drugset / Trial / NCT01463683

Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062)

NCT01463683 ↗

Phase 3 Completed 722 enrolled Merck Sharp & Dohme LLC
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

EvaluationDrugModalityDoseRoute
Comparator 1XP HEPTAVAX™-II Unknown 10 ug Subcutaneous
Subject 2XP HEPTAVAX™-II Unknown 10 ug Subcutaneous