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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.
Hum Vaccin Immunother. 2014; 10(2):441-8.HV

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.

Authors+Show Affiliations

University Medical Center Hamburg-Eppendorf; I. Department for Internal Medicine; Section Tropical Medicine; Hamburg, Germany; Bernhard Nocht Center for Clinical Trials (BNCCT); Hamburg, Germany.University Medical Center Hamburg-Eppendorf; I. Department for Internal Medicine; Section Tropical Medicine; Hamburg, Germany; Bernhard Nocht Center for Clinical Trials (BNCCT); Hamburg, Germany.Novartis Vaccines and Diagnostics GmbH; Marburg, Germany.Novartis Vaccines and Diagnostics GmbH; Marburg, Germany.Bernhard Nocht Center for Clinical Trials (BNCCT); Hamburg, Germany.University Medical Center Hamburg-Eppendorf; I. Department for Internal Medicine; Section Tropical Medicine; Hamburg, Germany; Bernhard Nocht Center for Clinical Trials (BNCCT); Hamburg, Germany.University Medical Center Hamburg-Eppendorf; I. Department for Internal Medicine; Section Tropical Medicine; Hamburg, Germany; Bernhard Nocht Center for Clinical Trials (BNCCT); Hamburg, Germany.

Pub Type(s)

Clinical Trial
Journal Article

Language

eng

PubMed ID

24240428

Citation

Vinnemeier, Christof David, et al. "Immunogenicity and Safety of an Inactivated 2012/2013 Trivalent Influenza Vaccine Produced in Mammalian Cell Culture (Optaflu®): an Open Label, Uncontrolled Study." Human Vaccines & Immunotherapeutics, vol. 10, no. 2, 2014, pp. 441-8.
Vinnemeier CD, Fischer-Herr J, Meyer S, 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 Vaccin Immunother. 2014;10(2):441-8.
Vinnemeier, C. D., Fischer-Herr, J., Meyer, S., Liebig, K., Theeβ, 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. Human Vaccines & Immunotherapeutics, 10(2), 441-8. https://doi.org/10.4161/hv.27140
Vinnemeier CD, 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 Vaccin Immunother. 2014;10(2):441-8. PubMed PMID: 24240428.
* Article titles in AMA citation format should be in sentence-case
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 - Theeβ,Wiebke, AU - Burchard,Gerd-Dieter, AU - Cramer,Jakob P, Y1 - 2013/11/15/ PY - 2013/11/19/entrez PY - 2013/11/19/pubmed PY - 2015/1/6/medline KW - H1N1 KW - H3N2 KW - Optaflu KW - influenza KW - pandemic KW - trivalent vaccine SP - 441 EP - 8 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 10 IS - 2 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. SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/24240428/Immunogenicity_and_safety_of_an_inactivated_2012/2013_trivalent_influenza_vaccine_produced_in_mammalian_cell_culture__Optaflu®_:_an_open_label_uncontrolled_study_ L2 - https://www.tandfonline.com/doi/full/10.4161/hv.27140 DB - PRIME DP - Unbound Medicine ER -