메뉴 건너뛰기




Volumn 33, Issue 47, 2015, Pages 6441-6452

Key terms for the assessment of the safety of vaccines in pregnancy: Results of a global consultative process to initiate harmonization of adverse event definitions

Author keywords

AEFI; Brighton; Maternal immunization; Pregnancy; Safety; Vaccines

Indexed keywords

INFLUENZA VACCINE; VACCINE; YELLOW FEVER VACCINE;

EID: 84947996250     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2015.07.112     Document Type: Article
Times cited : (39)

References (65)
  • 1
    • 84876869957 scopus 로고    scopus 로고
    • Maternal immunization as a strategy to decrease susceptibility to infection in newborn infants
    • Lindsey B., Kampmann B., Jones C. Maternal immunization as a strategy to decrease susceptibility to infection in newborn infants. Curr Opin Infect Dis 2013, 26:248-253.
    • (2013) Curr Opin Infect Dis , vol.26 , pp. 248-253
    • Lindsey, B.1    Kampmann, B.2    Jones, C.3
  • 3
    • 77955701149 scopus 로고    scopus 로고
    • Prevention and control of influenza with vaccines. Recommendations of the Advisory Committee on Immunization Practices (ACIP)
    • Centers for Disease Control and Prevention Prevention and control of influenza with vaccines. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2010, 59:1-62.
    • (2010) MMWR , vol.59 , pp. 1-62
  • 4
    • 84947977858 scopus 로고    scopus 로고
    • Influenza
    • (chapter 19)
    • Public Health England Influenza. The green book 2012, Available at: 〈https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/224775/JCVI-statement-on-the-annual-influenza-vaccination-programme-25-July-2012.pdf〉 (chapter 19).
    • (2012) The green book
  • 5
    • 84874399277 scopus 로고    scopus 로고
    • Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant women-ACIP 2012
    • Advisory Committee on Immunization Practices (ACIP) Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant women-ACIP 2012. MMWR 2013, 62(Feb (7)):131-135.
    • (2013) MMWR , vol.62 , Issue.Feb 7 , pp. 131-135
  • 6
    • 84908326821 scopus 로고    scopus 로고
    • Effectiveness of maternal pertussis vaccination in England: an observational study
    • Oct 25
    • Amirthalingam G., Andrews N., Campbell H., Ribeiro S., Kara E., Donegan K., et al. Effectiveness of maternal pertussis vaccination in England: an observational study. Lancet 2014, 384(9953):1521-1528. Oct 25.
    • (2014) Lancet , vol.384 , Issue.9953 , pp. 1521-1528
    • Amirthalingam, G.1    Andrews, N.2    Campbell, H.3    Ribeiro, S.4    Kara, E.5    Donegan, K.6
  • 7
    • 75849124774 scopus 로고    scopus 로고
    • National Institutes of Health, (accessed March 21, 2015)
    • National Institutes of Health Clinical trials 2015, National Institutes of Health, Available at 〈http://www.clinicaltrials.org〉 (accessed March 21, 2015).
    • (2015) Clinical trials
  • 8
    • 1642452627 scopus 로고    scopus 로고
    • Standardized case definitions of adverse events following immunization (AEFI)
    • The Brighton Collaboration
    • Bonhoeffer J., Kohl K., Chen R.T., Duclos P., Heijbel H., Heininger H., et al. Standardized case definitions of adverse events following immunization (AEFI). Vaccine 2004, 22:547-550. The Brighton Collaboration.
    • (2004) Vaccine , vol.22 , pp. 547-550
    • Bonhoeffer, J.1    Kohl, K.2    Chen, R.T.3    Duclos, P.4    Heijbel, H.5    Heininger, H.6
  • 9
    • 85018046181 scopus 로고    scopus 로고
    • Brighton Collaboration Guidelines for Data collection in Maternal and Neonatal Vaccine Trials. 〈https://brightoncollaboration.org/public/what-we-do/setting-standards/guidelines.html〉.
  • 10
    • 84882970016 scopus 로고    scopus 로고
    • Research on vaccines and antimicrobials during pregnancy: challenges and opportunities
    • Beigi R.H., Goldkind S.F., Jevaji I. Research on vaccines and antimicrobials during pregnancy: challenges and opportunities. Vaccine 2013, 31:4261-4263.
    • (2013) Vaccine , vol.31 , pp. 4261-4263
    • Beigi, R.H.1    Goldkind, S.F.2    Jevaji, I.3
  • 11
    • 84882953409 scopus 로고    scopus 로고
    • Research on vaccines during pregnancy: protocol design and assessment of safety
    • Munoz F.M., Sheffield J.S., Beigi R.H., et al. Research on vaccines during pregnancy: protocol design and assessment of safety. Vaccine 2013, 31:4274-4279.
