NCT01157702

Yearly Strain Variation Study, 2010/2011

An Open-Label Phase 3 Study to Assess the Immunogenicity and Safety of a Vero Cell-Derived Trivalent Seasonal Influenza Vaccine, Strain Composition 2010/2011, in an Adult and Elderly Population

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Alachua Government Services, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to verify the immunogenicity and tolerance of a trivalent seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the 2010/2011 season for yearly licensing application.

Conditions

• Influenza
• Seasonal Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated influenza vaccine (split virus, Vero cell-derived)	One 0.5 mL dose of inactivated influenza vaccine in a pre-filled syringe, administered by intramuscular injection into the musculus deltoideus in the upper arm

Timeline

• Start date: 2010-07-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2010-07-07
• Last updated: 2020-10-22

Locations

1 site across 1 country: Austria