CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 841 enrolled
Drug / intervention
A/turkey H5N1 vaccine +2 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/NCT00719043
NCT00719043Phase 2Completed
CompareCT.gov

A Trial to Evaluate the Safety and Immunogenicity of Monovalent H5N1 Vaccine in Adults >=18 Yrs of Age

GlaxoSmithKline·interventional·Posted Jul 21, 2008·Updated Jul 9, 2018

In Brief

A Phase 2 clinical trial evaluating A/turkey H5N1 vaccine, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia), and 1 other intervention for Influenza. Completed, enrolled 841 participants across 13 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine whether GSK's avian flu vaccine GSK 1557484A is immunogenic and safe when given to adults aged \>=18 years. This Protocol Posting has been updated following Amendments 1-3 of the Protocol, Dec 2009. The impacted sections are study design and outcome measures.

Study Details

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

Timeline

Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 21, 2008
Enrollment StartJul 11, 2008
Primary CompletionApr 22, 2010
Study CompletionFeb 18, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.9 years ago

Interventions

A/turkey H5N1 vaccinebiological

Administered as an intramuscular (IM) injection

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)biological

Administered as an intramuscular (IM) injection

Placebobiological

Administered as an intramuscular (IM) injection