(精编)Discussion of Clinical Trials to Support use of Vaccines against the 2009 H1N1 Influenza Virus教学课件.pptVIP

FDA/CBERVaccines and Related biological Products Advisory Committee Meeting Discussion of Clinical Trials to Support use of Vaccines against the 2009 H1N1 Influenza Virus Overview of Clinical Studies by NIAID/NIH July 23, 2009 Linda C. Lambert, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases National Institutes of Health Outline NIAID H1N1 vaccine trials Initial 5 protocols Clinical infrastructure TIV study in pregnant women H1N1 Outbreak: Initial Response FDA, NIAID, BARDA initiated regular discussions on vaccine-relat