TY - JOUR
T1 - Advance system testing
T2 - Vaccine benefit studies using multi-country electronic health data - The example of pertussis vaccination
AU - Tin Tin Htar, Myint
AU - de Ridder, Maria
AU - Braeye, Toon
AU - Correa, Ana
AU - McGee, Chris
AU - de Lusignan, Simon
AU - Duarte-Salles, Talita
AU - Huerta, Consuelo
AU - Martín-Merino, Elisa
AU - Tramontan, Lara
AU - Danieli, Giorgia
AU - Picelli, Gino
AU - van der Maas, Nicoline
AU - Berencsi, Klara
AU - Arnheim-Dahlström, Lisen
AU - Heininger, Ulrich
AU - Emborg, Hanne-Dorthe
AU - Weibel, Daniel
AU - Bollaerts, Kaatje
AU - Sturkenboom, Miriam
N1 - Funding Information:
The Innovative Medicines Initiative Joint Undertaking funded this project under ADVANCE grant agreement n° 115557, resources of which were composed of a financial contribution from the European Union's Seventh Framework Programme (FP7/2007–2013) and in kind contributions from EFPIA member companies.
Funding Information:
The authors would like to thank Tyra Grove (SSI), Vincent Bauchau (GSK), Lina Titievsky (Pfizer) and the ADVANCE Steering Committee Members for their useful input into this study and comments on the manuscript. They also would like to acknowledge medical writing and editorial assistance from Margaret Haugh, MediCom Consult, Villeurbanne, France.
Publisher Copyright:
© 2019 The Authors
PY - 2020/12/22
Y1 - 2020/12/22
N2 - The Accelerated Development of VAccine benefit-risk Collaboration in Europe (ADVANCE), a public-private consortium, implemented and tested a distributed network system for the generation of evidence on the benefits-risks of marketed vaccines in Europe. We tested the system by estimating the incidence rate (IR) of pertussis and pertussis-related complications in children vaccinated with acellular (aP) and whole-cell (wP) pertussis vaccine. Data from seven electronic databases from four countries (Denmark: AUH and SSI, Spain: SIDIAP and BIFAP, UK: THIN and RCGP RSC and Italy: Pedianet) were included in a retrospective cohort analysis. Exposure was defined as any pertussis vaccination (aP or wP). The follow-up time started 14 days after the first dose. Children who had received any pertussis vaccine from January 1990 to December 2015 were included (those who switched type, or had unknown type were excluded). The outcomes of interest were confirmed or suspected pertussis and pertussis-related pneumonia and generalised convulsions within one month of pertussis diagnosis and death within three months of pertussis diagnosis. The cohort comprised 2,886,367 children ≤5 years of age. Data on wP and aP vaccination were available in three and seven databases, respectively. The IRs (per 100,000 person-years) for pertussis varied largely and ranged between 0.15 (95% CI: 0.12; 0.19) and 1.15 (95% CI: 1.07; 1.23), and the trends over time was consistent with those observed from national surveillance databases for confirmed pertussis. The pertussis IRs decreased as the number of wP and aP vaccine doses increased. Pertussis-related complications were rare (89 pneumonia, 7 generalised convulsions and no deaths) and their relative risk (vs. non-pertussis) could not be reliably estimated. The study demonstrated the feasibility of the ADVANCE system to estimate the change in pertussis IRs following pertussis vaccination. Larger sample sizes would provide additional power to compare the risk for complications between children with and without pertussis. The feasibility of vaccine-type specific effectiveness studies may be considered in the future.
AB - The Accelerated Development of VAccine benefit-risk Collaboration in Europe (ADVANCE), a public-private consortium, implemented and tested a distributed network system for the generation of evidence on the benefits-risks of marketed vaccines in Europe. We tested the system by estimating the incidence rate (IR) of pertussis and pertussis-related complications in children vaccinated with acellular (aP) and whole-cell (wP) pertussis vaccine. Data from seven electronic databases from four countries (Denmark: AUH and SSI, Spain: SIDIAP and BIFAP, UK: THIN and RCGP RSC and Italy: Pedianet) were included in a retrospective cohort analysis. Exposure was defined as any pertussis vaccination (aP or wP). The follow-up time started 14 days after the first dose. Children who had received any pertussis vaccine from January 1990 to December 2015 were included (those who switched type, or had unknown type were excluded). The outcomes of interest were confirmed or suspected pertussis and pertussis-related pneumonia and generalised convulsions within one month of pertussis diagnosis and death within three months of pertussis diagnosis. The cohort comprised 2,886,367 children ≤5 years of age. Data on wP and aP vaccination were available in three and seven databases, respectively. The IRs (per 100,000 person-years) for pertussis varied largely and ranged between 0.15 (95% CI: 0.12; 0.19) and 1.15 (95% CI: 1.07; 1.23), and the trends over time was consistent with those observed from national surveillance databases for confirmed pertussis. The pertussis IRs decreased as the number of wP and aP vaccine doses increased. Pertussis-related complications were rare (89 pneumonia, 7 generalised convulsions and no deaths) and their relative risk (vs. non-pertussis) could not be reliably estimated. The study demonstrated the feasibility of the ADVANCE system to estimate the change in pertussis IRs following pertussis vaccination. Larger sample sizes would provide additional power to compare the risk for complications between children with and without pertussis. The feasibility of vaccine-type specific effectiveness studies may be considered in the future.
KW - Children
KW - Database study
KW - Feasibility study
KW - Pertussis incidence
KW - Pertussis vaccination
KW - Pertussis-related complications
UR - http://www.scopus.com/inward/record.url?scp=85097968565&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2019.08.078
DO - 10.1016/j.vaccine.2019.08.078
M3 - Article
C2 - 31677949
SN - 0264-410X
VL - 38
SP - B31-B37
JO - Vaccine
JF - Vaccine
IS - 2
ER -