At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 244 enrolled
Drug / intervention
Twinrix™ Adult +1 morebiological
Likely dose
TWINRIX Adult: 2 doses intramuscularly in deltoid region OR TWINRIX Junior: 3 doses intramuscularly in deltoid region (as administered in prior trial HAB-084)AI-extracted
Key inclusion· 3
- ✓Healthy male and female volunteers
- ✓Previously vaccinated in study HAB-084
- ✓Willing and able to provide written informed consent for blood sampling visits
Key exclusion· 0
None specified.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluate Persistence of Immune Response of GSK Biologicals' TWINRIX™ Vaccine Administered According to 0,6 Month Schedule Versus TWINRIX™ JUNIOR Administered According to 0,1,6 Month Schedule, in Subjects Aged 12-15 Years at Time of First Vaccine Dose
In Brief
A Phase 3 clinical trial evaluating Twinrix™ Adult and Twinrix™ Junior for Hepatitis B and Hepatitis A. Completed, enrolled 244 participants across 2 sites in 2 countries.
Detailed Summary
To evaluate the persistence of anti-hepatitis A virus (anti-HAV) and anti-hepatitis B surface antigen (anti-HBs) antibodies up to 6, 7, 8, 9 and 10 years after administration of the first dose of the study vaccine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Hepatitis A
CountriesBelgium, Czechia
Collaborators--
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2004
Primary CompletionJun 2004
First PostedSep 2005
TodayJul 2026
First PostedSep 20, 2005
Enrollment StartMay 1, 2004
Primary CompletionJun 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 20.8 years ago
Interventions
Twinrix™ Adultbiological
Intramuscular administration in the deltoid region (2 doses).
Twinrix™ Juniorbiological
Intramuscular administration in the deltoid region (3 doses).