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Advance system testing: Vaccine benefit studies using multi-country electronic health data - The example of pertussis vaccination.
Tin Tin Htar, Myint; de Ridder, Maria; Braeye, Toon; Correa, Ana; McGee, Chris; de Lusignan, Simon; Duarte-Salles, Talita; Huerta-Alvarez, Consuelo; Martín-Merino, Elisa; Tramontan, Lara; Danieli, Giorgia; Picelli, Gino; van der Maas, Nicoline; Berencsi, Klara; Arnheim-Dahlström, Lisen; Heininger, Ulrich; Emborg, Hanne-Dorthe; Weibel, Daniel; Bollaerts, Kaatje; Sturkenboom, Miriam.
Afiliación
  • Tin Tin Htar M; Clinical Epidemiology, Pfizer, 23-25 Avenue du Dr Lannelongue, 75014 Paris, France. Electronic address: myint.tintinhtar@pfizer.com.
  • de Ridder M; Erasmus University Medical Center, PO Box 2014, 3000 CA Rotterdam, the Netherlands. Electronic address: m.deridder@erasmusmc.nl.
  • Braeye T; Sciensano, Rue Juliette Wytsmanstraat 14, 1050 Brussels, Belgium. Electronic address: toon.braeye@sciensano.be.
  • Correa A; University of Surrey, Guildford, Surrey GU2 7XH, UK.
  • McGee C; University of Surrey, Guildford, Surrey GU2 7XH, UK; Royal College of General Practitioners Research and Surveillance Centre, 30 Euston Square, London NW1 2FB, UK. Electronic address: c.mcgee@surrey.ac.uk.
  • de Lusignan S; University of Surrey, Guildford, Surrey GU2 7XH, UK; Royal College of General Practitioners Research and Surveillance Centre, 30 Euston Square, London NW1 2FB, UK. Electronic address: s.lusignan@surrey.ac.uk.
  • Duarte-Salles T; Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain. Electronic address: tduarte@idiapjgol.org.
  • Huerta-Alvarez C; Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency of Medicines and Medical Devices (AEMPS), Madrid, Spain. Electronic address: chuerta@aemps.es.
  • Martín-Merino E; Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency of Medicines and Medical Devices (AEMPS), Madrid, Spain. Electronic address: emartinm@aemps.es.
  • Tramontan L; PEDIANET, Padova, Italy; Consorzio Arsenal.IT, Veneto Region, Italy. Electronic address: ltramontan@consorzioarsenal.it.
  • Danieli G; PEDIANET, Padova, Italy; Consorzio Arsenal.IT, Veneto Region, Italy. Electronic address: gdanieli@consorzioarsenal.it.
  • Picelli G; PEDIANET, Padova, Italy. Electronic address: g.picelli@virgilio.it.
  • van der Maas N; National Institute for Public Health and the Environment (RIVM), Bilthoven, Netherlands. Electronic address: nicoline.van.der.maas@rivm.nl.
  • Berencsi K; Aarhus University Hospital, Olof Palmes Alle 43-45, DK-8200 Aarhus, Denmark. Electronic address: klara.berencsi@ndorms.ox.ac.uk.
  • Arnheim-Dahlström L; Karolina Institutet, 171 77 Stockholm, Sweden. Electronic address: lisen.arnheim.dahlstrom@ki.se.
  • Heininger U; University of Basel Children's Hospital, PO Box, CH 4033 Basel, Switzerland; University of Basel, Basel, Switzerland. Electronic address: Ulrich.Heininger@ukbb.ch.
  • Emborg HD; Statens Serum Institut, Artillerivej 5, DK-2300 Copenhagen, Denmark. Electronic address: HDE@ssi.dk.
  • Weibel D; Erasmus University Medical Center, PO Box 2014, 3000 CA Rotterdam, the Netherlands; VACCINE.GRID, Spitalstrasse 33, Basel, Switzerland. Electronic address: d.weibel@erasmusmc.nl.
  • Bollaerts K; P95, Epidemiology and Pharmacovigilance, Leuven, Belgium. Electronic address: Kaatje.Bollaerts@p-95.com.
  • Sturkenboom M; VACCINE.GRID, Spitalstrasse 33, Basel, Switzerland; P95, Epidemiology and Pharmacovigilance, Leuven, Belgium; Julius Global Health, University Medical Center Utrecht, Heidelberglaan 100, the Netherlands. Electronic address: miriam.sturkenboom@p-95.com.
Vaccine ; 38 Suppl 2: B31-B37, 2020 12 22.
Article en En | MEDLINE | ID: mdl-31677949
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vacuna contra la Tos Ferina / Tos Ferina Tipo de estudio: Etiology_studies / Observational_studies / Risk_factors_studies Límite: Child / Humans / Infant País/Región como asunto: Europa Idioma: En Revista: Vaccine Año: 2020 Tipo del documento: Article Pais de publicación: Países Bajos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vacuna contra la Tos Ferina / Tos Ferina Tipo de estudio: Etiology_studies / Observational_studies / Risk_factors_studies Límite: Child / Humans / Infant País/Región como asunto: Europa Idioma: En Revista: Vaccine Año: 2020 Tipo del documento: Article Pais de publicación: Países Bajos