CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 363 enrolled
Drug / intervention
Investigational H7N1 vaccine GSK2789869A +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/NCT01949090
NCT01949090Phase 2Completed
CompareCT.gov

An Observer-blind Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine(s) GSK2789869A Administered in Adults 65 Years of Age and Older

GlaxoSmithKline·interventional·Posted Sep 24, 2013·Updated Nov 17, 2017

In Brief

A Phase 2 clinical trial evaluating Investigational H7N1 vaccine GSK2789869A and Placebo for Influenza. Completed, enrolled 363 participants across 8 sites in 2 countries.

Detailed Summary

The purpose of this placebo controlled study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals H7N1 influenza vaccine in subjects 65 years of age and older. The study will evaluate safety related events and antibody immune responses to different formulations of study vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 24, 2013
Enrollment StartSep 25, 2013
Primary CompletionDec 4, 2013
Study CompletionOct 23, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 12.8 years ago

Interventions

Investigational H7N1 vaccine GSK2789869Abiological

Two doses of GSK2789869A H7N1 vaccine administered intramuscularly to the deltoid region at Day 0 and Day 21.

Placebobiological

Two doses of placebo administered intramuscularly to the deltoid region at Day 0 and Day 21.