Recommendations for whole-cell pertussis vaccine

World Health Organization - Technical Report Series

Volumn , Issue 941, 2007, Pages 301-333

  Arciniega, J ^a   Corbel, M ^b   Gaines Das, R ^b   Griffiths, E ^c   Kreeftenberg, J G ^d   Jadhav, S S ^e   Xing, D ^b   Knezevic, Ivana ^f   Xing, Dorothy ^b   Griffiths, Elwyn ^c   Corbel, Michael ^b   Gaines Das, Rose ^b   Das, Rose ^b   Horiuchi, Yoshinobu ^g   Ausiello, C M ^h   Bektimirov, T A ⁱ   Chagnaud, P ^j   Dias, A ^k   Dobbelaer, R ^l   Gallegos Flores, G ^m   Girard, M ^c   Guiso, N ⁿ   Gupta, S R ^o   Horiuchi, Y ^g   Jivapaisarnpong, T ^p   Meade, B ^a   M'Henni, A ^q   Olin, P ^r   Powell, M ^s   Tahlan, A ^t,ac   Von Hunolstein, C ^h   Zhang, S ^u   Molari, E ^v   Adame, Ma Verónica Ortega ^m   Lingjiang, Y ^w   Fajardo, E Ma ^x   Qin, M ^y   Harjee, N ^z   T'Serstevens, B ^aa   Vidor, E ^ab   Behr Gross, M E ^z   Wood, D ^f   Hernandez, Carmen Rodriguez ^f   Duclos, Philippe ^f   Powel, Mair ^s   more..

^a CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

^b NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

^c HEALTH CANADA   (Canada)

^d NETHERLANDS VACCINE INSTITUTE   (Netherlands)

^e Serum Institute of India Ltd   (India)

^f WORLD HEALTH ORGANIZATION   (Switzerland)

^g NATIONAL INSTITUTE OF INFECTIOUS DISEASES   (Japan)

^h ISTITUTO SUPERIORE DI SANITÀ   (Italy)

ⁱ Tarasevic State Institute for the Standardization and Control of Medical Biological Preparations   (France)

^j French Health Products Safety Agency   (France)

^k INSTITUTO OSWALDO CRUZ   (Brazil)

^l PASTEUR INSTITUTE OF BRUSSELS   (Belgium)

^m Gerencia de Analisis Y Desarrollo de Pruebas Biológicas   (Mexico)

ⁿ INSTITUT PASTEUR   (France)

^o GOVERNMENT OF INDIA   (India)

^p MINISTRY OF PUBLIC HEALTH   (Thailand)

^q PASTEUR INSTITUTE OF TUNIS   (Tunisia)

^r SWEDISH INSTITUTE FOR INFECTIOUS DISEASE CONTROL   (Sweden)

^s MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

^t Joint Director and Government Central Research Institute   (India)

^u NATIONAL INSTITUTE FOR THE CONTROL OF PHARMACEUTICAL AND BIOLOGICAL PRODUCTS   (China)

^v UNICEF   (United States)

^w Chengdu Institute of Biological Products   (China)

^x FINLAY INSTITUTE   (Cuba)

^y Chengdu Institute of Biological Products   (China)

^z Chengdu Institute of Biological Products ^*

^aa GSK   (Belgium)

^ab SANOFI PASTEUR   (France)

^ac Government Central Research Institute   (Switzerland)

more..

Author keywords

[No Author keywords available]

Indexed keywords

PERTUSSIS VACCINE;

BORDETELLA PERTUSSIS; CULTURE MEDIUM; DISEASE CONTROL; DRUG POTENCY; HEALTH CARE ORGANIZATION; HUMAN; IMMUNOGENICITY; NONHUMAN; PERTUSSIS; PREVENTION AND CONTROL; REVIEW; RISK ASSESSMENT; VACCINATION; WORLD HEALTH ORGANIZATION;

EID: 39649124177     PISSN: 05123054     EISSN: None     Source Type: Book Series    
DOI: None     Document Type: Review

References (23)

