At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 276 enrolled

Drug / intervention

Twinrix™ Adult +1 morebiological

Likely dose

Twinrix Junior (3-dose schedule at 0,1,6 months) or Twinrix Adult (2-dose schedule at 0,6 months); administered as intramuscular injection in the left deltoidAI-extracted

Key inclusion· 2

✓Participation in primary study
✓Written informed consent obtained before each long term follow up visit

Key exclusion· 0

None specified.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00197184

NCT00197184Phase 3Completed

Compare CT.gov

Evaluate the Persistence of Immune Response of GSK Biologicals' Twinrix™ Vaccine, Administered According to a 0,6 Month Schedule and a 0,1,6 Month Schedule, in Healthy Children Aged Between 1-11 Years at the Time of First Vaccine Dose

GlaxoSmithKline·interventional·Posted Sep 20, 2005·Updated Aug 20, 2018

In Brief

A Phase 3 clinical trial evaluating Twinrix™ Adult and Twinrix™ Junior for Hepatitis B and Hepatitis A. Completed, enrolled 276 participants across 7 sites in 3 countries.

Detailed Summary

To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface antigen (HBs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of the study vaccine. 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

CountriesAustralia, Belgium, Spain

Collaborators--

Timeline

Phase 3CompletedFinished

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartNov 2003

Primary CompletionMar 2004

First PostedSep 2005

TodayJul 2026

First PostedSep 20, 2005

Enrollment StartNov 1, 2003

Primary CompletionMar 10, 2004

TodayJul 2, 2026

Enrollment to primary: 4 monthsPosted 20.8 years ago

Interventions

Twinrix™ Adultbiological

Intramuscular injection in the left deltoid, 2 doses, Adult formulation in primary study.

Twinrix™ Juniorbiological

Intramuscular injection in the left deltoid, 3 doses, junior formulation in primary study.