메뉴 건너뛰기




Volumn 23, Issue 5, 2014, Pages 456-465

Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: More than 4years of experience

Author keywords

Adverse drug reactions; AS04; Human papillomavirus vaccine; Pharmacoepidemiology; Post licensure surveillance; Potential immune mediated diseases; Pregnancy

Indexed keywords

WART VIRUS VACCINE; HUMAN PAPILLOMAVIRUS VACCINE, L1 TYPE 16, 18; IMMUNOLOGICAL ADJUVANT;

EID: 84898040343     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3593     Document Type: Review
Times cited : (77)

References (39)
  • 2
    • 84898051970 scopus 로고    scopus 로고
    • Medical Dictionary for Regulatory Activities Maintenance and Support Services Organization. (accessed 21 November 2012).
    • Medical Dictionary for Regulatory Activities Maintenance and Support Services Organization. 2012. http://www.meddramsso.com/ (accessed 21 November 2012).
    • (2012)
  • 3
    • 84898031000 scopus 로고    scopus 로고
    • Report of CIOMS Working Group IV. Benefit-risk balance for marketed drugs: evaluating safety signals. (accessed 21 November 2012).
    • Report of CIOMS Working Group IV. Benefit-risk balance for marketed drugs: evaluating safety signals. 1998. http://www.cioms.ch/publications/g4-benefit-risk.pdf (accessed 21 November 2012).
    • (1998)
  • 4
    • 58149112511 scopus 로고    scopus 로고
    • Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines
    • Verstraeten T, Descamps D, David M-P, et al. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine 2008; 26: 6630-6638.
    • (2008) Vaccine , vol.26 , pp. 6630-6638
    • Verstraeten, T.1    Descamps, D.2    David, M.-P.3
  • 5
    • 84898053566 scopus 로고    scopus 로고
    • Cervarix Summary of Product Characteristics. (accessed 21 November 2012).
    • Cervarix Summary of Product Characteristics. 2012. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000721/human_med_000694.jsp&mid=WC0b01ac058001d124 (accessed 21 November 2012).
    • (2012)
  • 6
    • 84898024667 scopus 로고    scopus 로고
    • Pooled analysis of large and long-term safety data from the human papillomavirus (HPV)-16/18-AS04-adjuvanted vaccine clinical trial programme (in press).
    • Angelo M-G, David M-P, Zima J, et al. Pooled analysis of large and long-term safety data from the human papillomavirus (HPV)-16/18-AS04-adjuvanted vaccine clinical trial programme (in press).
    • Angelo, M.-G.1    David, M.-P.2    Zima, J.3
  • 7
    • 0030826946 scopus 로고    scopus 로고
    • Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union. The European Pharmacovigilance Research Group
    • Belton KJ. Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union. The European Pharmacovigilance Research Group. Eur J Clin Pharmacol 1997; 52: 423-427.
    • (1997) Eur J Clin Pharmacol , vol.52 , pp. 423-427
    • Belton, K.J.1
  • 8
    • 0032796942 scopus 로고    scopus 로고
    • Impact of geographic and cross-cultural differences on spontaneous adverse events reporting
    • Wu H, Fung M, Hornbuckle K, Muniz E. Impact of geographic and cross-cultural differences on spontaneous adverse events reporting. Drug Inf J 1999; 33: 921-931.
    • (1999) Drug Inf J , vol.33 , pp. 921-931
    • Wu, H.1    Fung, M.2    Hornbuckle, K.3    Muniz, E.4
  • 9
    • 84898051502 scopus 로고    scopus 로고
    • Medicines and Healthcare products Regulatory Agency (MHRA). Public assessment report. Cervarix (HPV vaccine): update on UK safety experience at the end of 4years use in the HPV routine immunisation programme. December. (accessed 17 January 2013).
    • Medicines and Healthcare products Regulatory Agency (MHRA). Public assessment report. Cervarix (HPV vaccine): update on UK safety experience at the end of 4years use in the HPV routine immunisation programme. December 2012. http://www.mhra.gov.uk/PrintPreview/DefaultSplashPP/CON023340?ResultCount=10&DynamicListQuery=&DynamicListSortBy=xCreationDate&DynamicListSortOrder=Desc&DynamicListTitle=&PageNumber=1&Title=Human%20papillomavirus%20(HPV)%20vaccine (accessed 17 January 2013).
