Abstract
| Original language | English |
|---|---|
| Pages (from-to) | 4448-4458 |
| Number of pages | 11 |
| Journal | Vaccine |
| Volume | 31 |
| Issue number | 40 |
| DOIs | |
| Publication status | Published - Sept 2013 |
Keywords
- Adjuvant
- Adverse events following immunization (AEFI)
- Guillain Barré Syndrome (GBS)
- International
- Monovalent H1N1 Vaccine (H1N1)
- Self-controlled case-series method (SCCS)
- influenza vaccine
- article
- data base
- drug safety
- follow up
- Guillain Barre syndrome
- human
- immune response
- immunization
- incidence
- influenza A (H1N1)
- influenza vaccination
- pandemic
- priority journal
- risk assessment
- risk factor
- seasonal variation
- cerebrospinal fluid
- Clinical Practice Research Datalink
- CPRD
- CSF
- Department of Defense
- Department of Veterans Affairs
- DoD
- general practitioner
- GP
- ICPI
- Integrated Primary Care Information Database
- Maccabi
- Maccabi Health Maintenance Organization
- MCRI
- Murdoch Children's Research Institute
- National Neuroscience Institute Singapore General Hospital
- National Neuroscience Institute Tan Tock Seng Hospital
- NNI/CGH
- NNI/TTSH
- Post-Licensure Rapid Immunization Safety Monitoring
- PRISM
- VA
- Vaccine Adverse Event Surveillance and Communication Consortium
- Vaccine Safety Datalink
- VAESCO
- VSD
- Databases, Factual
- Guillain-Barre Syndrome
- Humans
- Influenza A Virus, H1N1 Subtype
- Influenza Vaccines
- Influenza, Human
- International Cooperation
- Risk
- Vaccination
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In: Vaccine, Vol. 31, No. 40, 09.2013, p. 4448-4458.
Research output: Contribution to journal › Article › Research › peer-review
TY - JOUR
T1 - International collaboration to assess the risk of Guillain Barré Syndrome following Influenza A (H1N1) 2009 monovalent vaccines.
AU - Dodd, C.N.
AU - Romio, S.A.
AU - Black, S.
AU - Vellozzi, C.
AU - Andrews, N.
AU - Sturkenboom, M.
AU - Zuber, P.
AU - Hua, W.
AU - Bonhoeffer, J.
AU - Buttery, J.
AU - Crawford, N.
AU - Deceuninck, G.
AU - de Vries, C.
AU - De Wals, P.
AU - Gimeno, M.V.G.
AU - Heijbel, H.
AU - Hughes, H.
AU - Hur, K.
AU - Hviid, A.
AU - Kelman, J.
AU - Kilpi, T.
AU - Chuang, S.K.
AU - Macartney, K.
AU - Rett, M.
AU - Lopez-Callada, V.R.
AU - Salmon, D.
AU - Sanchez, F.G.
AU - Sanz, N.
AU - Silverman, B.
AU - Storsaeter, J.
AU - Thirugnanam, U.
AU - van der Maas, N.
AU - Yih, K.
AU - Zhang, T.
AU - Izurieta, H.
AU - Addis, A.
AU - Akhtar, A.
AU - Cope, J.
AU - Davis, R.
AU - Gargiullo, P.
AU - Kurz, X.
AU - Law, B.
AU - Sahinovic, I.
AU - Tokars, J.
AU - Serrano, P.
AU - Cheng, A.
AU - Charles, P.
AU - Clothier, H.
AU - Day, B.
AU - Day, T.
AU - Gates, P.
AU - MacDonnell, R.
AU - Roberts, L.
AU - Rodriguez-Casero, V.
AU - Wijeratne, T.
AU - Kiers, L.
AU - Blyth, C.
AU - Booy, R.
AU - Elliott, E.
AU - Gold, M.
AU - Marshall, H.
AU - McIntyre, P.
AU - Richmond, P.
AU - Royle, J.
AU - Wood, N.
AU - Zurynski, Y.
AU - Calvo, G.
AU - Campins, M.
AU - Corominas, N.
AU - Torres, F.
AU - Valls, J.
AU - Vilella, A.
AU - Dutra, D.
