Immunogenicity and safety of an inactivated 2012/2013 trivalent influenza vaccine produced in mammalian cell culture (Optaflu^®)

Cell culture-based influenza vaccines: A necessary and indispensable investment for the future

“…111,112,[114][115][116][117][118][119][120]122,123,125,127,128 The SRC rates and GMR are typically the best in adults, lower in children and the lowest in the elderly, whereas the SRP rates are similar in children and adults while being slightly lower in the elderly. 114,116,118,120,122,123,125,128 When comparing between subtypes of the viruses used as part of a trivalent vaccine, overall responses in terms of SRC, SRP and GMR are equivalent against the different influenza A subtypes H3N2 and H1N1, whereas responses to influenza B virus are comparatively weaker. 117,125,128 Some studies have shown that substantial proportion of the subjects retain seroprotective titres for at least 6 months, and in some cases, more than a year, 115,123 and that the dose can be reduced at least by half by using MF59 as an adjuvant.…”

“…122,123,126 The most common local AE has been pain at injection site (12-75%), followed by erythema (2-20%), induration (6-15%), swelling (2-15%), and ecchymosis (0-18%). 112,115,[116][117][118][119][120]122,123,[125][126][127][128][129] Some investigators have also reported limitation in movement, tenderness and bruising. 114,127 In general, the local reactions are mild, and are not significantly different from subjects administered ECE-derived vaccine or a placebo.…”

“…121 Since the early 1990s, reports of more than 20 clinical studies involving greater than 20,000 subjects in over a dozen countries, as well as large-scale immunization programs have further confirmed the safety and immunogenicity of MDCK cell-derived influenza vaccines. As far as safety is concerned, overall AEs have been reported in up to 84% of the subjects, 112,114,116,117,[122][123][124][125] with a higher incidence in adults (60-84%) as compared to children (50-60%) and lowest (typically 15-25%, but sometimes up to 50%) in the elderly. 114,122,123,125 Total local AEs have ranged from 10% to 84%, 112,[114][115][116][117]122,124,126 again, typically higher in adults than in children, and lowest in the elderly.…”

“…114,116,118,120,122,123,125,128 When comparing between subtypes of the viruses used as part of a trivalent vaccine, overall responses in terms of SRC, SRP and GMR are equivalent against the different influenza A subtypes H3N2 and H1N1, whereas responses to influenza B virus are comparatively weaker. 117,125,128 Some studies have shown that substantial proportion of the subjects retain seroprotective titres for at least 6 months, and in some cases, more than a year, 115,123 and that the dose can be reduced at least by half by using MF59 as an adjuvant. 122,127,[130][131][132] Whereas all the above described studies involve killed vaccines, a recent study has shown that an MDCK cell-derived LAV vaccine containing 3 reassortant virus strains does not cause AEs that are significantly different from placebo, but immunogenicity, as determined by serum antibody titres, could only be demonstrated for H3N2, but not for H1N1 or B, influenza viruses.…”

“…122,123,126 The commonest systemic AE is headache, being reported in 6.7-32% of the subjects, followed by myalgia (2-30%), fatigue (4-24%), malaise (3-25%), sweating (0-16%), chills (0-14%), and arthralgia (0-15%). 112,[114][115][116][117][118][119][120]122,123,125,126,128,129 Other systemic AEs, which are typically observed in less than 10% of the subjects, include nausea, loss of appetite, diarrhea, vomiting, fever and rash. A wider variety of systemic reactions, including sleepiness, inappetence, irritability, and unusual crying have been reported in young children.…”