CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,596 enrolled
Drug / intervention
GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season] +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/NCT00532298
NCT00532298Phase 2Completed
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Non-Inferiority of GlaxoSmithKline Biologicals' Influenza Vaccine (GSK576389A) 1 Container Over 2 Container Presentation in Adults Aged 65 Years and Over

GlaxoSmithKline·interventional·Posted Sep 20, 2007·Updated Jun 8, 2018

In Brief

A Phase 2 clinical trial evaluating GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season], GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season], and 2 other interventions for Influenza. Completed, enrolled 1,596 participants across 6 sites in 3 countries.

Detailed Summary

This observer blind study is designed to compare the immune response of GSK Biologicals' influenza vaccine GSK576389A when administered using various presentations in adults aged 65 years and older. 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--
ConditionsInfluenza
CountriesDenmark, Estonia, Norway
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2007
Enrollment StartSep 20, 2007
Primary CompletionNov 1, 2007
Study CompletionNov 2, 2007
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 18.8 years ago

Interventions

GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season]biological

Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2006-2007 influenza season.

GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season]biological

Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2007-2008 influenza season.

Fluarix [NH 2006/07 season]biological

Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.

Fluarix [NH 2007/08 season]biological

Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.