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Clinical Trial
. 2014;10(2):441-8.
doi: 10.4161/hv.27140. Epub 2013 Nov 15.

Immunogenicity and safety of an inactivated 2012/2013 trivalent influenza vaccine produced in mammalian cell culture (Optaflu®): an open label, uncontrolled study

Christof David Vinnemeier  1 , Johanna Fischer-Herr  1 , Seetha Meyer  2 , Katja Liebig  2 , Wiebke Theeß  3 , Gerd-Dieter Burchard  1 , Jakob P Cramer  1
Affiliations
Clinical Trial

Immunogenicity and safety of an inactivated 2012/2013 trivalent influenza vaccine produced in mammalian cell culture (Optaflu®): an open label, uncontrolled study

Christof David Vinnemeier et al. Hum Vaccin Immunother. 2014.

Abstract

Background: The present study aimed to evaluate immunogenicity and safety of the 2012/2013 seasonal influenza vaccine (Optaflu(®)) after the World Health Organization recommended two new strains for the composition.

Results: Twenty-one days post-vaccination geometric mean titers (GMTs) against A(H1N1), A(H3N2) and the B strain were 528, 935, and 201 for adults and 272, 681, and 101 for elderly subjects, respectively. The proportion of subjects with a HI titer of ≥ 40 against the three strains A(H1N1), A(H3N2) and B was 98%, 100%, and 98% in adults and 100%, 100%, and 85% in elderly subjects, respectively. Optaflu(®) met the CHMP criteria of the Committee for Medicinal Products for Human Use (CPMP/BWP/214/96). Pre-vaccination titers indicated seroprotection against the A(H1N1), the A(H3N2) and the B strain in 56%, 86%, and 54% of the adults and in 61%, 85%, and 40% of the elderly with highest titers against the A(H3N2) strain. In the safety analysis injection site pain (37%) and myalgia (31%) were the most common local and systemic reactions. No serious adverse events were recorded.

Conclusion: The 2012/2013 seasonal influenza vaccine Optaflu(®) showed good immunogenicity and an acceptable safety profile in both adults and elderly.

Methods: In this trial, 126 subjects (63 adults ≥18 to ≤60 y, 63 elderly ≥61 y) were vaccinated with a single dose Optaflu(®) containing each of the three virus strains recommended for the 2012/2013 season (A/California/7/2009(H1N1)-like strain, A/Victoria/361/2011(H3N2)-like strain, and B/Wisconsin/1/2010-like strain). Immunogenicity was assessed by hemagglutinin inhibition (HI) and single radial hemolysis (SRH) assays on day 22, the safety profile was investigated throughout the whole study period.

Keywords: H1N1; H3N2; Optaflu; influenza; pandemic; trivalent vaccine.

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Figures

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Figure 1. Inclusion and exclusion of subjects. aAdults (≥18–≤60 y); belderly (≥61 y); cimmunogenicity was analyzed as per protocol using HI and SRH assays according to CHMP criteria; dsafety assessment was conducted by collection of any solicited local and systemic reactions and collection of adverse events (adverse events were defined as solicited reactions persisting after day 4 or other than solicited local and systemic reactions reported during the study period); eone subject was not available for visit 3 and was therefore excluded from immunogenicity analysis
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