Evaluation of serological trials submitted for annual re-licensure of influenza vaccines to regulatory authorities between 1992 and 2002

Vaccine

Volumn 28, Issue 2, 2009, Pages 392-397

  Voordouw, A C G ^a,b   Beyer, W E P ^a   Smith, D J ^a,c,e   Sturkenboom, M C J M ^a   Stricker, B H Ch ^a,d  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b MEDICINES EVALUATION BOARD   (Netherlands)

^c UNIVERSITY OF CAMBRIDGE   (United Kingdom)

^d Drug Safety Unit   (Netherlands)

^e NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

Annual update trial; CHMP criteria; Regulatory requirement; Seasonal influenza vaccine; Serology

Indexed keywords

ANTIBODY; INFLUENZA VACCINE;

ADULT; AGED; ARTICLE; ASSAY; CLINICAL ASSESSMENT; CLINICAL EFFECTIVENESS; CLINICAL EVALUATION; COMORBIDITY; CONTROLLED STUDY; DATA ANALYSIS; DEMOGRAPHY; FEMALE; HUMAN; IMMUNOGENICITY; INFLUENZA; INFLUENZA VACCINATION; MALE; METHODOLOGY; PRIORITY JOURNAL; SAMPLE SIZE; SEROLOGY;

ADOLESCENT; ADULT; CLINICAL TRIALS AS TOPIC; HUMANS; INFLUENZA VACCINES; MIDDLE AGED; VACCINES, INACTIVATED; YOUNG ADULT;

EID: 70849094897     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2009.09.138     Document Type: Article

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