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

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

SUBMITTER: Vinnemeier CD

PROVIDER: S-EPMC4185887 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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

Vinnemeier Christof David CD Fischer-Herr Johanna J Meyer Seetha S Liebig Katja K Theeß Wiebke W Burchard Gerd-Dieter GD Cramer Jakob P JP

Human vaccines & immunotherapeutics 20131115 2

<h4>Background</h4>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.<h4>Results</h4>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 thr ...[more]

PMID: 24240428

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Dataset Information

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

Publications

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

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