    • (2012)
  • 10
    • 84855732950 scopus 로고    scopus 로고
    • Safety and tolerability of bivalent HPV vaccine: an Italian post-licensure study
    • Gasparini R, Bonanni P, Levi M, et al. Safety and tolerability of bivalent HPV vaccine: an Italian post-licensure study. Hum Vaccin 2011; 7(Suppl): 136-146.
    • (2011) Hum Vaccin , vol.7 , Issue.Suppl , pp. 136-146
    • Gasparini, R.1    Bonanni, P.2    Levi, M.3
  • 11
    • 84898049222 scopus 로고    scopus 로고
    • Adverse events following vaccination against human papillomavirus: results of the 2010 campaign in the Netherlands. (accessed 10 September 2012).
    • van't Klooster T, Kemmeren J, Vermeer-de-Bondt P, et al. Adverse events following vaccination against human papillomavirus: results of the 2010 campaign in the Netherlands. 2011. http://www.rivm.nl/en/Library/Scientific/Reports/2011/december/Adverse_events_following_vaccination_against_human_papillomavirus_Results_of_the_2010_campaign_in_the_Netherlands?sp=cml2bXE9ZmFsc2U7c2VhcmNoYmFzZT01OTAzMDtyaXZtcT1mYWxzZTs=&pagenr=5904 (accessed 10 September 2012).
    • (2011)
    • van't Klooster, T.1    Kemmeren, J.2    Vermeer-de-Bondt, P.3
  • 12
    • 1642452627 scopus 로고    scopus 로고
    • Standardized case definitions of adverse events following immunization (AEFI)
    • Bonhoeffer J, Heininger U, Kohl K, et al. Standardized case definitions of adverse events following immunization (AEFI). Vaccine 2004; 22: 547-550.
    • (2004) Vaccine , vol.22 , pp. 547-550
    • Bonhoeffer, J.1    Heininger, U.2    Kohl, K.3
  • 13
    • 31844443695 scopus 로고
    • The environment and disease: association or causation?
    • Hill AB. The environment and disease: association or causation? Proc R Soc Med 1965; 58: 295-300.
    • (1965) Proc R Soc Med , vol.58 , pp. 295-300
    • Hill, A.B.1
  • 14
    • 84875246575 scopus 로고    scopus 로고
    • Optimal approaches to data collection and analysis of potential immune mediated disorders in clinical trials of new vaccines
    • Tavares da Silva F, De Keyser F, Lambert P-H, et al. Optimal approaches to data collection and analysis of potential immune mediated disorders in clinical trials of new vaccines. Vaccine 2013; 31(14): 1870-1876.
    • (2013) Vaccine , vol.31 , Issue.14 , pp. 1870-1876
    • Tavares da Silva, F.1    De Keyser, F.2    Lambert, P.-H.3
  • 15
    • 0036388346 scopus 로고    scopus 로고
    • The epidemiology and treatment of Bell's palsy in the UK
    • Rowlands S, Hooper R, Hughes R, Burney P. The epidemiology and treatment of Bell's palsy in the UK. Eur J Neurol 2002; 9: 63-67.
    • (2002) Eur J Neurol , vol.9 , pp. 63-67
    • Rowlands, S.1    Hooper, R.2    Hughes, R.3    Burney, P.4
  • 16
    • 33745663980 scopus 로고    scopus 로고
    • No association between immunization and Guillain-Barré syndrome in the United Kingdom, 1992 to 2000
    • Hughes RA, Charlton J, Latinovic R, Gulliford MC. No association between immunization and Guillain-Barré syndrome in the United Kingdom, 1992 to 2000. Arch Intern Med 2006; 166: 1301-1304.
    • (2006) Arch Intern Med , vol.166 , pp. 1301-1304
    • Hughes, R.A.1    Charlton, J.2    Latinovic, R.3    Gulliford, M.C.4
  • 17
    • 78650518801 scopus 로고    scopus 로고
    • Guillain-Barré syndrome and Fisher syndrome: case definitions and guidelines for collection, analysis, and presentation of immunization safety data
    • Sejvar JJ, Kohl KS, Gidudu J, et al. Guillain-Barré syndrome and Fisher syndrome: case definitions and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine 2011; 29: 599-612.
    • (2011) Vaccine , vol.29 , pp. 599-612
    • Sejvar, J.J.1    Kohl, K.S.2    Gidudu, J.3
  • 18
    • 36749010976 scopus 로고    scopus 로고
