NCT02381418

Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the Southern Hemisphere 2015 Season

Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Southern Hemisphere Season 2015. An Open-Label, Baseline-Controlled Study in Two Age Groups: Adult Subjects ≥ 18 and ≤ 60 Years and Elderly Subjects ≥ 61 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Abbott · 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. The current study is a phase III A clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. The objective of this study is to investigate the immunogenicity and safety and tolerability of the changed influenza vaccine virus composition 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: 2015-03-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2015-03-06
• Last updated: 2016-12-22
• Results posted: 2016-12-22

Locations

1 site across 1 country: Australia