drugset / Trial / NCT01463683
Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062)
RandomizedParallel-groupDouble-blindPrevention
Summary
This is a study to evaluate immunogenicity, safety, and tolerability of 2XP HEPTAVAX™-II compared with the 1XP HEPTAVAX™-II in healthy Japanese young adults.
Timeline
- Start
- 2011-11-29
- Primary completion
- 2012-11-06
- Completion
- 2012-11-06
Outcome
Met primary endpoint
paper Seroprotection rates in mpHBV SC were non-inferior to that in Heptavax®-II SC PMID 29553862 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | 1XP HEPTAVAX™-II | Unknown | 10 ug | Subcutaneous |
| Subject | 2XP HEPTAVAX™-II | Unknown | 10 ug | Subcutaneous |