CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 78 enrolled
Drug / intervention
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvantedbiological
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/NCT01416571
NCT01416571Phase 2Completed

Immunogenicity and Safety Study of GSK Biologicals' Monovalent Pandemic H5N1 Vaccine 1557484A in Adults Aged 18 - 64 Years

GlaxoSmithKline·interventional·Posted Aug 15, 2011·Updated Sep 21, 2018

In Brief

A Phase 2 clinical trial evaluating Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted for Influenza. Completed, enrolled 78 participants across 1 site.

Detailed Summary

This trial will assess the immunogenicity and safety of GSK Biologicals' vaccine GSK1557484A, prepared from old concentrated monobulk material, in adults aged 18 to 64 years, when administered up to 5 years following production.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 15, 2011
Enrollment StartAug 12, 2011
Primary CompletionNov 29, 2011
Study CompletionSep 28, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.9 years ago

Interventions

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvantedbiological

Intramuscular (IM), two doses