Evaluation of safety and immunogenicity of HNVAC, an MDCK-based H1N1 pandemic influenza vaccine, in Phase I single centre and Phase II/III multi-centre, double-blind, randomized, placebo-controlled, parallel assignment studies

Immunogenicity of H5N1 influenza vaccines in elderly adults: a systematic review and meta-analysis

“…Alumadjuvanted inactivated influenza vaccines have demonstrated variable results, with effects ranging from moderate to none. [53][54][55] In this review, a study conducted by Brady 25 showed an SCR of 8% after two immunizations with 3.75 µg of an alumadjuvanted vaccine, whereas Vajo et al 36 described an SCR of 60.7% that resulted from vaccination with 3.5 µg of alumadjuvanted vaccine.…”

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

“…A wider variety of systemic reactions, including sleepiness, inappetence, irritability, and unusual crying have been reported in young children. 129 None of the systemic AEs are significantly different from those due to ECE-derived vaccine. In addition, the systemic AEs typically disappear following a short symptomatic treatment.…”

“…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.…”

“…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.…”

Influenza vaccination

“…Though most of the clinical trials reported no adverse effects of influenza vaccine1516, there were sporadic reports17. In general, the risk versus benefit analysis for influenza vaccination is an important issue to be addressed before deciding on the implementation of the vaccination17.…”