NCT01162122

Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects

A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety and Immunogenicity and the Consistency of Three Consecutive Lots of a MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects Aged 65 Years and Older

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7,109 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

The present phase III study aims to evaluate the safety and immunogenicity of MF59-adjuvanted subunit seasonal influenza vaccine and to evaluate the consistency in the manufacturing process of three consecutive lots of MF59-adjuvanted subunit seasonal influenza vaccine with respect to immunogenicity in subjects aged 65 years and older. The active comparator non-adjuvanted seasonal influenza vaccine is approved for use in this age group in the United States and will be used to provide a comparative assessment for immunogenicity and safety.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	MF59 adjuvanted trivalent subunit influenza vaccine (aTIV)	one dose 0.5 mL administered IM in the deltoid muscle of (preferably) the non-dominant arm
BIOLOGICAL	Non-adjuvanted trivalent subunit influenza vaccine (TIV)	one 0.5 mL dose administered IM in the deltoid muscle of (preferably) the non-dominant arm

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-08-01
• Completion: 2011-11-01
• First posted: 2010-07-14
• Last updated: 2014-06-26
• Results posted: 2014-06-12

Locations

38 sites across 4 countries: United States, Colombia, Panama, Philippines