Non-pertussis components of combination vaccines: Problems with potency testing

Biologicals

Volumn 27, Issue 2, 1999, Pages 177-181

  Sesardic, D ^a   Dawes, C S ^a   McLellan, K ^a   Durrani, Z ^a   Yost, S E ^a   Corbel, M J ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

DIPHTHERIA PERTUSSIS TETANUS HAEMOPHILUS INFLUENZAE TYPE B VACCINE;

CLINICAL TRIAL; DRUG EFFICACY; DRUG FORMULATION; DRUG INFORMATION; DRUG POTENCY; DRUG SAFETY; DRUG STABILITY; HUMAN; IMMUNOGENICITY; LABORATORY TEST; NONHUMAN; PRIORITY JOURNAL; SHORT SURVEY;

HAEMOPHILUS; HAEMOPHILUS INFLUENZAE SEROTYPE B; HEPATITIS B VIRUS; POLIOVIRUS;

EID: 0032724878     PISSN: 10451056     EISSN: None     Source Type: Journal    
DOI: 10.1006/biol.1999.0205     Document Type: Article

References (18)

1. Corbel MJ. Control testing of combined vaccines: a consideration of potential problems and approaches. Biologicals. 22:1994;353-360.
2. Williams JC, Goldenthal KL, Burnes DL, Lewis BP. Combined vaccines and simultaneous administration: current issues and prospective. 1995;28-30 Ann NY Acad Sci.
3. Heininger U, Cherry JD, Christenson PD. Comparative study of Lederle/Takeda acellular and Lederle whole-cell pertussis component diphtheria-tetanus-pertussis vaccines in infants in Germany. Vaccine. 12:1994;81-86.
4. Podda A, Carapella DeL, Contu B. Comparative study of a whole-cell pertussis vaccine and a recombinant acellular pertussis vaccine. J Pediatr. 124:1994;921-925.
5. Edwards KM, Meade BD, Decker MD. Comparison of 13 acellular pertussis vaccines: overview and serologic response. Pediatr (Suppl.). 1995;548-557.
6. Huang L-M, Lee C-Y, Lin T-Z. Responses to primary and a booster dose of acellular, component, and whole-cell pertussis vaccines initiated at 2 months of age. Vaccine. 14:1996;916-922.
7. Miller E, Ashworth LAE, Redhead K. Effect of schedule on reactogenicity and antibody persistence of acellular and whole-cell pertussis vaccines: value of laboratory tests as predictors of clinical performance. Vaccine. 15:1997;51-60.
8. Galazka AM, Robertson SE. Immunisation against diphtheria with special emphasis on immunisation of adults. Vaccine. 14:1996;845-857.
9. European Pharmacopoeia Monograph V.2.2.7. Assay of diphtheria vaccine adsorbed, 1985.
10. Gustafsson L, Hallander HO, Olin P. A controlled trial of a two-component acellular, a five-component acellular and a whole-cell pertussis vaccine. N Engl J Med. 334:1996;349-355.
11. Gustafsson, L, Hallander, HO, Olin, P, Efficacy trial of acellular pertussis vaccines. Technical report trial 1. Contact No 1-AI- 15125, 1996.
12. Greco D, Salmaso S, Mastrantonio P, Ciofi Degli Atti ML, Giammanco A, Panei P, Blackwelder WC, Klein DL, Wassiliak SGF. A controlled trial of two acellular vaccines and one whole-cell vaccine against pertussis. N Engl J Med. 334:1996;341-348.
13. European Pharmacopoeia Monograph V.2.2.9. Assay of tetanus vaccine adsorbed, 1985.
14. World Health Organization Technical Report Series No. 760. Annex 4. Requirements for diphtheria toxoid, pertussis vaccine, tetanus toxoid, and combined vaccines, 82, 86, 1957.
15. Report of the Expert Panel VIII. European Commission COST/STD Initiative. New vaccines, especially new combined vaccines.
16. Bell F, Heath P, Shackley F. Poor response to Hib (PRP-T) vaccine when combined with an acellular pertussis/diphtheria/tetanus vaccine for primary immunisation in infants. Biologicals. 27:1999;113.
17. Fitzgerald, EA, Overview of the methods for potency testing of diphtheria and tetanus toxoids in United States, Manclark, 61, 64.
18. Gupta RK, Siber RG. Guinea-pig model for assessing interference in the immunogenicity of different components of a comination vaccine comprising of diphtheria, tetanus, acellular pertussis (DTaP) vaccine and Haemophilus influenzae type B capsular polysaccharide conjugate. Biologicals. 27:1999;167-176.