NCT01229371

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

Randomized, Parallel-group, Double-blind Multi-center Phase III Study to Assess the Immunogenicity and Safety of the 2010/2011-season Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Suppliers, in Elderly and Young Adults

• 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.

Detailed description

The objectives of this study are to evaluate the humoral immunogenicity and safety of the parenteral formulation of the 2010/2011-season influenza vaccine, Inflexal V, using HA antigen obtained from 2 different production facilities, and to compare the immunogenicity of both formulations to pre-defined EMA criteria for the annual relicensing of seasonal influenza vaccines. The evaluation will be done in young adults and elderly.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Inflexal V influenza vaccine (CSL HA Antigen) 2010	Inflexal V influenza vaccine (surface antigen, inactivated, virosome, using CSL HA Antigen) 2010/2011, 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	Inflexal V influenza vaccine (AdImmune HA antigen) 2010/2011	Inflexal V influenza vaccine (surface antigen, inactivated, virosome, using AdImmune HA antigen) 2010/2011 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: 2010-10-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-10-27
• Last updated: 2013-09-09
• Results posted: 2013-03-22

Locations

2 sites across 1 country: Switzerland