First-in-human clinical trials with vaccines--what regulators want.
Goetz
Karen B
KB
Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany. goeka@pei.de
Pfleiderer
Michael
M
Schneider
Christian K
CK
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
D000276:Adjuvants, Immunologic; D000941:Antigens; D007155:Immunologic Factors; D014612:Vaccines