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

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.

Timeline

Start

2010-08

Primary completion

2011-08

Completion

2011-11

Outcome

Mixed primary results

paper The immunological equivalence of three lots of aTIV was demonstrated. PMID 25045825 ↗

paper aTIV was not only non-inferior to TIV PMID 25045825 ↗

paper Superiority was not established. PMID 25045825 ↗

Publications

• Frey SE, Reyes MR, Reynales H, Bermal NN, Nicolay U, Narasimhan V, Forleo-Neto E, Arora AK. Comparison of the safety and immunogenicity of an MF59(R)-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects. Vaccine. 2014 Sep 3;32(39):5027-34. doi: 10.1016/j.vaccine.2014.07.013. Epub 2014 Jul 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MF59 adjuvanted trivalent subunit influenza vaccine	Vaccine	0.5 ml	Intramuscular
Subject	Non-adjuvanted trivalent subunit influenza vaccine	Vaccine	0.5 ml	Intramuscular

Indications