    • (2013) Vaccine , vol.31 , pp. 4274-4279
    • Munoz, F.M.1    Sheffield, J.S.2    Beigi, R.H.3
  • 12
    • 84882882133 scopus 로고    scopus 로고
    • Research on vaccines during pregnancy: reference values for vital signs and laboratory assessments
    • Sheffield J.S., Munoz F.M., Beigi R.H., et al. Research on vaccines during pregnancy: reference values for vital signs and laboratory assessments. Vaccine 2013, 31:4264-4273.
    • (2013) Vaccine , vol.31 , pp. 4264-4273
    • Sheffield, J.S.1    Munoz, F.M.2    Beigi, R.H.3
  • 13
    • 84979863753 scopus 로고    scopus 로고
    • Assessment of safety in newborns of mothers participating in clinical trials of vaccines administered during pregnancy
    • Munoz F.M., Weisman L.E., Read J.S., Siberry G., Kotloff K., Friedman J., et al. Assessment of safety in newborns of mothers participating in clinical trials of vaccines administered during pregnancy. Clin Infect Dis 2014, 59(S7):S415-S428.
    • (2014) Clin Infect Dis , vol.59 , pp. S415-S428
    • Munoz, F.M.1    Weisman, L.E.2    Read, J.S.3    Siberry, G.4    Kotloff, K.5    Friedman, J.6
  • 15
    • 84947927461 scopus 로고    scopus 로고
    • Vaccines against influenza WHO position paper - November 2012, WER No. 47
    • World Health Organization Weekly Epidemiological Record, Vaccines against influenza WHO position paper - November 2012, WER No. 47, 2012, 87, 461-476, Available at: 〈http://www.who.int/wer〉.
    • (2012) , vol.87 , pp. 461-476
  • 16
    • 84893166681 scopus 로고    scopus 로고
    • Meeting of the Strategic Advisory Group of experts on immunization, November 2013-conclusions and recommendations. Vaccination of pregnant and lactating women
    • (WER No. 1)
    • World Health Organization Meeting of the Strategic Advisory Group of experts on immunization, November 2013-conclusions and recommendations. Vaccination of pregnant and lactating women. Wkly Epidemiol Rec 2014, 89:1-20. Available at: 〈http://www.who.int/wer〉 (WER No. 1).
    • (2014) Wkly Epidemiol Rec , vol.89 , pp. 1-20
  • 17
    • 84904917004 scopus 로고    scopus 로고
    • Revised guidance on the choice of pertussis vaccines: July
    • (2014)
    • World Health Organization Revised guidance on the choice of pertussis vaccines: July. Wkly Epidemiol Rec 2014, 89(Jul (30)):337-340. (2014).
    • (2014) Wkly Epidemiol Rec , vol.89 , Issue.Jul 30 , pp. 337-340
  • 18
    • 53749099143 scopus 로고    scopus 로고
    • Effectiveness of maternal influenza immunization in mothers and infants
    • Zaman K., et al. Effectiveness of maternal influenza immunization in mothers and infants. N Engl J Med 2008, 359:1155-1164.
    • (2008) N Engl J Med , vol.359 , pp. 1155-1164
    • Zaman, K.1
  • 20
    • 84947966817 scopus 로고    scopus 로고
    • A systematic review of adverse events following immunization during pregnancy and the newborn period
    • Fulton T.R., et al. A systematic review of adverse events following immunization during pregnancy and the newborn period. Vaccine 2015, 33:6453-6465.
    • (2015) Vaccine , vol.33 , pp. 6453-6465
    • Fulton, T.R.1
  • 21
    • 85018081307 scopus 로고    scopus 로고
    • WHO and Brighton Collaboration Consultative Meeting Report, available at: 〈http://www.who.int/immunization/research/meetings_workshops/brighton_keyterms_safety_pregnancy.pdf?ua=1〉.
  • 22
    • 84963764839 scopus 로고    scopus 로고
    • AE definitions
    • World Health Organization (WHO) AE definitions. Wkly Epidemiol Rep 2014, 89(1):1-20. Available at: 〈www.who.org〉.
    • (2014) Wkly Epidemiol Rep , vol.89 , Issue.1 , pp. 1-20
  • 23
    • 84947977861 scopus 로고    scopus 로고
    • Global manual on surveillance of adverse events following immunization (AEFI)
    • Feb
    • World Health Organization Global manual on surveillance of adverse events following immunization (AEFI). Draft 2.0 Feb, 2014.
