drugset / Trial / NCT01229371

Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Suppliers

NCT01229371

Phase 3 Completed 440 enrolled Crucell Holland BV
RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this study is to assess the humoral immune response and safety of the parenteral formulation of the 2010/2011-season virosomal subunit influenza vaccine Inflexal V using two different HA antigen suppliers (AdImmune and CSL), in groups of young and elderly adults, using the EMA (European Medicines Agency) regulation as a guideline.

Timeline

Start
2010-10
Primary completion
2010-12
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Inflexal V Vaccine 0.5 ml Intramuscular

Indications