NCT01885117

Safety and Immunogenicity of One Dose of Seasonal Trivalent Influenza Virus Vaccine (TIVf, Purified Surface Antigen, Inactivated, Egg Derived) in Adults, Aged 18 Years and Above

A Phase III, Open Label, Single Arm, Multi Center Study to Evaluate Safety and Immunogenicity of a Trivalent, Surface Antigen Inactivated Subunit Influenza Virus (Fluvirin®) in Healthy Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The present study is designed to confirm the safety and immunogenicity of trivalent, surface antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61 years and the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI) at approximately 21 days post immunization. The vaccine composition will be based on the World Health Organization (WHO) recommended influenza strains for the 2013/2014 Northern Hemisphere vaccine. The results of this study are intended to support the use of this vaccine in future influenza seasons if the recommended vaccine composition remains the same, in compliance with the requirements of the current European Union (EU) recommendations for clinical trials related to yearly licensing of influenza vaccines.

Conditions

• Human Influenza

Interventions

Type	Name	Description
BIOLOGICAL	TIVf	Trivalent Influenza Virus Vaccine (purified surface antigen, inactivated, egg-derived)

Timeline

• Start date: 2013-08-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2013-06-24
• Last updated: 2014-03-12
• Results posted: 2014-03-12

Locations

1 site across 1 country: Germany