridging Study) to evaluate the immunogenicity and safety of Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) in healthy populations aged 18 years and above. Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) is an inactivated vaccine made of SARS-CoV-2 virus isolated from a patient in Surabaya, composed with aluminium hydroxy gel, tween 80, and L-histidine, and this study will be the first phase III in human.

Detailed description

This is a double blind randomized controlled trial - immunobridging study. There will be 2 groups in the study. One adult group (18 year-old and above) with 5 µg dose, and 1 control group using CoronaVac Bio Farma. Both vaccines will be administered with 2-dose schedule, intramuscularly. All cohorts will be followed for 6 months. This study will have two interim and one full analysis The main focus is immunogenicity and safety or reactogenicity issues. Data Safety Monitoring Board will be commissioned for this study to evaluate safety data over the study period and to review any events that meet a specific study pausing rule or any other safety issue that may arise. They will review the blinded 7 and 28 days safety data following the first dose of vaccine, and then the 7 and 28 days after the second dose. The immunogenicity data will be evaluated until 6 months after the second dose

Conditions

• COVID-19 Pandemic
• COVID-19 Vaccines

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-06-28
• Primary completion: 2023-03-28
• Completion: 2023-05-28
• First posted: 2022-08-19
• Last updated: 2022-08-29

Locations

5 sites across 1 country: Indonesia