Abstract
| Original language | English |
|---|---|
| Pages (from-to) | 554 - 558 |
| Number of pages | 5 |
| Journal | Medical Journal of Australia |
| Volume | 198 |
| Issue number | 10 |
| DOIs | |
| Publication status | Published - 2013 |
Cite this
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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 journal › Article › Research › peer-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 -