메뉴 건너뛰기




Volumn 25, Issue 31, 2007, Pages 5858-5874

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

Author keywords

Adverse event; Case definition; Guidelines; Immunization; Swelling

Indexed keywords

VACCINE;

EID: 34447252154     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2007.04.056     Document Type: Article
Times cited : (32)

References (27)
  • 1
    • 22944442951 scopus 로고    scopus 로고
    • Acellular pertussis vaccine safety and efficacy in children, adolescents and adults
    • Casey J.R., and Pichichero M.E. Acellular pertussis vaccine safety and efficacy in children, adolescents and adults. Rev Article Drugs 65 10 (2005) 1367-1389
    • (2005) Rev Article Drugs , vol.65 , Issue.10 , pp. 1367-1389
    • Casey, J.R.1    Pichichero, M.E.2
  • 2
    • 33746824087 scopus 로고    scopus 로고
    • Safety and immunogenicity of a pentavalent combination vaccine (diptheria, tetanus, acecullar pertussis, polio, and haemophilus influenzae type b conjugate) when administered as a fourth dose at 15 to 18 months of age
    • Scheifele D.W., Halperin S.A., Rubin E., Tapiero B., Guasparini R., Meekison W., et al. Safety and immunogenicity of a pentavalent combination vaccine (diptheria, tetanus, acecullar pertussis, polio, and haemophilus influenzae type b conjugate) when administered as a fourth dose at 15 to 18 months of age. Hum Vaccines 1 (2005) 180-186
    • (2005) Hum Vaccines , vol.1 , pp. 180-186
    • Scheifele, D.W.1    Halperin, S.A.2    Rubin, E.3    Tapiero, B.4    Guasparini, R.5    Meekison, W.6
  • 3
    • 0842283456 scopus 로고    scopus 로고
    • Adverse events after immunization with alumimium-containing DPT vaccines: systematic review of the evidence
    • Jefferson T., Rudin M., and Pietrantonj S D. Adverse events after immunization with alumimium-containing DPT vaccines: systematic review of the evidence. Lancet 4 (2004) 84-90
    • (2004) Lancet , vol.4 , pp. 84-90
    • Jefferson, T.1    Rudin, M.2    Pietrantonj S, D.3
  • 4
    • 0033020026 scopus 로고    scopus 로고
    • An evaluation of the safety and immunogenicity of a five-component acellular pertusssis, diphtheria, and tetanus toxoid vaccine (DTaP) when combined with a Haemophilus influenzae Type b-Tetanus Toxoid conjugate vaccine (PRP-T) in Taiwanese infants
    • Lee C.Y., Thipphawong J., Huang L.M., Lee P.I., Chiu H.H., Lin W., et al. An evaluation of the safety and immunogenicity of a five-component acellular pertusssis, diphtheria, and tetanus toxoid vaccine (DTaP) when combined with a Haemophilus influenzae Type b-Tetanus Toxoid conjugate vaccine (PRP-T) in Taiwanese infants. Pediatrics 103 (1999) 25-30
    • (1999) Pediatrics , vol.103 , pp. 25-30
    • Lee, C.Y.1    Thipphawong, J.2    Huang, L.M.3    Lee, P.I.4    Chiu, H.H.5    Lin, W.6
  • 5
    • 0032053996 scopus 로고    scopus 로고
    • Safety and immunogenicity of a combined five-component pertussis-diphtheria-tetanus-inactivated poliomyelitis-Haemophilus b conjugate vaccine administered to infants at two, four, six months of age
    • Mills E., Gold R., Thipphawong J., Barreto L., Guasparini R., Meekison W., et al. Safety and immunogenicity of a combined five-component pertussis-diphtheria-tetanus-inactivated poliomyelitis-Haemophilus b conjugate vaccine administered to infants at two, four, six months of age. Vaccine 16 (1998) 576-585
    • (1998) Vaccine , vol.16 , pp. 576-585
    • Mills, E.1    Gold, R.2    Thipphawong, J.3    Barreto, L.4    Guasparini, R.5    Meekison, W.6
  • 6
    • 0031880011 scopus 로고    scopus 로고
    • Immunogenicity and reactogenicity associated with an 18-month booster dose of a new diphtheria-tetanus-whole cell pertussis vaccine
    • Nolan T., Hogg G., Darcy M.A., Carlin J.B., Skeljo M., and Varigos J. Immunogenicity and reactogenicity associated with an 18-month booster dose of a new diphtheria-tetanus-whole cell pertussis vaccine. J Pediatr Child Health 34 (1998) 346-348
