partial quality control of inactivated split human influenza vaccine 2008-9

background and aims: influenza vaccination is one of the best way to prevent and control influenza worldwide. it is manufactured by who-licensed companies based on the who expertise committee annually. the aim of this study was partial quality control of the commercial human influenza vaccine 2008-9 and its matching with the circulating strains. materials and methods: the trivalent imported vaccine was cultured in bacterial and fungal media, injected to the mice and inoculated into the allantoic cavity of embryonated chicken eggs (eces). hemagglutination-inhibition (hi) assay was carried out on pre and post vaccination serum samples. the bacterial endotoxin was assessed by lal assay. the hemagglutinin (ha) content of the vaccine was measured using srid. heterogenecity of the circulating influenza strains during 2008-9 seasons in tehran in comparison to the vaccine strains was determined. results: no bacterial contamination and no occurrence of mortality and morbidity in animal was observed. the mean fold increase of hi antibody titer in subjects without previous vaccination for h1n1, h3n2 and b strains were 6.7, 3.3 and 1.8 respectively, while in subjects with previous vaccination were 4, 1.6 and 1.1 for same strains. amino acid variation was found in tehran h1n1 isolates but the h3n2 isolates showed higher genetic resemblance to the 2008-9 vaccine strain. conclusion: the sterility, safety, and efficacy of the vaccine were approved and there was some variation in a/h1n1 but not in a/h3n2 isolates in comparison with the vaccine strain.