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Safety and Immunogenicity of UNAIR Inactivated COVID-19 Vaccine in Healthy Adults
NCT05226429Phase 2
Key facts
- Status
- Unknown
- Start
- Feb 2022
- Primary completion
- Apr 2023
- Countries
- 1
- Sponsor
- Dr. Soetomo General Hospital
- Modality
- Vaccines & Immunotherapeutics
- Drugs
- INAVAC
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 2, randomised, single-blind trial of INAVAC in coronavirus disease 2019 (COVID-19) (3 arms), sponsored by Dr. Soetomo General Hospital. Primary endpoints: Solicited clinical (local and systemic), laboratory, and unsolicited adverse events, SARS-CoV-2 neutralization antibodies and 2 more. Status: unknown.
02
Design
3 arms- Study design
- RandomizedSingle-blind
UNAIR 3mcg
UNAIR Inactivated COVID-19 Vaccine 3 microgram
UNAIR 5mcg
UNAIR Inactivated COVID-19 Vaccine 5 microgram
CoronaVac
CoronaVac Biofarma COVID-19 Vaccine (Active Control)
03
Who it enrols
Healthy adults aged 18 and older without prior COVID-19 vaccination or infection.
04
Endpoints
Primary
Solicited clinical (local and systemic), laboratory, and unsolicited adverse events
SARS-CoV-2 neutralization antibodies
SARS-CoV-2 binding antibodies
Th1 and Th2 immune response
Secondary
Solicited clinical, laboratory, and unsolicited adverse events
SARS-CoV-2 neutralization and binding antibodies, Th1/Th2
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