A Phase 3 interventional study of Trivalent influenza subunit vaccine Influvac in Influenza, sponsored by Solvay Biologicals. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-08-13.
Sponsored by Solvay Biologicals · Phase 3, Interventional, and Prevention
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).
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 120 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →This is the only study on the registry with Solvay Biologicals as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: Trivalent influenza subunit vaccine Influvac
3x 15mcg HA per 0.5 ml, trivalent one injection at Day 1
Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Influvac® 2008/2009
Time frame: 2 and 3 weeks
HI derived parameters: seroprotection, seroconversion and mean fold increase (CHMP)
Time frame: 2 and 3 weeks
This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.
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