NCT01306305

A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2010/2011 Influenza Virus Strains for the Northern Hemisphere

Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2010/2011-season Influenza Vaccine in Elderly and Young Subjects According to European Medicines Agency (EMEA) Regulations

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Crucell Holland BV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A study to assess whether the Northern Hemisphere 2010/2011 season influenza vaccine Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Inflexal V	Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2010-2011 season, containing per 0.5 mL dose: * 15 µg hemagglutinin (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 Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Day 1

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2011-03-01
• Last updated: 2013-09-09
• Results posted: 2012-03-29

Locations

1 site across 1 country: Switzerland