CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 267 enrolled
Drug / intervention
Engerix™-B (thiomersal-free) 20µg +2 morebiological
Likely dose
Engerix™-B (thiomersal-free) 20µgfrom 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.

Search/NCT00343915
NCT00343915Phase 3Completed
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Long-term Study of Immune Response Persistence of GSK Biologicals' 2-dose Thiomersal-free Engerix™-B and 3-dose Preservative-free Engerix™-B Vaccines in Subjects Aged 11-15 Yrs

GlaxoSmithKline·interventional·Posted Jun 23, 2006·Updated Jun 10, 2019

In Brief

A Phase 3 clinical trial evaluating Engerix™-B (thiomersal-free) 20µg, 10 μg Engerix™-B (preservative-free), and 1 other intervention for Hepatitis B. Completed, enrolled 267 participants across 4 sites in 3 countries.

Detailed Summary

To evaluate the persistence of antibodies against hepatitis B at 30, 42, 54 and 66 months after the first dose of the hepatitis B primary vaccination course. Subjects were aged 11 to 15 years at the time of the primary vaccination course. At the time of enrollment in the present long-term follow-up study subjects were aged 13 to 18 years. 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, Ukraine
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 23, 2006
Enrollment StartApr 21, 2004
Primary CompletionJan 10, 2008
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 20.0 years ago

Interventions

Engerix™-B (thiomersal-free) 20µgbiological

In the primary study: 2 deep intramuscular injections (Months 0, \& 6)

10 μg Engerix™-B (preservative-free)biological

In the primary study: 3 deep intramuscular injections (months 0, 1 \& 6)

placebobiological

In the primary study: 1 deep intramuscular injection (month 1)