NCT01412281

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

Randomized, Parallel-group, Double-blind, Single-center Phase III Study to Assess the Immunogenicity and Safety of the 2011/2012-season Influenza Vaccine Formulated With HA Antigen From Two Suppliers, in Elderly and Young Adult Subjects Using the Current EMA Regulations as Guideline

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 440 (actual)
• Sponsor: Crucell Holland BV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Virosomal influenza vaccine (AdImmune HA Antigen)	Virosomal influenza vaccine (surface antigen, inactivated, virosome, using AdImmune HA Antigen) 2011/2012, with intramuscular administration, containing per 0.5 mL dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus
BIOLOGICAL	Virosomal influenza vaccine (CSL HA Antigen)	Virosomal influenza vaccine (surface antigen, inactivated, virosome, using CSL HA antigen) 2011/2012 with intramuscular administration, containing per 0.5 mL dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus

Timeline

• Start date: 2011-10-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-08-09
• Last updated: 2013-09-09
• Results posted: 2013-03-22

Locations

1 site across 1 country: Switzerland