1. National Centre for Immunisation Research and Surveillance, Sydney, Australia

Transcription

1 Electronic Supplementary Material (ESM) 3 Safety of human papillomavirus s: An updated review Anastasia Phillips, 1,2 Cyra Patel, 1 Alexis Pillsbury, 1 Julia Brotherton, 3,4 Macartney 1,2 Kristine 1. National Centre for Immunisation Research and Surveillance, Sydney, Australia 2. The University of Sydney, Australia 3. National HPV Vaccination Program Register, Victoria Cytology Service, Australia 4. The University of Melbourne, Australia Corresponding author: A/Prof Kristine Macartney National Centre for Immunisation Research and Surveillance Kids Research Institute The Sydney Children's Hospitals Network Cnr Hawkesbury Road and Hainsworth Street Westmead, NSW 2145 Australia Kristine.Macartney@health.nsw.gov.au Tel

2 ESM 3: Summary of selected safety data from observational studies using population-based data sources from 10th May 2012 to 11 August 2016 Period/ Data source, Study cohort Reference study type USA Liu 2016 [1] Naleway et al 2016 [2] Yih 2016 [3] Langer- Gould 2014 [4] Baxter 2016 [5] Pellegrino 2014 [6] Macarthy et al 2016 [7] / Descriptive VSD Insurance claims data from Mini- Sentinel Data Partners/ immunisation registries, SCRI MCO Nested case control MCO Case-centred National /Kids Inpatient Sample VSD Case-centred Females > 9 yrs; n =196, 270; doses Females 9-26 yrs; n=650 Females 9-26 yrs; n= 53 Cases Females 9-26 yrs; n=92 Controls 9-26 yrs, n=459 Females with SSHL immunised up to 9 months prior Controls matched to MCO members receiving same in 9 mnths prior to onset date in case Females & males <17 yrs post-2006 vs pre-2006 Females & males 9-26yrs ( doses administered) Total 0-30 days Non-external N=34 N=4 causes All causes N=117 N=13 Any AE (first episode) or acquired CNS demyelinating syndromes up to 3yrs post vaccination 37.3 per doses administered 1-7day window: IRR = 1.47 [ ] 1-14d window: IRR = 0.97 [ ] 1-28d window: IRR 0.72 [ ] 1-60d window: IRR = 0.92 [ ] Risk window 1-28d: RR=0.7 [ ] Risk window 1-7d: RR = 0.43 [ ] OR 1.05 [ ] SSHL OR [ ] SLE Death 0-30 days after No increase in hospitalisations (data not reported) Non-external causes: RR=1.28[ ] All causes: RR=1.12 [ ]

3 Reference UK Donegan 2013 [8] Baril 2015 [9] Cameron 2016[10] Period/ v/ Scotland -12 2v/ Scotland Denmark, Sweden Arnheim- Dahlstrom 2013[11] Data source, study type CPRD CPRD CRPD Hospital admissions Date linkage /trend analysis Study cohort Females & males, vs Fatigue syndromes Females 12-20yrs: IRR = [ ] Adults 21+ yrs: IRR: 0.96 [ ] Males: IRR 0.66 [ ] Females yrs; n=187 Fatigue syndromes IRR: 1.07 [ ] (p = 0.84) Females yrs, first day gestation -30 to +45 d after any dose (exposed) vs Females yrs, first day gestation 120 d to 18 mnths after last dose(unexposed) Spontaneous abortion HR = 1.30 [ ] a No significant change in incidence in 54 Males & Females 12-18yrs; conditions conditions. Females yrs; n=12 Bell s palsy 4 of 12 cases aged 12-13yrs were vaccinated Vaccinated (n= ) vs unvaccinated females yrs; n= outcomes (AID, neurological & ), selected shown: Hashimoto s thyroiditis Hypothyroidism Crohn s disease Ulcerative colitis Juvenile arthritis SLE ITP Bell s Palsy ON Bechet s syndrome Raynaud s disease T1DM RR not significant for 20 of 23 conditions RR=1.12 [ ] RR=0.90 [ ] RR=0.85 [ ] RR=0.71 [ ] RR=0.99 [ ] RR=1.35 [ ] RR=1.18 [ ] RR=1.02 [ ] RR=0.67 [ ] RR=0.86 ( ) RR significant for 3 of 23 conditions* RR= 3.37 [ ] RR = 1.67 [ ] RR= 1.29 [ ]

4 Reference Scheller 2015 [12] Scheller 2014 [13] Netherlands Schurink- Van t Klooster [14] France Grimaldi- Bensouda 2014[15] ANSM 2015 [16] Period/ / Data source, study type database database database, PGRx programme Case control French health insurance scheme, Study cohort Vaccinated (n= ) vs unvaccinated females yrs n= ; Other n= Vaccinated females =4322 Other n=3300 Females yrs n= Males & Females yrs, vs 2008; n=321 certain b, n=127 uncertain b migraine Vaccinated (n=11) & unvaccinated (n=11) females yrs with incident migraine Vaccinated females born , n=11 Cases: Females yrs, n=211 Controls: matched, n=875 Vaccinated (n= 842,120) vs unvaccinated (n= ) females yrs ON, neuromyelitis optica, TM, ADEM ON, neuromyelitis optica, TM, ADEM IRR = 0.90 [95%CI, ] IRR = 1.00 [95%CI, ] IRR = 1.05 [95%CI, ] IRR = 1.14 [95%CI, ] IRR (adjusted for oral contraceptive use) = 0.80 [ ] Migraine IRR (certain migraine) = 1.14 [ ] Migraine Migraine AID ITP CTD T1DM AID IBD GBS IRR in monthly periods following dose 1 vs unvaccinated/pre-vaccinated ranged from (none significant) RR 6.3 [ ] adjusted for school holidays Adj OR = 0.9 [ ] OR = 1.0 ( ) OR = 0.3 ( ) OR = 0.8 ( ) OR = 1.2 ( ) HR = 1.07 [ ] HR = 1.19 [ ] HR = 4.00 [ ] Abbreviations: ADEM - acute disseminated encephalomyelitis; AID - autoimmune disease; CPRD - Clinical Practice Research Datalink; CNS - Central nervous system; CTD - connective tissue disease; d days; ICPI - GBS - Guillain Barre Syndrome; HR - hazard ratio; IBS - inflammatory bowel disease; ITP - immune thrombocytopenic purpura; Integrated Primary Care Information Database; IRR - incidence rate ratio; MCO Managed Care Organizations; mnths months; - multiple sclerosis; ON - optic neuritis; OR - Odds ratio; PGRx - Pharmacoepidemiologic General Research Extension; RR - relative risk; - Self-controlled case series; SCRI - Self-controlled risk interval; SLE - systemic lupus erythematosus; SSHL - Sudden sensorineural hearing loss; TM - transverse myelitis; T1DM - type 1 diabetes mellitus; VSD - Vaccine Safety Datalink; - Venous thromboembolism; yrs years. * Only met 1 of 3 pre-defined signal strengthening criteria; not considered to be temporally associated with vaccination a Based on Medicines and Healthcare Products Regulatory Agency listing of conditions possibly linked to HPV vaccination plus other disorders of autonomic nervous system [10] b Certain migraine was defined as patients with definite migraine and menstruation-related migraine, uncertain migraine was defined as unclear/possible migraine and typical aura without headache [14]

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