NCT01631110

Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains

Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2012/2013-Season Influenza Vaccine in Elderly and Young Subjects According to EMA Regulations

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Crucell Holland BV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study is to assess whether the influenza vaccine Inflexal V for season 2012/2013 fulfills the EMA requirements for re-registration of influenza vaccines.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Inflexal V	Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V

Timeline

• Start date: 2012-07-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2012-06-28
• Last updated: 2013-12-20
• Results posted: 2013-12-20

Locations

1 site across 1 country: Switzerland