title: Safety and immunogenicity of a trivalent, inactivated, mammalian cell culture-derived influenza vaccine in healthy adults, seniors, and children.
abstract: We performed randomized, double-blind, controlled trials to assess the safety and immunogenicity of an inactivated, Madin Darby Canine Kidney (MDCK)-derived cell line produced influenza vaccine in healthy adults (19-50 years), children (3-12 years) and the elderly (> or =65 years). We studied three lots of cell culture-derived vaccine and one lot of licensed egg-derived vaccine in healthy adults (n=462), two lots of cell culture-derived vaccine and one lot of egg-derived vaccine in seniors (n=269), and one lot of each vaccine in children (n=209). Adverse events were collected during the first 3 days post-immunization; serum was collected before and 1 month after immunization. Rates of local and systemic adverse reactions were similar with both vaccines. An injection site adverse event rated at least moderate severity was reported by 21.9% of children who received the egg-derived vaccine and 25.0% of those who received the cell culture-derived vaccine. In healthy adults the proportions were 12.1 and 15.3%, respectively and 6.7 and 6.3%, respectively in seniors. Systemic events of at least moderate severity were 12.4 and 12.5% in children, 19.8 and 13.6% in healthy adults, and 14.1 and 9.7% in seniors; none of these differences were statistically significant. The antibody response against all three viruses was similar between the two vaccines. From 83 to 100% of children, healthy adults and seniors achieved hemagglutination inhibition titers in excess of 40 post-immunization. We conclude that the cell culture-derived vaccine was safe and immunogenic in children, healthy adults and seniors.
authors.affiliation: Department of Pediatrics, Clinical Trials Research Center, Dalhousie University, IWK Health Centre, 5850 University Avenue, NS, B3J 3G9, Halifax, Canada. shalperin@iwkgrace.ns.ca
authors.forename: Scott A
authors.initials: SA
authors.lastname: Halperin
authors.forename: Bruce
authors.initials: B
authors.lastname: Smith
authors.forename: Taoufik
authors.initials: T
authors.lastname: Mabrouk
authors.forename: Marc
authors.initials: M
authors.lastname: Germain
authors.forename: Pierre
authors.initials: P
authors.lastname: Trépanier
authors.forename: Thomas
authors.initials: T
authors.lastname: Hassell
authors.forename: John
authors.initials: J
authors.lastname: Treanor
authors.forename: Richard
authors.initials: R
authors.lastname: Gauthier
authors.forename: Elaine L
authors.initials: EL
authors.lastname: Mills
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000914:Antibodies, Viral / Q000097:blood; D018929:Cell Culture Techniques; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007252:Influenza Vaccines / Q000009:adverse effects* / Q000276:immunology; D008297:Male; D008875:Middle Aged
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines