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

Influenza Vaccines Clinical Trial

Official title: 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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza Vaccines
• Influenza, Human

• NCT number: NCT01013675
• Study type: Interventional
• Source: Abbott
• Status: Completed
• Phase: Phase 2
• Start date: November 2009
• Completion date: April 2011