AU - Eick-Cost, A.
AU - Jackson, H.M.
AU - Garman, P.
AU - Hu, Z.
AU - Rigo, M.
AU - Badoo, J.
AU - Cho, D
AU - Polakowski, L.L.
AU - Sandhu, S.K.
AU - Sun, G.
AU - Chan, H.-S.S.
AU - Chan, K.-Y.
AU - Cheung, R.
AU - Cheung, Y-F.
AU - Cherk, S.
AU - Chuang, S.K
AU - Fok, J.W.-M.
AU - Fung, B.-H.
AU - Ko, K.-F.
AU - Lau, K.W.
AU - Lau, K.-K.
AU - Li, P.
AU - Liu, H.-T.
AU - Liu, S.-H.
AU - Mok, T.
AU - So, J.
AU - Wong, W.
AU - Wu, S.-P.
AU - Avagyan, A.
AU - Ball, R.
AU - Burwen, D.
AU - Franks, R.L.
AU - Gibbs, J.M.
AU - Kliman, R.E.
AU - Kropp, G.F.
AU - MaCurdy, T.E.
AU - Sandhu, S.-D.K.
AU - Worrall, C.M.
AU - Fuentes, D.E.F.
AU - González, P.C.O.
AU - Reyna, J.
AU - Vázquez, R.P.V.
AU - Kulldorff, M.
AU - Lee, G.
AU - Lieu, T.A.
AU - Platt, R.
AU - Serres, G.D.
AU - Jabin, K.
AU - Soh, B.L.S.
AU - Arnheim-Dahlstrom, L.
AU - Castot, A.
AU - de Melker, H.
AU - Dieleman, J.
AU - Hallgren, J.
AU - Jacobs, B.
AU - Johansen, K.
AU - Kramarz, P.
AU - Lapeyre, M.
AU - Leino, T.
AU - Molgaard-Nielsen, D.
AU - Mosseveld, M.
AU - Olberg, H.K.
AU - Sammon, C.-M.
AU - Saussier, C.
AU - Schuemie, M.
AU - Sommet, A.
AU - Sparen, P.
AU - Svanstrom, H.
AU - Vanrolleghem, A.
AU - Weibel, D.
AU - Domingo, J.D.
AU - Esparza, J.L.
AU - Lucas, R.M.O.
AU - Maseres, J.B.M.
AU - Sánchez, J.L.A.
AU - Sánchez, M.G.
AU - Viguer, V.Z.
AU - Cunningham, F.
AU - Thakkar, B.
AU - Zhang, R.
N1 - Cited By :78 Export Date: 17 February 2022 CODEN: VACCD Correspondence Address: Dodd, C.N.; Department of Biostatistics and Epidemiology, , Cincinnati, OH, United States; email: [email protected] Funding details: Pfizer Funding details: GlaxoSmithKline, GSK Funding text 1: Tao Zhang has received research grant support for other work from Pfizer. Funding text 2: Philippe De Wals has received research grant support for other work from GlaxoSmithKline. References: (2012) WHO/IVB, , World Health Organization, Global Vaccine Safety Blueprint; Mahoney, R.T., Maynard, J.E., The introduction of new vaccines into developing countries. 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PY - 2013/9
Y1 - 2013/9
N2 - Background: The global spread of the 2009 novel pandemic influenza A (H1N1) virus led to the accelerated production and distribution of monovalent 2009 Influenza A (H1N1) vaccines (pH1N1). This pandemic provided the opportunity to evaluate the risk of Guillain-Barré syndrome (GBS), which has been an influenza vaccine safety concern since the swine flu pandemic of 1976, using a common protocol among high and middle-income countries. The primary objective of this project was to demonstrate the feasibility and utility of global collaboration in the assessment of vaccine safety, including countries both with and without an established infrastructure for vaccine active safety surveillance. A second objective, included a priori, was to assess the risk of GBS following pH1N1 vaccination. Methods: The primary analysis used the self-controlled case series (SCCS) design to estimate the relative incidence (RI) of GBS in the 42 days following vaccination with pH1N1 vaccine in a pooled analysis across databases and in analysis using a meta-analytic approach. Results: We found a relative incidence of GBS of 2.42 (95% CI 1.58-3.72) in the 42 days following exposure to pH1N1 vaccine in analysis of pooled data and 2.09 (95% CI 1.28-3.42) using the meta-analytic approach. Conclusions: This study demonstrates that international collaboration to evaluate serious outcomes using a common protocol is feasible. The significance and consistency of our findings support a conclusion of an association between 2009 H1N1 vaccination and GBS. Given the rarity of the event the relative incidence found does not provide evidence in contradiction to international recommendations for the continued use of influenza vaccines. © 2013 Elsevier Ltd.