    • (1998) J Pediatr Child Health , vol.34 , pp. 346-348
    • Nolan, T.1    Hogg, G.2    Darcy, M.A.3    Carlin, J.B.4    Skeljo, M.5    Varigos, J.6
  • 7
    • 0030734578 scopus 로고    scopus 로고
    • A safety and immunogenicity comparison of 12 acellular pertussis vaccines and one whole-cell pertussis vaccine given as a fourth dose in 15- to 20-month-old children
    • Pichichero M.E., Deloria M.A., Rennels M.B., Anderson E.L., Edwards K.M., Decker M.D., et al. A safety and immunogenicity comparison of 12 acellular pertussis vaccines and one whole-cell pertussis vaccine given as a fourth dose in 15- to 20-month-old children. Pediatrics 100 (1997) 772-788
    • (1997) Pediatrics , vol.100 , pp. 772-788
    • Pichichero, M.E.1    Deloria, M.A.2    Rennels, M.B.3    Anderson, E.L.4    Edwards, K.M.5    Decker, M.D.6
  • 8
    • 0031547554 scopus 로고    scopus 로고
    • Adverse events after school leavers received combined tetanus and low dose diphtheria vaccine
    • Ramsay M., Joce R., and Whalley J. Adverse events after school leavers received combined tetanus and low dose diphtheria vaccine. Commun Dis Rep CDR Rev 7 (1997) R65-R67
    • (1997) Commun Dis Rep CDR Rev , vol.7
    • Ramsay, M.1    Joce, R.2    Whalley, J.3
  • 9
    • 0032411556 scopus 로고    scopus 로고
    • Comparative safety of tetanus-diphtheria toxoids booster immunization in students in Grades 6 and 9
    • Scheifele D.W., Dobson S., Kallos A., Bjornson G., and Ochnio J.J. Comparative safety of tetanus-diphtheria toxoids booster immunization in students in Grades 6 and 9. Pediatr Infect Dis J 17 (1998) 1121-1126
    • (1998) Pediatr Infect Dis J , vol.17 , pp. 1121-1126
    • Scheifele, D.W.1    Dobson, S.2    Kallos, A.3    Bjornson, G.4    Ochnio, J.J.5
  • 10
    • 8244221661 scopus 로고    scopus 로고
    • Safety and immunogenicity of a bivalent Haemophilus influenzae type b/hepatitis B vaccine in healthy infants. Hib-HB Vaccine Study Group
    • West D.J., Hesley T.M., Jonas L.C., Feeley L.K., Bird S.R., Burke P., et al. Safety and immunogenicity of a bivalent Haemophilus influenzae type b/hepatitis B vaccine in healthy infants. Hib-HB Vaccine Study Group. Pediatr Infect Dis J 16 (1997) 593-599
    • (1997) Pediatr Infect Dis J , vol.16 , pp. 593-599
    • West, D.J.1    Hesley, T.M.2    Jonas, L.C.3    Feeley, L.K.4    Bird, S.R.5    Burke, P.6
  • 11
    • 0026483854 scopus 로고
    • Clinical assessment of the safety and efficacy of an inactivated hepatitis A vaccine: rationale and summary of findings
    • 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
    • (1992) Vaccine , vol.10 , Issue.SUPPL. 1
    • Andre, F.E.1    D'Hondt, E.2    Delem, A.3    Safary, A.4
  • 12
    • 0343962559 scopus 로고    scopus 로고
    • 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
    • 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
    • (2001) Vaccine , vol.19 , pp. 367-375
    • Araujo, O.O.1    Forleo-Neto, E.2    Vespa, G.N.3    Puccini, R.F.4    Weckx, L.W.5    Carvalho, E.S.6
  • 13
    • 0034014484 scopus 로고    scopus 로고
    • A comparison of multiple regimens of pneumococcal polysaccharide-meningococcal outer membrane protein complex conjugate vaccine and pneumococcal polysaccharide vaccine in toddlers
    • 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
    • (2000) Vaccine , vol.18 , pp. 2359-2367
    • Blum, M.D.1    Dagan, R.2    Mendelman, P.M.3    Pinsk, V.4    Giordani, M.5    Li, S.6
  • 14
    • 34447262157 scopus 로고    scopus 로고
    • The development of standardized case definitions and guidelines for adverse events following immunization
    • 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
    • (2007) Vaccine , vol.25 , pp. 5671-5674
    • Kohl, K.S.1    Gidudu, J.2    Bonhoeffer, J.3    Braun, M.M.4    Michael Buettcher, M.5    Chen, R.T.6
  • 15
    • 9144239218 scopus 로고    scopus 로고
    • Nodule at injection site as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation
