The European CHMP criteria for influenza vaccine immunogenicity cannot be improved by the use of confidence intervals

Vaccine

Volumn 24, Issue 44-46, 2006, Pages 6643-6644

  Nauta, Jozef J P ^a   de Bruijn, Iris A ^a  

^a Solvay Pharmaceuticals Inc   (Netherlands)

Author keywords

CHMP criteria; Confidence intervals; Influenza vaccine

Indexed keywords

INFLUENZA VACCINE;

ARTICLE; CONFIDENCE INTERVAL; HUMAN; IMMUNOGENICITY; INFLUENZA; INFLUENZA VACCINATION; PRIORITY JOURNAL;

CONFIDENCE INTERVALS; EUROPE; HUMANS; INFLUENZA VACCINES; INFLUENZA, HUMAN;

EID: 33846264147     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2006.05.053     Document Type: Article

References (3)

1. Wood J.M., and Levandowski R.A. The influenza vaccine licensing process. Vaccine 21 (2003) 1786-1788
2. Note for guidance on harmonisation of requirements for influenza vaccines. Committee for Human Medicinal Products; 1997 [http://www.emea.eu.int/pdfs/human/bwp/021496en.pdf].
3. Stephen S. Added values. Controversies concerning randomisation and additivity in clinical trials. Stat Med 23 (2004) 3729-3753