NCT01013675

Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Elderly

Randomized, Double-blind, Active -Controlled Trial to Assess Safety and Immunogenicity of Solvay's Cell-derived Influenza Vaccine, Including Revaccination, in Elderly Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 622 (actual)
• Sponsor: Abbott Biologicals · Industry
• Sex: All
• Age: 61 Years
• Healthy volunteers: Accepted

Summary

A controlled, double-blind study to determine the immunogenicity and safety of influenza cell derived vaccine in elderly subjects.

Detailed description

This current phase II study is to pursue objectives similar to those of the ongoing adult phase II trial, but to expand into the elderly population who are more than 60 years of age. The results of this randomized, double blind, egg derived influenza vaccine (Influvac) - controlled, parallel-trial, in healthy elderly subjects are to be conducted over two consecutive years in multiple centers in Europe. At study initiation 600 subjects will be randomly allocated to receive the cell-derived or egg-derived influenza vaccine. At start of the second year subjects will be randomly re-allocated following stratification based upon the initial drug they were allocated and had received.

Conditions

• Influenza Vaccines

Interventions

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

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2009-11-16
• Last updated: 2011-10-27

Locations

12 sites across 3 countries: Czechia, Estonia, Lithuania