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. 2015 Sep 17;12(1):187–193. doi: 10.1080/21645515.2015.1068486

Table 1.

Summary of the design of 12 publically available studies assessing an association between pandemic AS03-adjuvanted H1N1 vaccination and narcolepsy

    Population
Case ascertainment
Vaccine ascertainment
Study Design Geographic origin (period) Size Age Source Validation Source Coverage
MPA-registry cohort, Sweden8 RC 7 counties (2009–2011) 5.8 M All Contact with hospitals and sleep labs, spontaneous reports No expert review Regional vaccination registries 60%
MPA case-inventory, Sweden5 RC Nationwide (2009–2010)   All Registers on hospitalisation and specialist care By 2 experts in neurology/sleep disorders Regional vaccination registries 60%
Stockholm county cohort, Sweden16 RC Stockholm county (1998–2010) 2 M < 20 (for narcolepsy) Hospital registers, child rehabilitation, neurophysiology centers No expert review Local vaccination registry (Vaccinera) 52.6%
Western Sweden cohort11 RC Western Swedish health care region (2000–2010) 0.4 M 2–17 yrs National and local hospital registers, register 3 specialized centers No expert review Unclear  
Finnish childhood cohort24 RC Nationwide (2009–2010) 0.9 M 4–19 yrs National hospital registers By 2 narcolepsy experts. Discrepancies adjudicated by a narcolepsy expert panel Electronic primary health care databases 75%
Finnish adult cohort25 RC Nationwide (2009–2011) 3.3 M Adults National hospital registers + direct contact pediatric neurologists By 2 narcolepsy experts. Discrepancies adjudicated by a narcolepsy expert panel Electronic primary health care databases 48%
Finnish case series10 Eco Nationwide (2002–2010)   All National care register + direct contact health care professionals By 5 experts in neurology/sleep disorders Vaccine certificates  
Irish cohort26 RC Nationwide (2009–2010) 4.2 M 4–19 yrs, ≥ 20 yrs Direct contact sleep and pediatric neurology centers By an adult and pediatric neurologist Reimbursement database and mass vaccination database 22.5%
English case-coverage9 CCo Nationwide (2008–2011) 9.1 M 4–18 yrs Direct contact sleep centers By 3 narcolepsy experts GP questionnaires 1.9%*
French case-control13 CC Nationwide (2009–2011) 65 M All Direct contact sleep centers By 2 narcolepsy experts Telephone interviews 6.3%**
VAESCO EU multi-country3 Denmark, France, Italy, the Netherlands, Norway & UK: non-signaling + Sweden & Finland CC Nationwide or regional, (April 2009-June 2010) 30 M All Varied by country - registers, direct contact with sleep centers Country dependent Variety of methods Very low to high
Norwegian cohort27 RC Nationwide (120 weeks from 2009 onwards) 1 M <20 yrs Medical institutions and practitioners By a pediatrician and expert in sleep disorders National vaccination register 50%

MPA = Medical products Agency, M = millions, RC = retrospective cohort. CS = case series, CC = case control, CCo = case coverage, Eco = ecological study,

*

37% in the 2–15 y old risk group and includes some use of unadjuvanted vaccines in pregnant women and young infants,

**

mostly 9 y of age and older.