title: Immunogenicity, safety and consistency of new trivalent inactivated influenza vaccine.
abstract: To augment the available influenza vaccine supply, a phase III study was conducted to evaluate the immunogenicity, safety, and consistency of a new trivalent inactivated influenza vaccine manufactured by CSL Limited. Healthy adults (ages 18-64) were randomized to receive either a single dose of TIV from multi-dose vials with thimerosal, TIV from pre-filled syringes without thimerosal, or placebo. Of the TIV recipients, 97.8% achieved a post-vaccination titer > or =40 against H1N1, 99.9% against H3N2 component, and 94.2% against influenza B. Few local or systemic adverse events were noted after vaccination with either TIV presentation. TIV was well tolerated and immunogenic.
authors.affiliation: Vanderbilt University School of Medicine and Pediatrics, Vanderbilt University Medical Center, 1161 21st Avenue South, Nashville, TN 37232, USA. keipp.talbot@vanderbilt.edu
authors.forename: H Keipp
authors.initials: HK
authors.lastname: Talbot
authors.forename: Wendy
authors.initials: W
authors.lastname: Keitel
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Cate
authors.forename: John
authors.initials: J
authors.lastname: Treanor
authors.forename: James
authors.initials: J
authors.lastname: Campbell
authors.forename: Rebecca C
authors.initials: RC
authors.lastname: Brady
authors.forename: Irene
authors.initials: I
authors.lastname: Graham
authors.forename: Cornelia L
authors.initials: CL
authors.lastname: Dekker
authors.forename: Dora
authors.initials: D
authors.lastname: Ho
authors.forename: Patricia
authors.initials: P
authors.lastname: Winokur
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Walter
authors.forename: Jillian
authors.initials: J
authors.lastname: Bennet
authors.forename: Neil
authors.initials: N
authors.lastname: Formica
authors.forename: Gunter
authors.initials: G
authors.lastname: Hartel
authors.forename: Maryanne
authors.initials: M
authors.lastname: Skeljo
authors.forename: Kathryn M
authors.initials: KM
authors.lastname: Edwards
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; 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 / Q000276:immunology* / Q000592:standards*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D013849:Thimerosal; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
chemical_list: D007252:Influenza Vaccines; D015164:Vaccines, Inactivated; D013849:Thimerosal