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Vaccine. 2014 Sep 3;32(39):5027-34. doi: 10.1016/j.vaccine.2014.07.013. Epub 2014 Jul 18.

Comparison of the safety and immunogenicity of an MF59®-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects.

Author information

1
Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, Saint Louis, MO, USA.
2
Research Institute for Tropical Medicine, Alabang, Muntinlupa City, Philippines.
3
Centro de Atención e Investigación Médica (CAIMED), Bogotá, Colombia.
4
Novartis Vaccines and Diagnostics Inc., Cambridge, MA, USA.
5
Novartis Vaccines and Diagnostics Inc., Cambridge, MA, USA. Electronic address: ashwani_kumar.arora@novartis.com.

Abstract

AIM:

Adjuvanted influenza vaccines can overcome the poor antibody response of conventional non-adjuvanted vaccines in the elderly. We evaluated the immunogenicity, safety and clinical effectiveness of an MF59(®)-adjuvanted trivalent influenza vaccine (aTIV) compared with a non-adjuvanted vaccine (TIV) in subjects ≥65 years old, with or without co-morbidities.

METHODS:

In 2010-2011, subjects (N=7082) were randomized to receive one dose of aTIV or TIV. Co-primary objectives were to assess lot-to-lot consistency of aTIV, non-inferiority, superiority and immunogenicity 22 days after vaccination. Clinical effectiveness, reactogenicity and serious adverse events were monitored up to Day 366.

RESULTS:

The immunological equivalence of three lots of aTIV was demonstrated. aTIV was not only non-inferior to TIV but also elicited significantly higher antibody responses at Day 22 than TIV against all homologous and heterologous strains, even in subjects with co-morbidities. Superiority was not established. Reactogenicity was higher in the aTIV group, but reactions were mild to moderate and transient.

CONCLUSIONS:

aTIV elicited a significantly higher antibody response than TIV, especially against A/H3N2 strains, although superiority by pre-defined criteria was not formally met. The study demonstrates potential immunological benefits of MF59-adjuvanted influenza vaccines for the elderly. This trial was registered with www.clinicaltrials.gov (NCT01162122).

KEYWORDS:

Adjuvant; Elderly; Influenza vaccine; MF59; Non-inferiority; Superiority

PMID:
25045825
DOI:
10.1016/j.vaccine.2014.07.013
[Indexed for MEDLINE]

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