drugset / Trial / NCT05067894
Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine
Phase 1
Completed
54 enrolled
PT Bio Farma
Fakultas Kedokteran Universitas Indonesia · collabNational Institute of Health Research and Development, Ministry of Health Republic of Indonesia · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is To evaluate the safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose.
Timeline
- Start
- 2021-12-10
- Primary completion
- 2022-04-11
- Completion
- 2022-08-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CoronaVac | Vaccine | — | Intramuscular |
| Subject | SARS-CoV-2 Protein Subunit Recombinant Vaccine | Vaccine | 50 ug | Intramuscular |