Induration at or near injection site: Case definition and guidelines for collection, analysis, and presentation of immunization safety data

Vaccine

Volumn 25, Issue 31, 2007, Pages 5839-5857

  Kohl, Katrin S ^a   Walop, Wikke ^b   Gidudu, Jane ^a   Ball, Leslie ^c   Halperin, Scott ^d   Hammer, Sandra Jo ^e   Heath, Paul ^f   Hennig, Renald ^g   Rothstein, Edward ^h   Schuind, Anne ⁱ   Varricchio, Frederick ^c  

^a CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^b PUBLIC HEALTH AGENCY OF CANADA   (Canada)

^c CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^d DALHOUSIE UNIVERSITY   (Canada)

^e CALIFORNIA DEPARTMENT OF PUBLIC HEALTH   (United States)

^f ST GEORGE'S UNIVERSITY OF LONDON   (United Kingdom)

^g Novartis Vaccine   (Germany)

^h Pennridge Pediatric Associates   (United States)

ⁱ GLAXOSMITHKLINE   (United States)

Author keywords

Adverse event; Case definition; Guidelines; Immunization; Induration

Indexed keywords

VACCINE;

ARTICLE; CASE DEFINITION; CASE STUDY; CLINICAL PRACTICE; CLINICAL RESEARCH; DATA ANALYSIS; DECISION MAKING; DRUG SAFETY; HUMAN; IMMUNIZATION; INJECTION SITE; INJECTION SITE INDURATION; OUTCOMES RESEARCH; PRACTICE GUIDELINE; PRIORITY JOURNAL; STANDARD;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DATA COLLECTION; DATA INTERPRETATION, STATISTICAL; HUMANS; IMMUNIZATION; INJECTIONS; SAFETY; TERMINOLOGY;

EID: 34447279472     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2007.04.062     Document Type: Article

References (32)

