TY - JOUR
T1 - Advance system testing: feasibility of using a network of health data bases for vaccine safety studies
AU - Weibel, Daniel
AU - Dodd, Caitlin
AU - Mahaux, Olivia
AU - Haguinet, Francois
AU - De Smedt, Tom
AU - Duarte-Salles, Talita
AU - Picelli, Gino
AU - Tramontan, Lara
AU - Danieli, Giorgia
AU - Correa, Ana
AU - Martin, Elisa
AU - Huerta, Consuelo
AU - Berensci, Klara
AU - Becker, Benedikt
AU - Emborg, Hanne-Dorthe
AU - Htar, Myint Tin Tin
AU - Bollaerts, Kaatje
AU - Bauchau, Vincent
AU - Titievsky, Lina
AU - Sturkenboom, Miriam
PY - 2018/8
Y1 - 2018/8
N2 - Background: The Accelerated Development of Vaccine benefit‐risk
Collaboration in Europe (ADVANCE) public private collaboration, aims
to develop and test a system for rapid benefit‐risk monitoring of vaccines
using health care databases in Europe.
Objectives: To test the feasibility of the ADVANCE system to generate
incidence rates (IRs) of events of interest (EI) associated with whole cell‐
(wP) and acellular‐ (aP) pertussis vaccines, in children prior to their pre‐
school‐entry booster, using common protocol and analytics.
Methods: The study population were children aged 1 month to
<6 years, during 2001‐2016, in 5 primary care databases (ie, Italy
(Pedianet), Spain (SIDIAP & BIFAP) and UK (THIN & RCGP)) and two
Danish hospital databases (AUH & SSI). IR of injection site reactions
(ISR), fever, somnolence, persistent crying, febrile or afebrile seizure/
convulsion, hypotonic‐hyporesponsive episode (HHE) were estimated
both in outcome specific risk windows following wP and aP vaccines
exposure and in non‐risk (baseline) periods (presented below as overall
IRs). A self‐controlled case series design was used to estimate the
dose specific Incidence Rate Ratio (IRR) between aP vs non‐risk and wP vs non‐risk in each database, when wP data were available. Heterogeneity
of individual database estimates were inspected, and
results benchmarked where possible, random‐effects meta‐analyses
were conducted for pooling of the IRR.
Results: In a study population of 5.9 Million the database specific
overall (ie, risk and non‐risk periods) IR per 1000 PY varied between
0.5 and 3.1 for ISR, 8.5‐491.0 for fever, 0.01‐0.44 for somnolence,
2.4‐22.1 for persistent crying, 2.6‐14.2 for febrile convulsion, and
between 0.2 and 1.5 for HHE. IRs were similar within the primary care
databases, but hospital‐based databases could not estimate ISR, somnolence,
and persistent crying. The IRR showed higher risks for wP
compared with aP for febrile convulsions, fever, ISR, persistent crying,
and somnolence for 1st dose, except for somnolence 2nd dose and
febrile convulsions 3rd dose. The risk of HHE was higher following
wP compared with aP. IRR and IR were consistent with available literature
and expert feedback, except for IRR of HHE.
Conclusions: Within ADVANCE we demonstrated the feasibility of
generating vaccine safety data in a public private collaboration of a
distributed health care database network. This study was for system
testing and not to inform regulatory/clinical decisions on pertussis
vaccination
AB - Background: The Accelerated Development of Vaccine benefit‐risk
Collaboration in Europe (ADVANCE) public private collaboration, aims
to develop and test a system for rapid benefit‐risk monitoring of vaccines
using health care databases in Europe.
Objectives: To test the feasibility of the ADVANCE system to generate
incidence rates (IRs) of events of interest (EI) associated with whole cell‐
(wP) and acellular‐ (aP) pertussis vaccines, in children prior to their pre‐
school‐entry booster, using common protocol and analytics.
Methods: The study population were children aged 1 month to
<6 years, during 2001‐2016, in 5 primary care databases (ie, Italy
(Pedianet), Spain (SIDIAP & BIFAP) and UK (THIN & RCGP)) and two
Danish hospital databases (AUH & SSI). IR of injection site reactions
(ISR), fever, somnolence, persistent crying, febrile or afebrile seizure/
convulsion, hypotonic‐hyporesponsive episode (HHE) were estimated
both in outcome specific risk windows following wP and aP vaccines
exposure and in non‐risk (baseline) periods (presented below as overall
IRs). A self‐controlled case series design was used to estimate the
dose specific Incidence Rate Ratio (IRR) between aP vs non‐risk and wP vs non‐risk in each database, when wP data were available. Heterogeneity
of individual database estimates were inspected, and
results benchmarked where possible, random‐effects meta‐analyses
were conducted for pooling of the IRR.
Results: In a study population of 5.9 Million the database specific
overall (ie, risk and non‐risk periods) IR per 1000 PY varied between
0.5 and 3.1 for ISR, 8.5‐491.0 for fever, 0.01‐0.44 for somnolence,
2.4‐22.1 for persistent crying, 2.6‐14.2 for febrile convulsion, and
between 0.2 and 1.5 for HHE. IRs were similar within the primary care
databases, but hospital‐based databases could not estimate ISR, somnolence,
and persistent crying. The IRR showed higher risks for wP
compared with aP for febrile convulsions, fever, ISR, persistent crying,
and somnolence for 1st dose, except for somnolence 2nd dose and
febrile convulsions 3rd dose. The risk of HHE was higher following
wP compared with aP. IRR and IR were consistent with available literature
and expert feedback, except for IRR of HHE.
Conclusions: Within ADVANCE we demonstrated the feasibility of
generating vaccine safety data in a public private collaboration of a
distributed health care database network. This study was for system
testing and not to inform regulatory/clinical decisions on pertussis
vaccination
M3 - Meeting Abstract
SN - 1053-8569
VL - 27
SP - 170
JO - Pharmacoepidemiology and Drug Safety
JF - Pharmacoepidemiology and Drug Safety
IS - S2
ER -