Detection of adverse events: What are the current sensitivity limits during clinical development?

Vaccine

Volumn 20, Issue SUPPL. 1, 2001, Pages

  Fritzell, Bernard ^a  

^a Wyeth Lederle Vaccines   (France)

Author keywords

[No Author keywords available]

Indexed keywords

FORMALDEHYDE; INACTIVATED VACCINE; LIVE VACCINE; MEASLES VACCINE; ROTAVIRUS VACCINE;

BIOLOGICAL MONITORING; CLINICAL TRIAL; DRUG EFFICACY; DRUG INDUCED DISEASE; DRUG SENSITIVITY; DRUG TOLERABILITY; FOLLOW UP; HUMAN; IMMUNIZATION; IMMUNOGENICITY; INCIDENCE; INFECTION PREVENTION; INTUSSUSCEPTION; LICENSING; MEASLES; MEDICAL ASSESSMENT; MOLECULAR SIZE; NOTE; ONSET AGE; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RISK FACTOR; STATISTICAL ANALYSIS; VACCINATION; VIRUS DETECTION;

EID: 0035888205     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0264-410X(01)00291-2     Document Type: Note

References (2)

1. Intussusception among isnfants given an oral rotavirus vaccine
2. Adverse events and vaccination: The lack of power and predictability of infrequent events in pre-licensure study