    • (2014) Draft 2.0
  • 24
    • 84881054008 scopus 로고    scopus 로고
    • The safety of immunization during pregnancy
    • (June 2013, no. 29)
    • Global Advisory Committee on Vaccine Safety The safety of immunization during pregnancy. Wkly Epidemiol Rep 2013, 88(July):301-312. (June 2013, no. 29).
    • (2013) Wkly Epidemiol Rep , vol.88 , Issue.July , pp. 301-312
  • 25
    • 84947923898 scopus 로고    scopus 로고
    • Family and community health, WHO.
    • World Health Organization, Department of Making Pregnancy Safer. Family and community health, WHO. 〈www.who.int/making_pregnancy_safer〉.
    • Department of Making Pregnancy Safer
  • 26
    • 84861928506 scopus 로고    scopus 로고
    • World Health Organization, Geneva, (March of Dimes, PMNCH, Save Children, WHO. Born too Soon), C.P. Howson, M.V. Kinney, J.E. Lawn (Eds.)
    • World Health Organization The global action report on preterm birth 2012, World Health Organization, Geneva, (March of Dimes, PMNCH, Save Children, WHO. Born too Soon). C.P. Howson, M.V. Kinney, J.E. Lawn (Eds.).
    • (2012) The global action report on preterm birth
  • 28
    • 77953706649 scopus 로고    scopus 로고
    • November, (accessed 29 May 2014)
    • National Institutes of Health (NIH) Division of Microbiology and Infectious Diseases (DMID) Pediatric toxicity tables. Draft November, 2007, 〈http://www.niaid.nih.gov/LabsAndResources/resources/DMIDClinRsrch/Documents/dmidpedtox.pdf〉 (accessed 29 May 2014).
    • (2007) Pediatric toxicity tables. Draft
  • 29
    • 84947977862 scopus 로고    scopus 로고
    • (accessed July, 2014).
    • National Children Study Terminology, 2014. available at: 〈http://evs.nci.nih.gov/ftp1/nichd/〉 (accessed July, 2014).
    • (2014)
  • 30
    • 84947977863 scopus 로고    scopus 로고
    • (accessed 29 May 2014)
    • NICHD Maternal-fetal medicine units (MFMU) network 2014, Available at: 〈https://www.nichd.nih.gov/research/supported/Pages/mfmu.aspx〉 (accessed 29 May 2014).
    • (2014) Maternal-fetal medicine units (MFMU) network
  • 31
    • 84947932660 scopus 로고    scopus 로고
    • (accessed 29 May 2014)
    • Research Triangle Institute, NICHD Neonatal research network 2014, Available at: 〈https://neonatal.rti.org/about/network.cfm〉 (accessed 29 May 2014).
    • (2014) Neonatal research network
  • 33
    • 84947941808 scopus 로고    scopus 로고
    • (Accessed 02 June 2014)
    • GAVI Alliance GAVI's mission 2014, Available at: 〈http://www.gavialliance.org/about/mission/〉 (Accessed 02 June 2014).
    • (2014) GAVI's mission
  • 34
    • 84947977865 scopus 로고    scopus 로고
    • (accessed 02 June 2014)
    • UNICEF United States fund 2014, Available at: 〈http://www.unicefusa.org/〉 (accessed 02 June 2014).
    • (2014) United States fund
  • 35
    • 84947920106 scopus 로고    scopus 로고
    • (accessed 02 June 2014)
    • World Health Organization (WHO) Health topics: maternal health 2014, Available at: 〈http://www.who.int/topics/maternal_health/en/〉 (accessed 02 June 2014).
    • (2014) Health topics: maternal health
  • 36
    • 84877880647 scopus 로고    scopus 로고
    • Moving beyond essential interventions for reduction of maternal mortality (the WHO Multicountry survey on maternal and newborn health): a cross sectional study
    • Souza J.P., Gulmezoglu A.M., Vogel J., Carroli G., Lumbiganon P., Qureshi Z., et al. Moving beyond essential interventions for reduction of maternal mortality (the WHO Multicountry survey on maternal and newborn health): a cross sectional study. Lancet 2013, 381:1747-1755.
    • (2013) Lancet , vol.381 , pp. 1747-1755
    • Souza, J.P.1    Gulmezoglu, A.M.2    Vogel, J.3    Carroli, G.4    Lumbiganon, P.5    Qureshi, Z.6
  • 37
    • 84908126481 scopus 로고    scopus 로고
    • Global, regional, and national levels and causes of maternal mortality during 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013
    • (epub)
    • Kasenbaum N., Bertozzi-Villa A., Coggeshall M.S., et al. Global, regional, and national levels and causes of maternal mortality during 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet 2014, 2(May):1014. (epub).
