Adaptation of a previously validated vaccination report card for use in adult vaccine clinical trials to align with the 2007 FDA Toxicity Grading Scale Guidance

Human Vaccines and Immunotherapeutics

Volumn 8, Issue 9, 2012, Pages 1208-1212

  Norquist, Josephine M ^a   Khawaja, Shazia S ^a   Kurian, Cizely ^a,b   Mast, T Christopher ^a   Liaw, Kai Li ^a   Robertson, Michael N ^a   Evans, Barbara ^a   Gutsch, David ^a   Saddier, Patricia ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b Johnson and Johnson   (United States)

Author keywords

Adverse event collection; Injection site reaction; Patient reported outcomes; Vaccination complaints; Vaccine report card; Vaccine safety

Indexed keywords

2007 FDA TOXICITY GRADING SCALE; ADAPTATION; ADULT; AGED; ARTICLE; CLINICAL TRIAL; DISEASE SEVERITY; DRUG INDUCED DISEASE; FEEDBACK SYSTEM; FEMALE; FOOD AND DRUG ADMINISTRATION; HUMAN; HUMAN EXPERIMENT; MALE; MEDICAL INFORMATION; MEDICAL RECORD; NORMAL HUMAN; PAIN; PRACTICE GUIDELINE; SKIN REDNESS; SWELLING; VACCINATION; VACCINATION REPORT CARD; VALIDATION PROCESS;

ADULT; FEMALE; HUMANS; MALE; MEDICAL RECORDS; MIDDLE AGED; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VACCINATION;

EID: 84866988392     PISSN: None     EISSN: 2164554X     Source Type: Journal    
DOI: 10.4161/hv.21408     Document Type: Article

References (11)

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