AB - Background: The global spread of the 2009 novel pandemic influenza A (H1N1) virus led to the accelerated production and distribution of monovalent 2009 Influenza A (H1N1) vaccines (pH1N1). This pandemic provided the opportunity to evaluate the risk of Guillain-Barré syndrome (GBS), which has been an influenza vaccine safety concern since the swine flu pandemic of 1976, using a common protocol among high and middle-income countries. The primary objective of this project was to demonstrate the feasibility and utility of global collaboration in the assessment of vaccine safety, including countries both with and without an established infrastructure for vaccine active safety surveillance. A second objective, included a priori, was to assess the risk of GBS following pH1N1 vaccination. Methods: The primary analysis used the self-controlled case series (SCCS) design to estimate the relative incidence (RI) of GBS in the 42 days following vaccination with pH1N1 vaccine in a pooled analysis across databases and in analysis using a meta-analytic approach. Results: We found a relative incidence of GBS of 2.42 (95% CI 1.58-3.72) in the 42 days following exposure to pH1N1 vaccine in analysis of pooled data and 2.09 (95% CI 1.28-3.42) using the meta-analytic approach. Conclusions: This study demonstrates that international collaboration to evaluate serious outcomes using a common protocol is feasible. The significance and consistency of our findings support a conclusion of an association between 2009 H1N1 vaccination and GBS. Given the rarity of the event the relative incidence found does not provide evidence in contradiction to international recommendations for the continued use of influenza vaccines. © 2013 Elsevier Ltd.
KW - Adjuvant
KW - Adverse events following immunization (AEFI)
KW - Guillain Barré Syndrome (GBS)
KW - International
KW - Monovalent H1N1 Vaccine (H1N1)
KW - Self-controlled case-series method (SCCS)
KW - influenza vaccine
KW - article
KW - data base
KW - drug safety
KW - follow up
KW - Guillain Barre syndrome
KW - human
KW - immune response
KW - immunization
KW - incidence
KW - influenza A (H1N1)
KW - influenza vaccination
KW - pandemic
KW - priority journal
KW - risk assessment
KW - risk factor
KW - seasonal variation
KW - cerebrospinal fluid
KW - Clinical Practice Research Datalink
KW - CPRD
KW - CSF
KW - Department of Defense
KW - Department of Veterans Affairs
KW - DoD
KW - general practitioner
KW - GP
KW - ICPI
KW - Integrated Primary Care Information Database
KW - Maccabi
KW - Maccabi Health Maintenance Organization
KW - MCRI
KW - Murdoch Children's Research Institute
KW - National Neuroscience Institute Singapore General Hospital
KW - National Neuroscience Institute Tan Tock Seng Hospital
KW - NNI/CGH
KW - NNI/TTSH
KW - Post-Licensure Rapid Immunization Safety Monitoring
KW - PRISM
KW - VA
KW - Vaccine Adverse Event Surveillance and Communication Consortium
KW - Vaccine Safety Datalink
KW - VAESCO
KW - VSD
KW - Databases, Factual
KW - Guillain-Barre Syndrome
KW - Humans
KW - Influenza A Virus, H1N1 Subtype
KW - Influenza Vaccines
KW - Influenza, Human
KW - International Cooperation
KW - Risk
KW - Vaccination
UR - http://www.ncbi.nlm.nih.gov/pubmed/23770307
U2 - 10.1016/j.vaccine.2013.06.032
DO - 10.1016/j.vaccine.2013.06.032
M3 - Article
C2 - 23770307
SN - 0264-410X
VL - 31
SP - 4448
EP - 4458
JO - Vaccine
JF - Vaccine
IS - 40
ER -