At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 596 enrolled

Drug / intervention

TWINRIX™ +4 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/NCT00289731

NCT00289731Phase 4Completed

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Evaluate the Effect of Several Risk Factors That Are Likely to Influence the Immunogenicity of GSK Biologicals' Combined Hepatitis A & B Vaccine, vs Separately Administered Monovalent Hepatitis A and Hepatitis B Vaccines

GlaxoSmithKline·interventional·Posted Feb 10, 2006·Updated Nov 15, 2019

In Brief

A Phase 4 clinical trial evaluating TWINRIX™, Engerix™-B, and 3 other interventions for Hepatitis B and Hepatitis A. Completed, enrolled 596 participants across 9 sites in 3 countries.

Detailed Summary

The focus of this study is to evaluate how risk factors like age, gender, body mass index, smoking, alcohol consumption, etc. can influence immune response when subjects are vaccinated with GSK Biologicals' combined hepatitis A/hepatitis B vaccine or monovalent hepatitis A and B vaccines (from GSK Biologicals' or different manufacturers). 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, Hepatitis A

CountriesBelgium, Czechia, Germany

Collaborators--

Timeline

Phase 4CompletedFinished

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartNov 2003

Primary CompletionDec 2004

First PostedFeb 2006

TodayJul 2026

First PostedFeb 10, 2006

Enrollment StartNov 24, 2003

Primary CompletionDec 21, 2004

TodayJul 2, 2026

Enrollment to primary: 1.1 yearsPosted 20.4 years ago

Interventions

TWINRIX™biological

Intramuscular injection, 3 doses

Engerix™-Bbiological

Intramuscular injection, 3 doses

HAVRIX™biological

Intramuscular injection, 2 doses

HB VAX PRO™biological

Intramuscular injection, 3 doses

Vaqta™biological

Intramuscular injection, 2 doses