drugset / Trial / NCT02764671
Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Neonates
Phase 4
Unknown
5000 enrolled
Shenzhen Kangtai Biological Products Co., LTD
Guangdong Provincial Institute of Biological Products And Materia Medica · collab
NaSingle-groupOpen-labelPrevention
Summary
The purpose of this study is to further evaluate the immunogenicity and safety of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates.
Timeline
- Start
- 2015-05
- Primary completion
- 2020-09
- Completion
- 2020-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | recombinant hepatitis B vaccine | Vaccine | 10 ug | — |
| Subject | recombinant hepatitis B vaccine | Vaccine | 0.5 ml | — |