NCT01880697

Safety and Immunogenicity of a Cell Derived Subunit Trivalent Nonadjuvanted Influenza Study Vaccine in Adults Aged 18 Years and Above

A Phase III, Open-Label, Single-Arm, Multicenter Study to Evaluate the Safety and Immunogenicity of a Trivalent, Surface Antigen Inactivated Subunit Influenza Virus Vaccine Produced in Mammalian Cell Culture (Optaflu®) in Healthy Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 126 (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 cell-derived, 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 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 EU recommendations for clinical trials related to yearly licensing of influenza vaccines.

Conditions

• Human Influenza

Interventions

Type	Name	Description
BIOLOGICAL	TIVc	Trivalent Influenza Virus Vaccine (surface antigen, inactivated, cell-based)

Timeline

• Start date: 2013-08-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2013-06-19
• Last updated: 2017-02-23
• Results posted: 2014-02-03

Locations

1 site across 1 country: Germany