tetano
Editor, Senior Moderator
Vaccine. 2014 Jul 18. pii: S0264-410X(14)00939-6. doi: 10.1016/j.vaccine.2014.07.013. [Epub ahead of print]
Comparison of the safety and immunogenicity of an MF59?-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects.
Frey SE1, Reyes MR2, Reynales H3, Bermal NN4, Nicolay U4, Narasimhan V4, Forleo-Neto E4, Arora AK5.
Author information
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).
Copyright ? 2014. Published by Elsevier Ltd.
KEYWORDS:
Adjuvant; Elderly; Influenza vaccine; MF59; Non-inferiority; Superiority
PMID:
25045825
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/25045825
Comparison of the safety and immunogenicity of an MF59?-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects.
Frey SE1, Reyes MR2, Reynales H3, Bermal NN4, Nicolay U4, Narasimhan V4, Forleo-Neto E4, Arora AK5.
Author information
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).
Copyright ? 2014. Published by Elsevier Ltd.
KEYWORDS:
Adjuvant; Elderly; Influenza vaccine; MF59; Non-inferiority; Superiority
PMID:
25045825
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/25045825