Immunogenicity and reactogenicity of influenza subunit vaccines produced in MDCK cells or fertilized chicken eggs

Journal of Infectious Diseases

Volumn 176, Issue SUPPL. 1, 1997, Pages

  Palache, A M ^a   Brands, R ^a   Van Scharrenburg, G J M ^a  

^a Solvay Pharmaceuticals Inc   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBODY; INFLUENZA VACCINE; VIRUS HEMAGGLUTININ;

ANIMAL CELL; ANTIBODY TITER; CELL STRAIN; CLINICAL TRIAL; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; GASTROINTESTINAL DISEASE; HUMAN; IMMUNOGENICITY; INFLUENZA; INFLUENZA VACCINATION; INTRAMUSCULAR DRUG ADMINISTRATION; NONHUMAN; NORMAL HUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; TISSUE CULTURE; URINARY TRACT INFECTION;

EID: 0030839203     PISSN: 00221899     EISSN: None     Source Type: Journal    
DOI: 10.1086/514169     Document Type: Conference Paper

References (14)

1. Tamblyn SE, Hinman AR. Pandemic planning: conclusions and recommendations. In: Hannoun C, Kendal AP, Klenk HD, Rüben FL, eds. Options for the control of influenza II. Amsterdam: Elsevier Science Publishers, 1993:457-9.
2. Aymard M, Cox NJ, Dubois G, et al. Recommendations of the 7th European Meeting of Influenza and its Prevention. Eur J Epidemiol 1994;10:525-6.
3. World Health Organization. Cell culture as a substrate for the production of influenza vaccines: memorandum from a WHO meeting. Bull World Health Organ 1995;73:431-5.
4. Center for Biologics Evaluation and Research. Food and Drug Administration. Points to consider in the characterization of cell lines used to produce biologicals. Office of the Federal Register National Archives and Records Administration. Washington DC: US Government Printing Office, 1987;PDA 21CFR 610.18.
5. WHO Expert Committee on Biological Standardization 1996. Final draft requirements for use of animal cells as in vitro substrates for the production of biologicals. World Health Organ Tech Rep Ser Requirements for biological substances. 1995;50:1-40; final draft issued 17 January 1997.
6. Council of Europe. European Pharmacopoeia. 2nd ed. Monograph 153 (Vaccines for human use). Sainte-Ruffine, France: Maisonneuve, 1995.
7. Wood JM, Schild GC, Newman RW, Seagroatt V. An improved single radial-immunodiffusion technique for the assay of influenza haemag-glutinin antigen: application for potency determinations of inactivated whole virus and subunit vaccines. J Biol Standard 1977;5:237-47.
8. WHO Collaborating Centers for Reference and Research on Influenza Surveillance. In: Concepts and procedures for laboratory-based influenza surveillance. Atlanta: WHO CCRRI, CDC, 1982:B-19.
9. Newman RW, Jennings R, Major DL, et al. Immune response of human volunteers and animals to vaccination with egg-grown influenza A(H1N1) virus is influenced by three amino acid substitutions in the haemagglutinin molecule. Vaccine 1993;11:400-6.
10. Commission of the European Community. Rules governing medicinal products in the European Community. Harmonisation of requirements for influenza vaccines. Luxembourg: European Community Publications Office 1992:93-8.
11. Beyer WEP, Palache AM, Masurel N, Sprenger MJW. Critical evaluation of parameters to assess the antibody response to influenza vaccination [abstract]. In: Abstracts of the International Conference on Options for the Control of Influenza II (1992, Courchevel, France). Amsterdam: Excerpta Medica, 1993:70.
12. Palache AM. Influenza subunit vaccine - ten years experience. Eur J Clin Res 1992;3:117-38.
13. Nicholson KG, Wiselka MJ, May A. Influenza vaccination of the elderly: perceptions and policies of general practitioners and outcome of the 1985-1986 immunisation programme in Trent, UK. Vaccine 1987;5: 302-6.
14. Schild GC, Oxford JS, de Jong JC, Webster RG. Evidence for host-cell selection of influenza virus antigenic variants. Nature 1983;303: 706-9.