A phase IIa, observer-blind, multi-country, multicentre, randomised study to evaluate the immunogenicity, safety and reactogenicity of the GlaxoSmithKline Biologicals' quadrivalent influenza vaccine (QIV) adjuvanted with various doses of the AS03 (GSK2584786A), administered in children aged 6 to 35 months, and compared to non-adjuvanted QIV and Fluarix.
Phase of Trial: Phase II
Latest Information Update: 26 Oct 2016
At a glance
- Drugs Influenza virus vaccine (Primary) ; GSK 2321138A
- Indications Influenza virus infections
- Focus Adverse reactions; Pharmacodynamics
- Sponsors GlaxoSmithKline
- 23 Apr 2012 Actual patient number 4 added as reported by ClinicalTrials.gov.
- 23 Apr 2012 Actual end date changed from Oct 2011 to Mar 2011 as reported by ClinicalTrials.gov.
- 17 Apr 2012 Planned number of patients changed from 4 to 1120 as reported by European Clinical Trials Database.