At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 135 enrolled
Drug / intervention
Havrix™biological
Likely dose
Not stated in 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.
Double-blind Randomized Study to Evaluate the Immunogenicity and Reactogenicity of Two Different Lots of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Containing 1440 EL.U of Antigen Per mL and Injected According to a 0, 12 Month Schedule in Healthy Adult Volunteers
In Brief
A Phase 4 clinical trial evaluating Havrix™ for Hepatitis A. Completed, enrolled 135 participants across 1 site.
Detailed Summary
The aim of this study is to evaluate the persistence of hepatitis A antibodies at 138, 150, 162, 174,186, 198, 210, 222, 234 and 246 months after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine. This protocol posting deals with objectives \& outcome measures of the extension phase at year 11 to 20. No additional subjects will be recruited during this long-term follow-up.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis A
CountriesBelgium
Collaborators--
Timeline
Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2004
First PostedFeb 2006
Primary CompletionMar 2013
TodayJul 2026
First PostedFeb 15, 2006
Enrollment StartJan 1, 2004
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 20.4 years ago
Interventions
Havrix™biological
2 doses at 12 months interval