tetano
Editor, Senior Moderator
Hum Vaccin Immunother. 2013 Nov 15;10(2). [Epub ahead of print]
Immunogenicity and safety of an inactivated 2012/2013 trivalent influenza vaccine produced in mammalian cell culture (Optaflu?): An open label, uncontrolled study.
Vinnemeier CD, Fischer-Herr J, Meyer S, Liebig K, Thee? W, Burchard GD, Cramer JP.
Source
University Medical Center Hamburg-Eppendorf; I. Department for Internal Medicine; Section Tropical Medicine; Hamburg, Germany; Bernhard Nocht Center for Clinical Trials (BNCCT); Hamburg, Germany.
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) for 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 severe 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
PMID:
24240428
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/24240428
Immunogenicity and safety of an inactivated 2012/2013 trivalent influenza vaccine produced in mammalian cell culture (Optaflu?): An open label, uncontrolled study.
Vinnemeier CD, Fischer-Herr J, Meyer S, Liebig K, Thee? W, Burchard GD, Cramer JP.
Source
University Medical Center Hamburg-Eppendorf; I. Department for Internal Medicine; Section Tropical Medicine; Hamburg, Germany; Bernhard Nocht Center for Clinical Trials (BNCCT); Hamburg, Germany.
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) for 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 severe 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
PMID:
24240428
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/24240428