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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

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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; Fischer-Herr, Johanna; Meyer, Seetha; Liebig, Katja; Theeß, Wiebke; Burchard, Gerd-Dieter; Cramer, Jakob P.

In: HUM VACC IMMUNOTHER, Vol. 10, No. 2, 01.02.2014, p. 441-8.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Vinnemeier, CD, Fischer-Herr, J, Meyer, S, Liebig, K, Theeß, W, Burchard, G-D & Cramer, JP 2014, 'Immunogenicity and safety of an inactivated 2012/2013 trivalent influenza vaccine produced in mammalian cell culture (Optaflu®): an open label, uncontrolled study', HUM VACC IMMUNOTHER, vol. 10, no. 2, pp. 441-8. https://doi.org/10.4161/hv.27140

APA

Vinnemeier, C. D., Fischer-Herr, J., Meyer, S., Liebig, K., Theeß, W., Burchard, G-D., & Cramer, J. P. (2014). Immunogenicity and safety of an inactivated 2012/2013 trivalent influenza vaccine produced in mammalian cell culture (Optaflu®): an open label, uncontrolled study. HUM VACC IMMUNOTHER, 10(2), 441-8. https://doi.org/10.4161/hv.27140

Vancouver

Vinnemeier CD, Fischer-Herr J, Meyer S, Liebig K, Theeß W, Burchard G-D et al. Immunogenicity and safety of an inactivated 2012/2013 trivalent influenza vaccine produced in mammalian cell culture (Optaflu®): an open label, uncontrolled study. HUM VACC IMMUNOTHER. 2014 Feb 1;10(2):441-8. https://doi.org/10.4161/hv.27140

Bibtex

@article{3e92b53df5574c078994da2bdc1cc00d,
title = "Immunogenicity and safety of an inactivated 2012/2013 trivalent influenza vaccine produced in mammalian cell culture (Optaflu{\textregistered}): an open label, uncontrolled study",
abstract = "BACKGROUND: The present study aimed to evaluate immunogenicity and safety of the 2012/2013 seasonal influenza vaccine (Optaflu({\textregistered})) 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({\textregistered}) 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({\textregistered}) 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({\textregistered}) 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.",
author = "Vinnemeier, {Christof David} and Johanna Fischer-Herr and Seetha Meyer and Katja Liebig and Wiebke Thee{\ss} and Gerd-Dieter Burchard and Cramer, {Jakob P}",
year = "2014",
month = feb,
day = "1",
doi = "10.4161/hv.27140",
language = "English",
volume = "10",
pages = "441--8",
journal = "HUM VACC IMMUNOTHER",
issn = "2164-5515",
publisher = "LANDES BIOSCIENCE",
number = "2",

}

RIS

TY - JOUR

T1 - Immunogenicity and safety of an inactivated 2012/2013 trivalent influenza vaccine produced in mammalian cell culture (Optaflu®): an open label, uncontrolled study

AU - Vinnemeier, Christof David

AU - Fischer-Herr, Johanna

AU - Meyer, Seetha

AU - Liebig, Katja

AU - Theeß, Wiebke

AU - Burchard, Gerd-Dieter

AU - Cramer, Jakob P

PY - 2014/2/1

Y1 - 2014/2/1

N2 - 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.

AB - 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.

U2 - 10.4161/hv.27140

DO - 10.4161/hv.27140

M3 - SCORING: Journal article

C2 - 24240428

VL - 10

SP - 441

EP - 448

JO - HUM VACC IMMUNOTHER

JF - HUM VACC IMMUNOTHER

SN - 2164-5515

IS - 2

ER -