    • (2014) Lancet , vol.2 , Issue.May , pp. 1014
    • Kasenbaum, N.1    Bertozzi-Villa, A.2    Coggeshall, M.S.3
  • 38
    • 84871036375 scopus 로고    scopus 로고
    • Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010
    • Lozano R., Naghavi M., Foreman K., et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012, 380:2095-2128.
    • (2012) Lancet , vol.380 , pp. 2095-2128
    • Lozano, R.1    Naghavi, M.2    Foreman, K.3
  • 40
    • 77949884145 scopus 로고    scopus 로고
    • Two million intrapartum related stillbirths and neonatal deaths: where, why and what can be done?
    • Lawn J.E., Lee A.C.C., Kinney M., Sibley M., Carlo A.W., Paul V., et al. Two million intrapartum related stillbirths and neonatal deaths: where, why and what can be done?. Int J Gynecol Obstet 2009, 107:S5-S19.
    • (2009) Int J Gynecol Obstet , vol.107 , pp. S5-S19
    • Lawn, J.E.1    Lee, A.C.C.2    Kinney, M.3    Sibley, M.4    Carlo, A.W.5    Paul, V.6
  • 41
    • 84947977866 scopus 로고    scopus 로고
    • Ninth Revision, Clinical Modification (ICD-9-CM) published by the U.S. Public Health Service and Health Care Financing Administration
    • International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) published by the U.S. Public Health Service and Health Care Financing Administration, available at: 〈http://www.cms.gov/index.html〉.
  • 42
    • 84947977867 scopus 로고    scopus 로고
    • (ICD-10-CM) published by the U.S. Public Health Service and Health Care Financing Administration
    • International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) published by the U.S. Public Health Service and Health Care Financing Administration, available at: 〈http://www.cms.gov/index.html〉.
  • 43
    • 12344312699 scopus 로고    scopus 로고
    • (Published May 28, 2009 (v4.03:June 14, 2010))
    • US Department of Health and Human Services, National Institutes of Health and National Cancer Institute Common terminology criteria for adverse events (CTCAE). Version 4.0 2009, (Published May 28, 2009 (v4.03:June 14, 2010)).
    • (2009) Common terminology criteria for adverse events (CTCAE). Version 4.0
  • 45
    • 85018076959 scopus 로고    scopus 로고
    • Ester EUROCAT report: developing the surveillance of multiple congenital anomalies
    • Eurocat Garne, Ester EUROCAT report: developing the surveillance of multiple congenital anomalies 2014.
    • (2014)
  • 46
    • 85018057947 scopus 로고    scopus 로고
    • EUROCAT. Coding of Anomalies. Available at: 〈www.eurocat-network.eu/newprevdata/appendices.cgi〉.
    • Coding of Anomalies
  • 48
    • 79952682978 scopus 로고    scopus 로고
    • Paper 3. EUROCAT data quality indicators for population based registries of congenital anomalies
    • Loane M., Dolk H., Garne E., Greenlees R. Paper 3. EUROCAT data quality indicators for population based registries of congenital anomalies. Birth Defects Res (A) 2011, 91:S23-S30. EUROCAT Working Group.
    • (2011) Birth Defects Res (A) , vol.91 , pp. S23-S30
    • Loane, M.1    Dolk, H.2    Garne, E.3    Greenlees, R.4
  • 49
    • 13244273746 scopus 로고    scopus 로고
    • An etiological classification of birth defects for epidemiological research
    • Wellesley D, Boyd P, Dolk H, Pattenden S. An etiological classification of birth defects for epidemiological research. J Med Genet, Vol 42, No.1, pp 54-57. Available at: 〈http://www.eurocat.ulster.ac.uk/pubdata/〉.
    • J Med Genet , vol.42 , Issue.1 , pp. 54-57
    • Wellesley, D.1    Boyd, P.2    Dolk, H.3    Pattenden, S.4
  • 50
    • 77952717756 scopus 로고    scopus 로고
    • Metropolitan Atlanta Congenital Defects Program (MACDP) Birth defects. Available from: 〈http://www.cdc.govncbddd/birthdefects/macdp.html〉.
    • Birth defects
  • 51
    • 84885815480 scopus 로고    scopus 로고
    • National Birth Defects Prevention Network. Birth defects surveillance guidelines. Available at: 〈http://www.nbdpn.org/birth_defects_surveillance:gui.php〉.
