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


CONCLUSIONS
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.
University Medical Center Hamburg-Eppendorf; I. Department for Internal Medicine; Section Tropical Medicine; Hamburg, Germany; Bernhard Nocht Center for Clinical Trials (BNCCT); Hamburg, Germany.
Christof David
CD
Vinnemeier
University Medical Center Hamburg-Eppendorf; I. Department for Internal Medicine; Section Tropical Medicine; Hamburg, Germany; Bernhard Nocht Center for Clinical Trials (BNCCT); Hamburg, Germany.
Johanna
J
Fischer-Herr
Novartis Vaccines and Diagnostics GmbH; Marburg, Germany.
Seetha
S
Meyer
Novartis Vaccines and Diagnostics GmbH; Marburg, Germany.
Katja
K
Liebig
Bernhard Nocht Center for Clinical Trials (BNCCT); Hamburg, Germany.
Wiebke
W
Theeß
University Medical Center Hamburg-Eppendorf; I. Department for Internal Medicine; Section Tropical Medicine; Hamburg, Germany; Bernhard Nocht Center for Clinical Trials (BNCCT); Hamburg, Germany.
Gerd-Dieter
GD
Burchard
University Medical Center Hamburg-Eppendorf; I. Department for Internal Medicine; Section Tropical Medicine; Hamburg, Germany; Bernhard Nocht Center for Clinical Trials (BNCCT); Hamburg, Germany.
Jakob P
JP
Cramer
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000914:Antibodies, Viral / Q000097:blood; D018929:Cell Culture Techniques; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology; D053122:Influenza A Virus, H3N2 Subtype / Q000276:immunology; D009981:Influenza B virus / Q000276:immunology; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D063806:Myalgia / Q000453:epidemiology; D010146:Pain / Q000453:epidemiology; D013678:Technology, Pharmaceutical; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
D000914:Antibodies, Viral; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated
H1N1; H3N2; Optaflu; influenza; pandemic; trivalent vaccine