drugset / Trial / NCT02152709
Study of Evaluating Safety and Immunogenicity of 10µg/0.5ml Hepatitis B Vaccine
Phase 3
Completed
1537 enrolled
Jiangsu Province Centers for Disease Control and Prevention
Beijing Tiantan Biological Products Co., Ltd. · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
The main objective of this study was to evaluate the safety and immunogenicity of 10µg/0.5ml and 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside yeast for infants and other age groups.
Timeline
- Start
- 2008-11
- Primary completion
- 2010-03
- Completion
- 2010-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hepatitis B vaccine | Vaccine | 5 ug | Intramuscular |
| Subject | Hepatitis B vaccine | Vaccine | 10 ug | Intramuscular |