Human papillomavirus vaccine in boys: background rates of potential adverse events

Hazel Clothier, Katherine Lee, Vijaya Sundararajan, James Peter Buttery, Nigel Crawford

Research output: Contribution to journalArticleResearchpeer-review

Abstract

To determine background rates of potential adverse events following immunisation (AEFI) before expansion of the quadrivalent human papillomavirus (4vHPV) vaccination program to adolescent boys. Design, patients and setting: Retrospective analysis of hospital discharge data obtained from the Victorian Admitted Episodes Dataset and emergency department visit data obtained from the Victorian Emergency Minimum Dataset for boys aged 12 to <16 years during the period 1 July 2004 to 30 June 2009. Main outcome measures: Numbers of and incidence rates for Guillain-Barr syndrome, anaphylaxis, seizures, syncope and other potential AEFI from 1 July 2004 to 30 June 2009, and estimated numbers of events after 4vHPV vaccination assuming no association (other than temporal) with the vaccine. Results: We estimated background rates of neurological and allergic events in adolescent boys to be 252.9 and 175.2 per 100 000 person-years, respectively. Assuming an 80 vaccination rate with three doses per person - which equates to 1 440 000 doses administered nationally per year in the first 2 years of the program - about 2.4 episodes of Guillain-Barr syndrome would be expected to occur in the 6 weeks following vaccination. Within 1 day of vaccination, about 3.9 seizures, 0.3 episodes of anaphylaxis and 6.5 acute allergy presentations would be expected. Conclusions: Routinely collected health outcome administration data can inform postlicensure safety surveillance of target conditions that might be perceived as AEFI.
Original languageEnglish
Pages (from-to)554 - 558
Number of pages5
JournalMedical Journal of Australia
Volume198
Issue number10
DOIs
Publication statusPublished - 2013

Cite this

Clothier, Hazel ; Lee, Katherine ; Sundararajan, Vijaya ; Buttery, James Peter ; Crawford, Nigel. / Human papillomavirus vaccine in boys: background rates of potential adverse events. In: Medical Journal of Australia. 2013 ; Vol. 198, No. 10. pp. 554 - 558.
@article{2cb7f459864a46fb8a84c332f5db43d2,
title = "Human papillomavirus vaccine in boys: background rates of potential adverse events",
abstract = "To determine background rates of potential adverse events following immunisation (AEFI) before expansion of the quadrivalent human papillomavirus (4vHPV) vaccination program to adolescent boys. Design, patients and setting: Retrospective analysis of hospital discharge data obtained from the Victorian Admitted Episodes Dataset and emergency department visit data obtained from the Victorian Emergency Minimum Dataset for boys aged 12 to <16 years during the period 1 July 2004 to 30 June 2009. Main outcome measures: Numbers of and incidence rates for Guillain-Barr syndrome, anaphylaxis, seizures, syncope and other potential AEFI from 1 July 2004 to 30 June 2009, and estimated numbers of events after 4vHPV vaccination assuming no association (other than temporal) with the vaccine. Results: We estimated background rates of neurological and allergic events in adolescent boys to be 252.9 and 175.2 per 100 000 person-years, respectively. Assuming an 80 vaccination rate with three doses per person - which equates to 1 440 000 doses administered nationally per year in the first 2 years of the program - about 2.4 episodes of Guillain-Barr syndrome would be expected to occur in the 6 weeks following vaccination. Within 1 day of vaccination, about 3.9 seizures, 0.3 episodes of anaphylaxis and 6.5 acute allergy presentations would be expected. Conclusions: Routinely collected health outcome administration data can inform postlicensure safety surveillance of target conditions that might be perceived as AEFI.",
author = "Hazel Clothier and Katherine Lee and Vijaya Sundararajan and Buttery, {James Peter} and Nigel Crawford",
year = "2013",
doi = "10.5694/mja12.1175",
language = "English",
volume = "198",
pages = "554 -- 558",
journal = "Medical Journal of Australia",
issn = "0025-729X",
publisher = "AMPCo",
number = "10",

}

Human papillomavirus vaccine in boys: background rates of potential adverse events. / Clothier, Hazel; Lee, Katherine; Sundararajan, Vijaya; Buttery, James Peter; Crawford, Nigel.

In: Medical Journal of Australia, Vol. 198, No. 10, 2013, p. 554 - 558.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Human papillomavirus vaccine in boys: background rates of potential adverse events

AU - Clothier, Hazel

AU - Lee, Katherine

AU - Sundararajan, Vijaya

AU - Buttery, James Peter

AU - Crawford, Nigel

PY - 2013

Y1 - 2013

N2 - To determine background rates of potential adverse events following immunisation (AEFI) before expansion of the quadrivalent human papillomavirus (4vHPV) vaccination program to adolescent boys. Design, patients and setting: Retrospective analysis of hospital discharge data obtained from the Victorian Admitted Episodes Dataset and emergency department visit data obtained from the Victorian Emergency Minimum Dataset for boys aged 12 to <16 years during the period 1 July 2004 to 30 June 2009. Main outcome measures: Numbers of and incidence rates for Guillain-Barr syndrome, anaphylaxis, seizures, syncope and other potential AEFI from 1 July 2004 to 30 June 2009, and estimated numbers of events after 4vHPV vaccination assuming no association (other than temporal) with the vaccine. Results: We estimated background rates of neurological and allergic events in adolescent boys to be 252.9 and 175.2 per 100 000 person-years, respectively. Assuming an 80 vaccination rate with three doses per person - which equates to 1 440 000 doses administered nationally per year in the first 2 years of the program - about 2.4 episodes of Guillain-Barr syndrome would be expected to occur in the 6 weeks following vaccination. Within 1 day of vaccination, about 3.9 seizures, 0.3 episodes of anaphylaxis and 6.5 acute allergy presentations would be expected. Conclusions: Routinely collected health outcome administration data can inform postlicensure safety surveillance of target conditions that might be perceived as AEFI.

AB - To determine background rates of potential adverse events following immunisation (AEFI) before expansion of the quadrivalent human papillomavirus (4vHPV) vaccination program to adolescent boys. Design, patients and setting: Retrospective analysis of hospital discharge data obtained from the Victorian Admitted Episodes Dataset and emergency department visit data obtained from the Victorian Emergency Minimum Dataset for boys aged 12 to <16 years during the period 1 July 2004 to 30 June 2009. Main outcome measures: Numbers of and incidence rates for Guillain-Barr syndrome, anaphylaxis, seizures, syncope and other potential AEFI from 1 July 2004 to 30 June 2009, and estimated numbers of events after 4vHPV vaccination assuming no association (other than temporal) with the vaccine. Results: We estimated background rates of neurological and allergic events in adolescent boys to be 252.9 and 175.2 per 100 000 person-years, respectively. Assuming an 80 vaccination rate with three doses per person - which equates to 1 440 000 doses administered nationally per year in the first 2 years of the program - about 2.4 episodes of Guillain-Barr syndrome would be expected to occur in the 6 weeks following vaccination. Within 1 day of vaccination, about 3.9 seizures, 0.3 episodes of anaphylaxis and 6.5 acute allergy presentations would be expected. Conclusions: Routinely collected health outcome administration data can inform postlicensure safety surveillance of target conditions that might be perceived as AEFI.

UR - http://www.ncbi.nlm.nih.gov/pubmed/23725271

U2 - 10.5694/mja12.1175

DO - 10.5694/mja12.1175

M3 - Article

VL - 198

SP - 554

EP - 558

JO - Medical Journal of Australia

JF - Medical Journal of Australia

SN - 0025-729X

IS - 10

ER -