title: Safety, tolerability and immunogenicity of a mammalian cell-culture-derived influenza vaccine: a sequential Phase I and Phase II clinical trial.
abstract: This sequential, observer-blind, randomised, single-centre, combined Phase I and Phase II clinical trial compared the tolerability and immunogenicity of a single intramuscular dose of a novel cell-culture-derived influenza vaccine (CCIV), produced in Madin-Darby canine kidney cells, with a conventional egg-based vaccine. The immunogenicity of both vaccines was assessed by SRH assay, a well-recognized test by EMEA, in compliance with the requirements of the EU Committee for Medicinal Products for Human Use (CHMP). The Phase I part of the trial comprised 40 healthy adults (18-40 years of age); the subsequent Phase II part involved 200 healthy adult (n=80, 18-60 years of age) and elderly (n=120, > or =61 years of age) subjects. Both vaccines showed similar reactogenicity and any solicited local or systemic reactions were mostly mild or moderate. Regarding immunogenicity, both the CCIV and the control vaccine met all of the EU Committee for Medicinal Products for Human Use criteria for influenza vaccines for each strain and in both age groups. In conclusion, the CCIV produced in mammalian cell-culture is as well tolerated and as immunogenic as the control egg-based vaccine in non-elderly and elderly adults.
authors.affiliation: Novartis Vaccines, Global Clinical Research & Development, Via Fiorentina 1, 53100 Siena, Italy. nicola.groth@novartis.com
authors.forename: N
authors.initials: N
authors.lastname: Groth
authors.forename: E
authors.initials: E
authors.lastname: Montomoli
authors.forename: C
authors.initials: C
authors.lastname: Gentile
authors.forename: I
authors.initials: I
authors.lastname: Manini
authors.forename: R
authors.initials: R
authors.lastname: Bugarini
authors.forename: A
authors.initials: A
authors.lastname: Podda
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D000914:Antibodies, Viral / Q000097:blood; D018929:Cell Culture Techniques; D002460:Cell Line; D004285:Dogs; D006801:Humans; D007252:Influenza Vaccines / Q000009:adverse effects* / Q000276:immunology*; D008875:Middle Aged; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines