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Volumn , Issue 941, 2007, Pages 133-188

Guidelines to assure the quality, safety and efficacy of live attenuated rotavirus vaccines (oral)

Author keywords

[No Author keywords available]

Indexed keywords

CELL DNA; DILUENT; LIVE VACCINE; ROTAVIRUS VACCINE;

EID: 39649121236     PISSN: 05123054     EISSN: None     Source Type: Book Series    
DOI: None     Document Type: Review
Times cited : (5)

References (25)
  • 1
    • 30744464369 scopus 로고    scopus 로고
    • WHO Expert Committee on Biological Standardization
    • WHO Guidelines on nonclinical evaluation of vaccines, Fifty-fourth report. Geneva, World Health Organization, 2005, Annex, 927
    • WHO Guidelines on nonclinical evaluation of vaccines. In: WHO Expert Committee on Biological Standardization. Fifty-fourth report. Geneva, World Health Organization, 2005, Annex 1 (WHO Technical Report Series, No. 927).
    • WHO Technical Report Series , vol.1
  • 2
    • 39649088836 scopus 로고    scopus 로고
    • Guidelines on clinical evaluation of vaccines: regulatory expectations. In: WHO Expert Committee on Biological Standardization. Fifty-second report. Geneva, World Health Organization, 2002, Annex 1 (WHO Technical Report Series, No. 924).
    • Guidelines on clinical evaluation of vaccines: regulatory expectations. In: WHO Expert Committee on Biological Standardization. Fifty-second report. Geneva, World Health Organization, 2002, Annex 1 (WHO Technical Report Series, No. 924).
  • 3
    • 27744592023 scopus 로고    scopus 로고
    • WHO Consultative Group. Report of a meeting on quality, safety and efficacy specifications for live attenuated rotavirus vaccines. Mexico City, Mexico, 8-9 February, 2005. Vaccine 23:5478-5487.
    • WHO Consultative Group. Report of a meeting on quality, safety and efficacy specifications for live attenuated rotavirus vaccines. Mexico City, Mexico, 8-9 February, 2005. Vaccine 23:5478-5487.
  • 4
    • 0025258878 scopus 로고
    • Rotavirus disease in Finnish children: Use of numerical scores for clinical severity of diarrhoeal episodes
    • Ruuska T, Vesikari T. Rotavirus disease in Finnish children: Use of numerical scores for clinical severity of diarrhoeal episodes. Scandinavian Journal of Infectious Diseases, 1990, 22:259-267.
    • (1990) Scandinavian Journal of Infectious Diseases , vol.22 , pp. 259-267
    • Ruuska, T.1    Vesikari, T.2
  • 5
    • 39649103985 scopus 로고    scopus 로고
    • Guidelines on transmissible spongiform encephalopathies in relation to biological and pharmaceutical products. Geneva, World Health Organization, 2003
    • Guidelines on transmissible spongiform encephalopathies in relation to biological and pharmaceutical products. Geneva, World Health Organization, 2003 (http://www.who.int.biologicals).
  • 6
    • 39649101194 scopus 로고    scopus 로고
    • Requirements for the use of animal cells as in vitro substrates for the production of biologicals. In: WHO Expert Committee on Biological Standardization. Forty-seventh report. Geneva, World Health Organization, 1998, Annex 1 (WHO Technical Report Series, No. 878).
    • Requirements for the use of animal cells as in vitro substrates for the production of biologicals. In: WHO Expert Committee on Biological Standardization. Forty-seventh report. Geneva, World Health Organization, 1998, Annex 1 (WHO Technical Report Series, No. 878).
  • 7
    • 33644624022 scopus 로고    scopus 로고
    • Adaptation of the WHO guideline for residual DNA in parenteral vaccines on continuous cells lines to a limit for oral vaccines
    • Lebron JA et al. Adaptation of the WHO guideline for residual DNA in parenteral vaccines on continuous cells lines to a limit for oral vaccines. Developments in Biologicals, 2006, 123:35-44.
    • (2006) Developments in Biologicals , vol.123 , pp. 35-44
    • Lebron, J.A.1
  • 8
    • 0018341077 scopus 로고
    • Biological activity of polyoma viral DNA in mice and hamsters
    • Israel MA et al. Biological activity of polyoma viral DNA in mice and hamsters. Journal of Virology 1979, 29:990-996.
    • (1979) Journal of Virology , vol.29 , pp. 990-996
    • Israel, M.A.1
  • 9
    • 30644468981 scopus 로고    scopus 로고
    • Development and application of a quantitative RT-PCR potency assay for a pentavalent rotavirus vaccine (RotaTeq®)
    • Ranheim T et al. Development and application of a quantitative RT-PCR potency assay for a pentavalent rotavirus vaccine (RotaTeq®). Journal of Virological Methods, 2006, 131:193-201.
    • (2006) Journal of Virological Methods , vol.131 , pp. 193-201
    • Ranheim, T.1
  • 10
    • 39649107013 scopus 로고    scopus 로고
    • Recommendations for the production and control of poliomyelitis vaccine (oral). In: WHO Expert Committee on Biological Standardization. Fiftieth report, Geneva, World Health Organization, 2002 (WHO Technical Report Series, No. 904).
    • Recommendations for the production and control of poliomyelitis vaccine (oral). In: WHO Expert Committee on Biological Standardization. Fiftieth report, Geneva, World Health Organization, 2002 (WHO Technical Report Series, No. 904).
  • 11
    • 39649101803 scopus 로고    scopus 로고
    • Guidelines for the production and control of Japanese encephalitis vaccine (live) for human use. WHO Expert Committee on Biological Standardization. Fifty-first report. Geneva, World Health Organization, 2002, Annex 3 (WHO Technical Report Series, No. 910).
    • Guidelines for the production and control of Japanese encephalitis vaccine (live) for human use. WHO Expert Committee on Biological Standardization. Fifty-first report. Geneva, World Health Organization, 2002, Annex 3 (WHO Technical Report Series, No. 910).
  • 12
    • 39649125073 scopus 로고    scopus 로고
    • Guidelines for the production and quality control of candidate tetravalent dengue virus vaccines (live). WHO Expert Committee on Biological Standardization. Fifty-fifth report. Geneva, World Health Organization, 2005, Annex 1 (WHO Technical Report Series, No. 932).
    • Guidelines for the production and quality control of candidate tetravalent dengue virus vaccines (live). WHO Expert Committee on Biological Standardization. Fifty-fifth report. Geneva, World Health Organization, 2005, Annex 1 (WHO Technical Report Series, No. 932).
  • 13
    • 39649085022 scopus 로고    scopus 로고
    • Good manufacturing practices for biological products. In: WHO Expert Committee on Biological Standardization. Forty-second report. Geneva, World Health Organization, 1992, Annex 1 (WHO Technical Report Series, No. 822).
    • Good manufacturing practices for biological products. In: WHO Expert Committee on Biological Standardization. Forty-second report. Geneva, World Health Organization, 1992, Annex 1 (WHO Technical Report Series, No. 822).
  • 14
    • 32644488514 scopus 로고    scopus 로고
    • 3rd ed. Geneva, World Health Organization
    • Laboratory biosafety manual, 3rd ed. Geneva, World Health Organization, 2004.
    • (2004) Laboratory biosafety manual
  • 15
    • 39649102246 scopus 로고    scopus 로고
    • Requirements for the use of animal cells as in vitro substrates for the production of biologicals (Addendum 2003). In: WHO Expert Committee on Biological Standardization. Fifty-fourth report. Geneva, World Health Organization, 2005, Annex 4 (WHO Technical Report Series, No. 927).
    • Requirements for the use of animal cells as in vitro substrates for the production of biologicals (Addendum 2003). In: WHO Expert Committee on Biological Standardization. Fifty-fourth report. Geneva, World Health Organization, 2005, Annex 4 (WHO Technical Report Series, No. 927).
  • 16
    • 39649103750 scopus 로고    scopus 로고
    • General requirements for the sterility of biological substances (Requirements for Biological Substances No. 6, revised 1973, amendment 1995). In: WHO Expert Committee on Biological Standardization. Forty-sixth report. Geneva, World Health Organization, 1995, Annex 3 (WHO Technical Report Series No. 872).
    • General requirements for the sterility of biological substances (Requirements for Biological Substances No. 6, revised 1973, amendment 1995). In: WHO Expert Committee on Biological Standardization. Forty-sixth report. Geneva, World Health Organization, 1995, Annex 3 (WHO Technical Report Series No. 872).
  • 17
    • 39649120698 scopus 로고    scopus 로고
