Influenza Clinical Trial
Official title:
Comparison of the Protective Efficacy of Flublok® Quadrivalent Versus Licensed Inactivated Influenza Vaccine (IIV4) in Healthy, Medically Stable Adults ≥50 Years of Age
The goal of this study is to establish that Flublok Quadrivalent is non-inferior to fully licensed (traditional approval status) quadrivalent inactivated influenza vaccine (IIV4) in protecting against laboratory-confirmed clinical influenza disease in the ≥50 year age population.
The goal of this study is to establish that Flublok Quadrivalent is non-inferior to fully
licensed (traditional approval status) quadrivalent inactivated influenza vaccine (IIV4) in
protecting against laboratory-confirmed clinical influenza disease in the ≥50 year age
population. Real-time Polymerase Chain Reaction (rtPCR) will be used to confirm influenza
infection and to type the strains involved, as molecular methodologies have been demonstrated
to be more sensitive than other more traditional methodologies, e.g. culture. For
rtPCR-positive clinical samples, reserved aliquots will be processed for culture, so that
antigenic similarity to the HA present in study vaccines can be tested.
In various clinical studies the investigators demonstrated that the immune response against
the influenza A viruses is improved as a result of the higher hemagglutinin content.
Furthermore, influenza virus disease and hospitalization associated with influenza-related
illness in older adults (> 50 years) was considerably reduced (90%) following vaccination
with TIV, even though the circulating influenza A strain was antigenically dissimilar to that
in the vaccine. However, more recently Skowronski et al. reported that the low influenza
vaccine effectiveness in 2012-2013 was not associated with antigenic drift but was instead
related to mutations in the egg-adapted H3N2 vaccine strain. Flublok manufactured using
recombinant technology does not contain the mutations responsible for the reported lower
effectiveness and may thus offer improved protection when mutations such as those described
are induced in the process of adapting the influenza virus to growth in eggs.
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