title: First-in-human clinical trials with vaccines--what regulators want.
authors.affiliation: Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany. goeka@pei.de
authors.forename: Karen B
authors.initials: KB
authors.lastname: Goetz
authors.forename: Michael
authors.initials: M
authors.lastname: Pfleiderer
authors.forename: Christian K
authors.initials: CK
authors.lastname: Schneider
mesh_terms: D000276:Adjuvants, Immunologic; D000941:Antigens / Q000276:immunology; D002648:Child; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards / Q000706:statistics & numerical data; D004305:Dose-Response Relationship, Drug; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D006801:Humans; D007109:Immunity / Q000276:immunology; D007155:Immunologic Factors / Q000276:immunology; D007157:Immunologic Surveillance; D011786:Quality Control; D018570:Risk Assessment; D014611:Vaccination; D014612:Vaccines / Q000008:administration & dosage / Q000276:immunology* / Q000592:standards
chemical_list: D000276:Adjuvants, Immunologic; D000941:Antigens; D007155:Immunologic Factors; D014612:Vaccines