drugset / Trial / NCT05546502
Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children
Phase 3
Completed
1050 enrolled
PT Bio Farma
Andalas University · collabCenter for Child Health Universitas Gadjah Mada (CCH-PRO UGM · collabDr Cipto Mangunkusumo General Hospital · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
A Phase III, Observer-blind, randomized, active-controlled prospective intervention study
Timeline
- Start
- 2022-10-09
- Primary completion
- 2023-12-31
- Completion
- 2024-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Covovax | Vaccine | 0.5 ml | — |
| Subject | SARS-CoV-2 Protein Subunit Recombinant Vaccine | Vaccine | 0.5 ml | — |