At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Immunogenicity of UNAIR Inactivated COVID-19 Vaccine in Healthy Populations Aged 18 Years and Above (Phase I/II)
In Brief
A Phase 2 clinical trial evaluating UNAIR Inactivated COVID-19 Vaccine and CoronaVac Biofarma COVID-19 Vaccine for COVID-19 Pandemic and Vaccine Reaction. Targeting 495 participants across 1 site.
Detailed Summary
This is a randomized, observer blind, controlled phase I/II study to evaluate the Safety, Reactogenicity, and Immunogenicity of UNAIR Inactivated Covid-19 Vaccine in Healthy Populations Aged 18 Years and Above. UNAIR Inactivated Covid-19 Vaccine is an inactivated vaccine developed by Airlangga University (Universitas Airlangga / UNAIR) made of SARS-CoV-2 virus isolated from a patient in Surabaya, Indonesia, composed with aluminium hydroxy gel, tween 80, and L-histidine. This study will be the first in human.
Study Details
Timeline
Interventions
UNAIR Inactivated Covid-19 Vaccine contains S protein of SARS-CoV-2 virus, 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.
Control vaccine in this study is existing CoronaVac-BioFarma inactivated COVID-19 vaccine which has been used widely in Indonesia.