drugset / Trial / NCT04185545
Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates
RandomizedParallel-groupDouble-blindPrevention
Summary
This phase III trial aims to assess the efficacy, safety and immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in neonates, lot-to-lot consistency, and antigen interference with co-administered EPI vaccines
Timeline
- Start
- 2020-10-30
- Primary completion
- 2022-04-30
- Completion
- 2023-05-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rotavirus RV3 Vaccine (Bio Farma) | Vaccine | 1 ml | Oral |