NCT00479921

Annual Study to Investigate Influenza Vaccine Due to New Virus Strains for the 2007/2008 Influenza Season in Europe

Immunogenicity and Reactogenicity of Trivalent Influenza Subunit Vaccine Influvac® for the Season 2007/2008. An Open, Baseline-Controlled Multi-Center Study in Two Groups of Healthy Subjects: Adults and Elderly

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Solvay Pharmaceuticals · 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 healthy subjects: subjects aged \>= 18 and \<= 60 years and subjects \>= 61 years of age (elderly).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Trivalent influenza subunit vaccine

Timeline

• Start date: 2007-06-01
• First posted: 2007-05-30
• Last updated: 2009-01-30

Locations

2 sites across 2 countries: Belgium, Germany