NCT01591837

A Study to Assess the Immunogenicity and Safety of CSL's 2012/2013 Formulation of Enzira® Vaccine in Healthy Volunteers

A Phase IV, Single-Centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2012/2013 Formulation of the Enzira® Vaccine in Two Groups of Healthy Volunteers: 'Adults' (Aged 18 to 59 Years) and 'Older Adults' (Aged 60 Years or Older)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Seqirus · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a study to assess the immune (antibody) response and safety of the 2012/2013 formulation of Enzira® (CSL Influenza vaccine) in healthy adult volunteers aged 18 years or older.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	CSL Influenza Vaccine	The study vaccine (CSL Influenza Vaccine) is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2012/2013 influenza season). The vaccine will be administered by intramuscular or subcutaneous injection.

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2012-05-04
• Last updated: 2018-06-27
• Results posted: 2013-11-18

Locations

1 site across 1 country: United Kingdom