    • Human papilloma virus immunization in adolescent and young adults: a cohort study to illustrate what events might be mistaken for adverse reactions
    • Siegrist C-A, Lewis EM, Eskola J, Evans SJW, Black SB. Human papilloma virus immunization in adolescent and young adults: a cohort study to illustrate what events might be mistaken for adverse reactions. Pediatr Infect Dis J 2007; 26: 979-984.
    • (2007) Pediatr Infect Dis J , vol.26 , pp. 979-984
    • Siegrist, C.-A.1    Lewis, E.M.2    Eskola, J.3    Evans, S.J.W.4    Black, S.B.5
  • 19
    • 9444264263 scopus 로고    scopus 로고
    • Incidence and lifetime prevalence of Bell's palsy in two Sicilian municipalities. Sicilian Neuro-Epidemiologic Study (SNES) Group
    • Savettieri G, Salemi G, Rocca WA, et al. Incidence and lifetime prevalence of Bell's palsy in two Sicilian municipalities. Sicilian Neuro-Epidemiologic Study (SNES) Group. Acta Neurol Scand 1996; 94: 71-75.
    • (1996) Acta Neurol Scand , vol.94 , pp. 71-75
    • Savettieri, G.1    Salemi, G.2    Rocca, W.A.3
  • 20
    • 84898022828 scopus 로고    scopus 로고
    • European Medicines Agency (Committee for Medicinal Products for Human Use). Guideline on the exposure to medicinal products during pregnancy: need for post-authorisation data. London, EMEA
    • European Medicines Agency (Committee for Medicinal Products for Human Use). Guideline on the exposure to medicinal products during pregnancy: need for post-authorisation data. London, EMEA, 2005.
    • (2005)
  • 21
    • 84898035384 scopus 로고    scopus 로고
    • Birth defects and genetic diseases branch 6-digit code for reportable congenital anomalies. (accessed 05 Sept).
    • Birth defects and genetic diseases branch 6-digit code for reportable congenital anomalies. http://www.cdc.gov/ncbddd/birthdefects/documents/macdpcode0807.pdf (accessed 05 Sept 2013).
    • (2013)
  • 23
    • 23044494023 scopus 로고    scopus 로고
    • Risk and benefit of drug use during pregnancy
    • Bánhidy F, Lowry RB, Czeizel AE. Risk and benefit of drug use during pregnancy. Int J Med Sci 2005; 2: 100-106.
    • (2005) Int J Med Sci , vol.2 , pp. 100-106
    • Bánhidy, F.1    Lowry, R.B.2    Czeizel, A.E.3
  • 24
    • 0036056239 scopus 로고    scopus 로고
    • Medical genetics: 1. Clinical teratology in the age of genomics
    • Polifka JE, Friedman JM. Medical genetics: 1. Clinical teratology in the age of genomics. CMAJ 2002; 167: 265-273.
    • (2002) CMAJ , vol.167 , pp. 265-273
    • Polifka, J.E.1    Friedman, J.M.2
  • 25
    • 79952058211 scopus 로고    scopus 로고
    • The prevalence of congenital anomalies in Europe
    • Dolk H, Loane M, Garne E. The prevalence of congenital anomalies in Europe. Adv Exp Med Biol 2010; 686: 349-364.
    • (2010) Adv Exp Med Biol , vol.686 , pp. 349-364
    • Dolk, H.1    Loane, M.2    Garne, E.3
  • 27
    • 0033151938 scopus 로고    scopus 로고
    • Estimates of the annual number of clinically recognized pregnancies in the United States, 1981-1991
    • Saraiya M, Berg CJ, Shulman H, Green CA, Atrash HK. Estimates of the annual number of clinically recognized pregnancies in the United States, 1981-1991. Am J Epidemiol 1999; 149: 1025-1029.
    • (1999) Am J Epidemiol , vol.149 , pp. 1025-1029
    • Saraiya, M.1    Berg, C.J.2    Shulman, H.3    Green, C.A.4    Atrash, H.K.5
  • 28
    • 0034960666 scopus 로고    scopus 로고
    • Design or accident? The natural history of teenage pregnancy
    • Seamark C. Design or accident? The natural history of teenage pregnancy. J R Soc Med 2001; 94: 282-285.
    • (2001) J R Soc Med , vol.94 , pp. 282-285
    • Seamark, C.1
  • 30
    • 75749097315 scopus 로고    scopus 로고
    • The identification of pregnancies within the general practice research database
    • Devine S, West S, Andrews E, et al. The identification of pregnancies within the general practice research database. Pharmacoepidemiol Drug Saf 2010; 19: 45-50.
