CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 713 enrolled
Drug / intervention
Engerix-B™ +3 morebiological
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.

Search/NCT00805389
NCT00805389Phase 2Completed
CompareCT.gov

Comparison of the Immunogenicity and Safety of Various Investigational and Licensed Formulations of Hepatitis B Surface Antigen (HBsAg) Vaccines.

GlaxoSmithKline·interventional·Posted Dec 9, 2008·Updated Aug 20, 2018

In Brief

A Phase 2 clinical trial evaluating Engerix-B™, Fendrix™, and 2 other interventions for Hepatitis B. Completed, enrolled 713 participants across 14 sites in 2 countries.

Detailed Summary

The aim of this Observer-blind study is to compare different Adjuvant Systems with the same, well-known antigen (HBsAg) already used in the GSK marketed vaccines against Hepatitis B (Engerix-BTM and FendrixTM), in order to better understand the immune response induced by each of the Adjuvant System. This Protocol Posting has been updated following Protocol amendment 6, October 2009. The section impacted is Eligibility Criteria

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesBelgium, Germany
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 9, 2008
Enrollment StartDec 15, 2008
Primary CompletionSep 29, 2010
Study CompletionJul 14, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.6 years ago

Interventions

Engerix-B™biological

2 doses intramuscular injections

Fendrix™biological

2 doses intramuscular injections

GSK Biologicals' Hepatitis B vaccines (GSK223192A)biological

2 doses intramuscular injections 3 different formulations of (GSK223192A), each administered to 1 group

HBsAg (Booster injection)biological

Single dose intramuscular injection