NCT00999206

Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza Vaccine

Randomized, Double-Blind Study to Assess Safety, Immunogenicity, and Lot Consistency of Solvay's Cell-Derived Influenza Vaccine and Its Non-Inferiority Compared to Influvac®.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,138 (actual)
• Sponsor: Abbott Biologicals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A phase 3 study to obtain additional safety and immunogenicity data on Solvay's cell-derived seasonal trivalent subunit influenza vaccine in adult and elderly subjects without significant illnesses and to demonstrate consistency of the immunogenicity of the three lots of the same vaccine, comparison of cell-derived vaccine to Solvay's egg-derived vaccine including assessment of non-inferior immunogenicity

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Influenza Vaccine	surface antigen, inactivated, prepared in cell cultures
BIOLOGICAL	Influenza Vaccine	surface antigen, inactivated, prepared in egg (influvac ®)
BIOLOGICAL	Influenza Vaccine	surface antigen, inactivated, prepared in cell cultures
BIOLOGICAL	Influenza Vaccine	surface antigen, inactivated, prepared in cell cultures

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2009-10-21
• Last updated: 2011-08-26

Locations

19 sites across 2 countries: Australia, New Zealand