CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 370 enrolled
Drug / intervention
GSK investigational vaccine 2186877A +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/NCT00992784
NCT00992784Phase 3Completed
CompareCT.gov

Observer-blind Safety and Immunogenicity Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A When Administered to Elderly Subjects

GlaxoSmithKline·interventional·Posted Oct 9, 2009·Updated Sep 21, 2018

In Brief

A Phase 3 clinical trial evaluating GSK investigational vaccine 2186877A and FluarixTM for Influenza. Completed, enrolled 370 participants across 24 sites in 3 countries.

Detailed Summary

The purpose of the study is to evaluate the safety of GSK Biologicals' influenza vaccine. Elderly subjects were randomized in the primary study (NCT00760617) and will now receive the same vaccine for the third time. For this study the masking is "observer-blind" for elderly subjects and "open" for young adult subjects.

Study Details

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

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 9, 2009
Enrollment StartOct 15, 2009
Primary CompletionMay 27, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 16.7 years ago

Interventions

GSK investigational vaccine 2186877Abiological

Single dose, intramuscular injection

FluarixTMbiological

Single dose, intramuscular injection