    • Rothstein E., 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
    • (2004) Vaccine , vol.22 , pp. 575-585
    • Rothstein, E.1
  • 16
    • 33748557849 scopus 로고    scopus 로고
    • Safety and immunogenicity of six acellular pertussis vaccines and one whole-cell pertussis vaccine given as a fifth dose in four- to six-year-old children
    • Pichichero M.E., Edwards K.M., Anderson E.L., Rennels M.B., Englund J.A., Yerg D.E., et al. Safety and immunogenicity of six acellular pertussis vaccines and one whole-cell pertussis vaccine given as a fifth dose in four- to six-year-old children. Pediatrics 105 (2000) e11
    • (2000) Pediatrics , vol.105
    • Pichichero, M.E.1    Edwards, K.M.2    Anderson, E.L.3    Rennels, M.B.4    Englund, J.A.5    Yerg, D.E.6
  • 18
    • 0030831159 scopus 로고    scopus 로고
    • Reactogenicity and immunogenicity of a booster dose of a combined diphtheria, tetanus, and tricomponent acellular pertussis vaccine at fourteen to twenty-eight months of age
    • Schmitt H.J., Beutel K., Schuind A., Knuf M., Wagner S., Muschenborn S., et al. Reactogenicity and immunogenicity of a booster dose of a combined diphtheria, tetanus, and tricomponent acellular pertussis vaccine at fourteen to twenty-eight months of age. J Pediatr 130 (1997) 616-623
    • (1997) J Pediatr , vol.130 , pp. 616-623
    • Schmitt, H.J.1    Beutel, K.2    Schuind, A.3    Knuf, M.4    Wagner, S.5    Muschenborn, S.6
  • 19
    • 0028224121 scopus 로고
    • Adverse reactions after diphtheria-tetanus booster in 10-year-old schoolchildren in relation to the type of vaccine given for the primary vaccination
    • Blennow M., and Granström A. Adverse reactions after diphtheria-tetanus booster in 10-year-old schoolchildren in relation to the type of vaccine given for the primary vaccination. Vaccine 12 (1994) 427-430
    • (1994) Vaccine , vol.12 , pp. 427-430
    • Blennow, M.1    Granström, A.2
  • 20
    • 34447263975 scopus 로고    scopus 로고
    • 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].
  • 21
    • 34447272149 scopus 로고    scopus 로고
    • 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].
  • 22
    • 0142119235 scopus 로고    scopus 로고
    • CDC. Guidelines for maintaining and managing the vaccine cold chain. MMWR 2003;52:1023-5. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5242a6.htm [Last accessed January, 26, 2007].
  • 23
    • 39049175106 scopus 로고    scopus 로고
    • CDC. General Recommendations on Immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006;55(RR 15):1-48. Also available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5515a1.htm [Last accessed January, 26, 2007].
  • 24
    • 0034680494 scopus 로고    scopus 로고
    • CDC. Use of diphtheria toxoid-tetanus toxoid-acellular pertussis vaccine as a five-dose series. Supplemental recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2000;49(RR13):1-8.
  • 25
    • 0035906308 scopus 로고    scopus 로고
    • The CONSORT statement, revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001; 285(15):1987-91. Available on the world wide web: http://www.consort-statement.org/Statement/revisedstatement.htm [last accessed February 9, 2006].
  • 26
    • 0033610734 scopus 로고    scopus 로고
    • Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses. Lancet 1999;354(November (9193)):1896-900. Available on the world wide web: http://www.consort-statement.org/Initiatives/complements.htm [last accessed February 9, 2006].
  • 27
    • 0034685429 scopus 로고    scopus 로고
    • Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, Moher D, Becker BJ, Sipe TA, Thacker SB. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis of Observational Studies in Epidemiology (MOOSE) group. JAMA 2000; 283(15):2008-12. Available on the world wide web: http://www.consort-statement.org/Initiatives/complements.htm [last accessed February 9, 2006].


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.