CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 2,007 enrolled
Drug / intervention
GlaxoSmithKline Biologicals' influenza vaccine GSK576389A +1 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/NCT00540592
NCT00540592Phase 2Completed
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Observer Blind Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A With Various Formulations in Adults Aged 65 Years and Above

GlaxoSmithKline·interventional·Posted Oct 8, 2007·Updated Jun 8, 2018

In Brief

A Phase 2 clinical trial evaluating GlaxoSmithKline Biologicals' influenza vaccine GSK576389A and Fluarix for Influenza. Completed, enrolled 2,007 participants across 30 sites in 4 countries.

Detailed Summary

In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 65 years and older compared to Fluarix.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesGermany, Netherlands, Sweden, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 8, 2007
Enrollment StartOct 8, 2007
Primary CompletionJun 10, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.7 years ago

Interventions

GlaxoSmithKline Biologicals' influenza vaccine GSK576389Abiological

Single dose, Intramuscular injection, 8 different formulations were tested (one per group)

Fluarixbiological

Single dose, Intramuscular injection