drugset / Trial / NCT05226429
UNAIR Inactivated COVID-19 Vaccine
Phase 1/2
Unknown
495 enrolled
Dr. Soetomo General Hospital
Bioxis Pharmaceuticalls · collabIndonesia-MoH · collabUniversitas Airlangga · collab
RandomizedParallel-groupDouble-blindPrevention
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.
Timeline
- Start
- 2022-02-08
- Primary completion
- 2023-04-06
- Completion
- 2023-07-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CoronaVac-BioFarma | Vaccine | — | — |
| Subject | UNAIR Inactivated Covid-19 Vaccine | Unknown | 3 ug | — |
| Subject | UNAIR Inactivated Covid-19 Vaccine | Unknown | 5 ug | — |