NCT01146015

Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2010/2011 Season

Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Season 2010/2011. An Open-Label, Baseline-Controlled Multi-Center Study in Two Groups: Adult Subjects and Elderly Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Abbott Biologicals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of subjects in good health: subjects aged \>= 18 and \<= 60 years and subjects \>= 61 years of age (elderly)

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Trivalent influenza subunit vaccine Influvac	3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2010-06-17
• Last updated: 2011-08-26

Locations

2 sites across 2 countries: Belgium, Germany