    • (2010) Pharmacoepidemiol Drug Saf , vol.19 , pp. 45-50
    • Devine, S.1    West, S.2    Andrews, E.3
  • 31
    • 84898042743 scopus 로고    scopus 로고
    • The current state of introduction of human papillomavirus vaccination into national immunisation schedules in Europe: first results of the VENICE2 2010 survey. (accessed 7 September 2012).
    • The current state of introduction of human papillomavirus vaccination into national immunisation schedules in Europe: first results of the VENICE2 2010 survey. 2010. http://www.eurosurveillance.org/viewarticle.aspx?ArticleId=19730 (accessed 7 September 2012).
    • (2010)
  • 32
    • 84898034453 scopus 로고    scopus 로고
    • Medicines and Healthcare products Regulatory Agency (MHRA). MHRA Public Assessment Report. Cervarix (HPV vaccine): update on UK safety covering the first two years of the HPV immunisation programme. October. (accessed 7 September 2012).
    • Medicines and Healthcare products Regulatory Agency (MHRA). MHRA Public Assessment Report. Cervarix (HPV vaccine): update on UK safety covering the first two years of the HPV immunisation programme. October 2010. http://www.mhra.gov.uk/PrintPreview/DefaultSplashPP/CON023340?ResultCount=10&DynamicListQuery=&DynamicListSortBy=xCreationDate&DynamicListSortOrder=Desc&DynamicListTitle=&PageNumber=1&Title=Human%20papillomavirus%20(HPV)%20vaccine (accessed 7 September 2012).
    • (2010)
  • 33
    • 84898040327 scopus 로고    scopus 로고
    • Medicines and Healthcare products Regulatory Agency (MHRA). YellowCard. Helping to make medicines safer. (accessed 17 January 2012).
    • Medicines and Healthcare products Regulatory Agency (MHRA). YellowCard. Helping to make medicines safer. 2012. http://yellowcard.mhra.gov.uk/ (accessed 17 January 2012).
    • (2012)
  • 34
    • 84898045532 scopus 로고    scopus 로고
    • Medicines and Healthcare products Regulatory Agency (MHRA). Human papillomavirus (HPV) vaccine. (accessed 17 January).
    • Medicines and Healthcare products Regulatory Agency (MHRA). Human papillomavirus (HPV) vaccine. http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Product-specificinformationandadvice/Product-specificinformationandadvice-G-L/HumanpapillomavirusHPVvaccine/index.htm (accessed 17 January 2013).
    • (2013)
  • 36
    • 0032417803 scopus 로고    scopus 로고
    • Limitations and strengths of spontaneous reports data
    • Goldman SA. Limitations and strengths of spontaneous reports data. Clin Ther 1998; 20: C40-C44.
    • (1998) Clin Ther , vol.20
    • Goldman, S.A.1
  • 37
    • 84881054008 scopus 로고    scopus 로고
    • Global Advisory Committee on Vaccine Safety
    • Global Advisory Committee on Vaccine Safety. Wkly Epidemiol Rec 2013; 88: 301-312.
    • (2013) Wkly Epidemiol Rec , vol.88 , pp. 301-312
  • 38
    • 34447287275 scopus 로고    scopus 로고
    • Encephalitis, myelitis, and acute disseminated encephalomyelitis (ADEM): case definitions and guidelines for collection, analysis, and presentation of immunization safety data
    • Sejvar JJ, Kohl KS, Bilynsky R, et al. Encephalitis, myelitis, and acute disseminated encephalomyelitis (ADEM): case definitions and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine 2007; 25: 5771-5792.
    • (2007) Vaccine , vol.25 , pp. 5771-5792
    • Sejvar, J.J.1    Kohl, K.S.2    Bilynsky, R.3
  • 39
    • 0034955141 scopus 로고    scopus 로고
    • Recommended diagnostic criteria for multiple sclerosis: guidelines from the international panel on the diagnosis of multiple sclerosis
    • McDonald WI, Compston A, Edan G, et al. Recommended diagnostic criteria for multiple sclerosis: guidelines from the international panel on the diagnosis of multiple sclerosis. Ann Neurol 2001; 50: 121-127.
    • (2001) Ann Neurol , vol.50 , pp. 121-127
    • McDonald, W.I.1    Compston, A.2    Edan, G.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.