1. Requirements for Diphtheria, tetanus, pertussis and combined vaccines. In: WHO Expert Committee on Biological Standardization. Fortieth report. Geneva, World Health Organization, 1990, Annex 2 (WHO Technical Report Series, No. 800).
2. Recommendations for diphtheria, tetanus, pertussis and combined vaccines. Amendments 2003. In WHO Expert Committee on Biological Standardization. Fifty-fourth report. Geneva, World Health Organization, 2005, Annex 5 (WHO Technical Report Series, 927).
3. Guidelines for the production and control of the acellular pertussis component of monovalent or combined vaccines. In: WHO Expert Committee on Biological Standardization. Forty-seventh Report. Geneva, World Health Organization, 1998, Annex 2 (WHO Technical Report Series, No. 878).
4. WHO position paper on pertussis vaccines. Weekly Epidemiological Record, 2005, 80:29-40.
5. Halander H et al. Shifts of Bordetella pertussis Variants in Sweden from 1970 to 2003, during three periods marked by different vaccination programs. Journal of Clinical Microbiology, 2005, 43:2856-2865.
6. Van Amersfooth et al. Analysis of Bordetella pertussis populations in European countries with different vaccination policies. Journal of Clinical Microbiology, 2005, 43:2837-2843.
7. Caro et al. Pulsed-field gel electrophoresis analysis of Bordetella pertussis populations in various European countries with different vaccine policies. Microbe and Infection, 2005, 7:976-982.
8. Miller E. Overview of recent clinical trials of acellular pertussis. Biologicals, 1999, 27:79-86.
9. Heath PT, Ramsay ME. Haemophilus influenzae type b vaccine - booster campaign. British Medical Journal, 2003. 326:1158-1159.
10. Matoo S and Cherry JD. Molecular pathogenesis, epidemiology and clinical manifestations of respiratory infections due to Bordetella pertussis and other Bordetella species. Clinical Microbiology Reviews, 2005, 18:326-382.
11. Medical Research Council. Vaccination against whooping cough: Relation between protection in children and results of laboratory tests, British Medical Journal, 1956, 2:454-462
12. Xing D et al. Laboratory testing of whole-cell pertussis vaccine: a WHO proficiency study using the Kendrick test. Vaccine, 2002, 20:342-351.
13. Alternatives to whole-cell pertussis vaccine potency assay. In: EDQM Proceedings. Geneva, European Directorate for the Quality of Medicines, Council of Europe, 2005.
14. Vaccines and biologicals: Recommendations from the Strategic Advisory Group of Experts. Weekly Epidemiological Record, 2002, 37:306.
15. Guidelines on regulatory expectations related to the elimination, reduction or replacement of thiomersal in vaccines. In: WHO Expert Committee on Biological Standardization. Fifty-third report. Geneva, World Health Organization, 2004, Annex 4 (WHO Technical Report Series, No. 926).
16. Good manufacturing practices for pharmaceutical products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-seventh Report. Geneva, World Health Organization, 2003. Annex 4 (WHO Technical Report Series, No. 908).
17. Good manufacturing practices for biological products. Geneva, World Health Organization, 1992 (WHO Technical Report Series, No. 822):20-30.
18. Guidelines on transmissible spongiform encephalopathies in relation to biological and pharmaceutical products. Geneva, World Health Organization, 2003 (WHO/BCT/QSD/03.01).
19. General requirements for the sterility of biological substances (Requirements for Biological substances no. 6, revised 1973). In: WHO Expert Committee on Biological Standardization. Twenty-fifth report. Geneva, World Health Organization, 1973 (Technical Report Series, No. 530) and amended In: WHO Expert Committee on Biological Standardization. Forty-sixth report. Geneva, World Health Organization, 1998 (WHO Technical Report Series, No. 872).
20. Guidelines for 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).
21. Guidelines for good clinical practices (GCP) for trials on pharmaceutical products. In: WHO Expert Committee on the Use of Essential Drugs, Sixth report. Geneva, World Health Organization, 1995, Annex 3 (WHO Technical Report Series, No. 850).
22. Guidelines for clinical evaluation of vaccines: regulatory expectations. In: WHO Expert Committee on Biological Standardization. Fifty-second report. Geneva, World Health Organization, 2004, Annex 1 (WHO Technical Report Series, No. 924).
23. Guidelines for national authorities on quality assurance for biological products. Geneva, World Health Organization, 1992 (WHO Technical Report Series, No. 822):31-46.