    • Birth defects surveillance guidelines
  • 52
    • 85018052383 scopus 로고    scopus 로고
    • International Birth Defects Information Systems. Website: 〈http://www.ibis-birthdefects.org/〉.
  • 53
    • 85018081598 scopus 로고    scopus 로고
    • International Clearinghouse for Birth Defects Surveillance and Research. Website: 〈http://www.icbdsr.org〉.
  • 54
    • 84927749596 scopus 로고    scopus 로고
    • World Health Organization, Geneva
    • World Health Organization (WHO), National Center on Birth Defects and Developmental Disabilities from the United States Centers for Disease Control and Prevention (CDC), International Clearinghouse for Birth Defects Surveillance and Research (ICBDSR) Birth defects surveillance: a manual for programme managers 2014, World Health Organization, Geneva, Available at: 〈http://www.who.int/nutrition/publications/birthdefects_manual/en/〉.
    • (2014) Birth defects surveillance: a manual for programme managers
  • 55
    • 0141925970 scopus 로고    scopus 로고
    • Guidelines for case classification for the National Birth Defects Prevention Study
    • Rasmussen S.A., Olney R.S., Holmes L.B., et al. Guidelines for case classification for the National Birth Defects Prevention Study. Birth Defects Res (A) 2003, 67:193-201.
    • (2003) Birth Defects Res (A) , vol.67 , pp. 193-201
    • Rasmussen, S.A.1    Olney, R.S.2    Holmes, L.B.3
  • 56
    • 84908653179 scopus 로고    scopus 로고
    • Definition and application of terms for vaccine pharmacovigilance
    • Council for International Organizations of Medical Services (CIOMS), World Health Organization (WHO) Definition and application of terms for vaccine pharmacovigilance. Report of CIOMS/WHO working group on vaccine pharmacovigilance 2012, Available at: 〈http://whglibdoc.who.int/publications/2012/9789290360834_eng.pdf〉.
    • (2012) Report of CIOMS/WHO working group on vaccine pharmacovigilance
  • 57
    • 84947977874 scopus 로고    scopus 로고
    • Vaccine safety
    • (accessed 29 May 2014)
    • CDC Vaccine safety. Clinical immunization safety assessment (CISA) project 2014, Available at: 〈http://www.cdc.gov/vaccinesafety/activities/cisa.html〉 (accessed 29 May 2014).
    • (2014) Clinical immunization safety assessment (CISA) project
  • 58
    • 84947977875 scopus 로고    scopus 로고
    • (accessed July 24, 2015)
    • The Vaccine Adverse Event Reporting System (VAERS), 2015. Available at: 〈https://vaers.hhs.gov/index〉, (accessed July 24, 2015).
    • (2015)
  • 61
    • 84947921345 scopus 로고    scopus 로고
    • (accessed 23 July, 2014)
    • American College of Obstetrics and Gynecology Practice bulletins 2014, Available at: 〈http://www.acog.org〉 (accessed 23 July, 2014).
    • (2014) Practice bulletins
  • 62
    • 84947977876 scopus 로고    scopus 로고
    • (accessed 23 July, 2014)
    • American College of Obstetrics and Gynecology reVITALize definitions 2014, Available at: 〈http://www.ACOG.org〉, (accessed 23 July, 2014).
    • (2014) reVITALize definitions
  • 63
    • 84947977877 scopus 로고    scopus 로고
    • (accessed April 25, 2015)
    • Brighton Collaboration Resources, 2015. Website available at: 〈http://brightoncollaboration.org/public/resources/standards/case-definitions/pregnancy.html〉 (accessed April 25, 2015).
    • (2015)
  • 64
    • 84947977878 scopus 로고    scopus 로고
    • (accessed May 30, 2015)
    • GAIA Consortium Website, 2015, Available at: 〈http://gaia-consortium.net〉, (accessed May 30, 2015).
    • (2015)
  • 65
    • 84906906093 scopus 로고    scopus 로고
    • The global vaccine safety initiative: enhancing vaccine pharmacovigilance capacity at country level
    • Maure C.G., Dodoo A.N., Bonhoeffer J., Zuber P.L.F. The global vaccine safety initiative: enhancing vaccine pharmacovigilance capacity at country level. Bull World Health Organ. 2014, 92(9):695-696.
    • (2014) Bull World Health Organ. , vol.92 , Issue.9 , pp. 695-696
    • Maure, C.G.1    Dodoo, A.N.2    Bonhoeffer, J.3    Zuber, P.L.F.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.