At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 144 enrolled
Drug / intervention
Engerix™-Bbiological
Likely dose
Engerix™-B 10µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Administration of a Challenge Dose of Hepatitis B Vaccine in Subjects Who Previously Received Engerix™-B Vaccine.
In Brief
A Phase 4 clinical trial evaluating Engerix™-B for Hepatitis B. Completed, enrolled 144 participants across 3 sites in 2 countries.
Detailed Summary
To evaluate the response to an additional dose (challenge dose) of hepatitis B vaccine, when given to subjects who had received primary vaccination of Engerix™-B vaccine approximately 72-78 months ago. This protocol posting deals with objectives \& outcome measures of the challenge phase. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesAustralia, Belgium
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2007
Enrollment StartNov 2007
Primary CompletionMay 2008
TodayJul 2026
First PostedSep 3, 2007
Enrollment StartNov 28, 2007
Primary CompletionMay 14, 2008
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 18.8 years ago
Interventions
Engerix™-Bbiological
One dose (10µg Hepatitis B surface antigen (HBsAg))