1. Ambrosch F., Fritzell B., Gregor J., Jonas S., Kollaritsch H., Teulieres L., et al. Combined vaccination against yellow fever and typhoid fever: a comparative trial. Vaccine 12 (1994) 625-628
2. Auerbach B.S., Lake A.M., Wilson M.E., et al. Dose-response to a two component acellular pertussis vaccine in infants and comparison with whole-cell vaccine. Biologicals 26 (1998) 145-153
3. Blumberg D.A., Lewis K., Min C.M., Christenson P.D., Chatfield P., and Cherry J.D. Severe reaction associated with DTP vaccine: a detailed study of children with seizures, HHE, high fevers, and persistent crying. Pediatrics 91 (1993) 1158
4. Eskola J., Käyhty H., Takala A., Rönnberg P.-R., Kela E., Peltola H., et al. Reactogenicity and immunogenicity of combined vaccines for bacteraemic diseases caused by Haemophilus influenzae type b, meningococci and pneumococci in 24 months old children. Vaccine 8 (1990) 107-110
5. Egemen A., Aksit S., Kurugöl Z., Erensoy S., Bilgiç A., and Akilli M. Low-dose intradermal versus intramuscular administration of recombinant hepatitis B vaccine: a comparison of immunogenicity in infants and preschool children. Vaccine 16 (1998) 1511-1515
6. King Jr. J.C., Vink P.E., Farley J.J., Parks M., Smilie M., Madore D., et al. Comparison of the safety and immunogenicity of a pneumococcal conjugate with a licensed polysaccharide vaccine in human immunodeficiency virus and non-human immunodeficiency virus-injected children. Pediatr Infect Dis J 15 (1996) 192-196
7. Krantz I., Sekura R., Trollfors B., Taranger J., Zackrisson G., Lagergard T., et al. Immunogenicity and safety of a pertussis vaccine composed of pertussis toxin inactivated by hydrogen peroxide, in 18- to 23-month-old children. J Pediatr 116 (1990) 539-543
8. Nahum E., Lerman Y., Cohen D., Salpon R., Danon Y.L., et al. The immune response to booster vaccination against diphtheria toxin at age 18-21 years. Isr J Med Sci 30 (1994) 600-603
9. Langue J., Ethevenaux C., Champsaur A., Fritzell B., Bégué P., and Saloiu P. Safety and immunogenicity of Haemophilus influenzae type b-tetanus toxoid conjugate, presented in a dual-chamber syringe with diphtheria-tetanus-pertussis and inactivated poliomyelitis combination vaccine. Eur J Pediatr 158 (1999) 717-722
10. Lolekha S., Hiranchote A., and Simasathen S. Safety and immunogenicity of combined or associated administration of PRP-T vaccine with diphtheria, tetanus and pertussis vaccine in Thai children. J Tropical Pediatr 47 (2001) 24-29
11. Schmitt-Grohe S., Stehr K., Cherry J.D., Heininger U., U{combining double acute accent}berall M.A., Laussucq S., et al. Minor AE in a comparative efficacy trial in Germany in infants DTaP vs DTP (Wyeth Lederle). Dev Biol Stand 89 (1997) 113
12. Andre F.E., D'Hondt E., Delem A., and Safary A. Clinical assessment of the safety and efficacy of an inactivated hepatitis A vaccine: rationale and summary of findings. Vaccine 10 Suppl. 1 (1992) S160-S168
13. Araujo O.O., Forleo-Neto E., Vespa G.N., Puccini R.F., Weckx L.W., Carvalho E.S., et al. Associated or combined vaccination of Brazilian infants with a conjugate Haemophilus influenzae type B (Hib) vaccine, a diphtheria-tetanus-whole-cell pertussis vaccine and IPV or OPV elicits protective levels of antibodies against Hib. Vaccine 19 (2001) 367-375
14. Blum M.D., Dagan R., Mendelman P.M., Pinsk V., Giordani M., Li S., et al. A comparison of multiple regimens of pneumococcal polysaccharide-meningococcal outer membrane protein complex conjugate vaccine and pneumococcal polysaccharide vaccine in toddlers. Vaccine 18 (2000) 2359-2367
15. Dagan R., Greenberg D., Goldenbertg-Gehtman P., Vidor E., Briantais P., Pinsk V., et al. Safety and immunogenicity of a new formulation on an inactivated hepatitis A vaccine. Vaccine 17 (1999) 1919-1925
16. Diez-Domingo J., Planelles M.V., Baldó J.M., et al. Ibuprofen prophylaxis for adverse reactions to diphtheria-tetanus-pertussis vaccination: a randomized trial. Curr Ther Res 59 (1998) 579-588
17. Jaiiaroensup W., Lang J., Thipkong P., Wimalaratne O., Samranwataya P., Saikasem A., et al. Safety and efficacy of purified vero cell rabies vaccine given intramuscularly and intradermally (results of a prospective randomized trial). Vaccine 16 (1998) 1559-1562
18. Lang J., Gravenstein S., Briggs D., Miller B., Froeschle J., Dukes C., et al. Evaluation of the safety and immunogenicity of a new, heat-treated human rabies immune globulin using a sham, post-exposure prophylaxis of rabies. Biologicals 26 (1998) 7-15
19. Lina B., Fletcher M.A., Valette M., Saliou P., and Aymard M. A Triton X-100-split virion influenza vaccine is safe and fulfills the Committee for Proprietary Medicinal Products (CPMP) recommendations for the European Community for immunogenicity, in children, adults and the elderly. Biologicals 28 (2000) 95-103
20. Kohl K.S., Gidudu J., Bonhoeffer J., Braun M.M., Michael Buettcher M., Chen R.T., et al. The development of standardized case definitions and guidelines for adverse events following immunization. Vaccine 25 (2007) 5671-5674
21. Rothstein E., Kohl K.S., Ball L., Halperin S.A., Halsey N., Hammer S.J., et al. Nodule at injection site as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation. Vaccine 22 (2004) 575-585
22. Afari E.A., Kamiya Y., Nkrumah F.K., Dunyo S.K., Akpedonu P., Kamiya H., et al. Randomized controlled trial of acellular diphtheria, pertussis and tetanus vaccines in southern Ghana. Ann Trop Paediatr 16 (1996) 39-48
23. Benade J.G. An analysis of DTP-associated reactions by manufacturer, batch, vaccinator, series number and infant weight. S Afr Med J 86 (1996) 1288-1290
24. Gupte M.D., Vallishayee R.S., De Britto L.J., and Anantharaman D.S. Sensitization potential and reactogenicity of BCG with and without various doses of killed Mycobacterium leprae. Int J Leprosy 60 (1992) 340-352
25. Kimura M., Kuno-Sakai H., Sato Y., Kamiya H., Nii R., Isomura S., et al. A comparative trial of the reactogenicity and immunogenicity of Takeda acellular pertussis vaccine combined with tetanus and diphtheria toxoid. Am J Dis Child 145 (1991) 734-741
26. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Guidelines for clinical safety assessment (E2a-e). Available on the world wide web: http://www.ich.org/ [last accessed February 9, 2006].
27. Council for International Organizations of Medical Sciences (CIOMS). Reporting form for International Reporting of Adverse Drug Reactions. Available on the world wide web: http://www.cioms.ch/frame_what_is_cioms.htm [last accessed February 9, 2006].
28. CDC. Guidelines for maintaining and managing the vaccine cold chain. MMWR 52 (2003) 1023-1025. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5242a6.htm [last accessed January, 26, 2007]
29. CDC. General Recommendations on Immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006;55(December (RR 15)):1-48. Also available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5515a1.htm [last accessed January, 26, 2007].
30. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 285 15 (2001) 1987-1991. http://www.consort-statement.org/Statement/revisedstatement.htm [last accessed February 9, 2006]
31. Moher D., Cook D.J., Eastwood S., Olkin I., Rennie D., and Stroup D.F. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses. Lancet 354 November (9193) (1999) 1896-1900. http://www.consort-statement.org/Initiatives/complements.htm [last accessed February 9, 2006]
32. Stroup D.F., Berlin J.A., Morton S.C., Olkin I., Williamson G.D., Rennie D., et al. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis of Observational Studies in Epidemiology (MOOSE) group. JAMA 283 15 (2000) 2008-2012. http://www.consort-statement.org/Initiatives/complements.htm [last accessed February 9, 2006]