    • Requirements for the collection, processing and quality control of blood, blood components and plasma derivatives (Requirements for Biological Substances No. 27, revised 1992). In: WHO Expert Committee on Biological Standardization. Forty-third report. Geneva, World Health Organization, 1994 (WHO Technical Report Series, No. 840).
    • Requirements for the collection, processing and quality control of blood, blood components and plasma derivatives (Requirements for Biological Substances No. 27, revised 1992). In: WHO Expert Committee on Biological Standardization. Forty-third report. Geneva, World Health Organization, 1994 (WHO Technical Report Series, No. 840).
  • 18
    • 39649114227 scopus 로고    scopus 로고
    • Tests for extraneous agents in viral vaccines for human use (General method No. 2.6.16). European Pharmacopoeia 4th ed, 148-149.
    • Tests for extraneous agents in viral vaccines for human use (General method No. 2.6.16). European Pharmacopoeia 4th ed, 148-149.
  • 19
    • 39649112278 scopus 로고    scopus 로고
    • Requirements for measles vaccines (Live). WHO Expert Committee on Biological Standardizaton. Thirty-eighth Report. World Health Organization, 1988, Annex 5 (WHO Technical Report Series, No. 771).
    • Requirements for measles vaccines (Live). WHO Expert Committee on Biological Standardizaton. Thirty-eighth Report. World Health Organization, 1988, Annex 5 (WHO Technical Report Series, No. 771).
  • 20
    • 39649100088 scopus 로고    scopus 로고
    • Good manufacturing practices for pharmaceutical products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second report. Geneva, World Health Organization, 1992, Annex 1 (WHO Technical Report Series, No. 823).
    • Good manufacturing practices for pharmaceutical products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second report. Geneva, World Health Organization, 1992, Annex 1 (WHO Technical Report Series, No. 823).
  • 21
    • 11144229298 scopus 로고    scopus 로고
    • Live vaccine strategies to prevent rotavirus disease
    • 3rd ed. New York, Marcel Dekker
    • Ward R.L et al. Live vaccine strategies to prevent rotavirus disease. New generation vaccines, 3rd ed. New York, Marcel Dekker, 2004:607-620.
    • (2004) New generation vaccines , pp. 607-620
    • Ward, R.L.1
  • 22
    • 23944442798 scopus 로고    scopus 로고
    • More on RotaShield and intussusception: The role of age at the time of vaccination
    • Simonsen L et al. More on RotaShield and intussusception: the role of age at the time of vaccination. Journal of Infectious Disease, 2005, 192:S36-43.
    • (2005) Journal of Infectious Disease , vol.192
    • Simonsen, L.1
  • 23
    • 0025258878 scopus 로고
    • Rotavirus disease in Finnish children: Use of numerical scores for clinical severity of diarrhoeal episodes
    • Ruuska T, Vesikari T. Rotavirus disease in Finnish children: Use of numerical scores for clinical severity of diarrhoeal episodes. Scandinavian Journal of Infectious Diseases, 1990, 22:259-267.
    • (1990) Scandinavian Journal of Infectious Diseases , vol.22 , pp. 259-267
    • Ruuska, T.1    Vesikari, T.2
  • 24
    • 0023804906 scopus 로고
    • Protective effect of WC3 vaccine against rotavirus diarrhea in infants during a predominantly serotype 1 rotavirus season
    • Clark et al. Protective effect of WC3 vaccine against rotavirus diarrhea in infants during a predominantly serotype 1 rotavirus season. Journal of Infectious Diseases, 1988, 158:570-587.
    • (1988) Journal of Infectious Diseases , vol.158 , pp. 570-587
    • Clark1
  • 25
    • 0027102860 scopus 로고    scopus 로고
    • WHO Expert Committee on Biological Standardization
    • Guidelines for national authorities on quality assurance for biological products, Forty-second report. Geneva, World Health Organization, 1992, Annex, 822
    • Guidelines for national authorities on quality assurance for biological products. In: WHO Expert Committee on Biological Standardization. Forty-second report. Geneva, World Health Organization, 1992, Annex 2 (WHO Technical Report Series, No. 822).
    • WHO Technical Report Series , vol.2


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