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May 19, 2020; 94 (20) Null Hypothesis

Seasonal influenza vaccine and Guillain-Barré syndrome

A self-controlled case series study

View ORCID ProfileClémence Grave, View ORCID ProfilePauline Boucheron, View ORCID ProfileJérémie Rudant, View ORCID ProfileYann Mikaeloff, View ORCID ProfilePascale Tubert-Bitter, View ORCID ProfileSylvie Escolano, View ORCID ProfileMounia N. Hocine, Joël Coste, View ORCID ProfileAlain Weill
First published February 25, 2020, DOI: https://doi.org/10.1212/WNL.0000000000009180
Clémence Grave
From the Department of Studies in Public Health (C.G., P.B., J.R., J.C., A.W.), French National Health Insurance, Paris; Assistance Publique-Hôpitaux de Paris (Y.M.), Unité de Rééducation Neurologique Infantile, Hôpital Bicêtre; CESP, Faculté de Médecine-Université Paris-Sud (Y.M.), Faculté de Médecine–UVSQ, INSERM, Université Paris-Saclay, Villejuif; Biostatistics and Pharmacoepidemiology (P.T.-B., S.E.), Inserm U1181 (B2PHI), UVSQ, University Paris Saclay, Institut Pasteur; and Laboratoire Modélisation (M.N.H.), Epidémiologie et Surveillance des Risques Sanitaires, Conservatoire National des Arts et Métiers, Paris, France.
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Pauline Boucheron
From the Department of Studies in Public Health (C.G., P.B., J.R., J.C., A.W.), French National Health Insurance, Paris; Assistance Publique-Hôpitaux de Paris (Y.M.), Unité de Rééducation Neurologique Infantile, Hôpital Bicêtre; CESP, Faculté de Médecine-Université Paris-Sud (Y.M.), Faculté de Médecine–UVSQ, INSERM, Université Paris-Saclay, Villejuif; Biostatistics and Pharmacoepidemiology (P.T.-B., S.E.), Inserm U1181 (B2PHI), UVSQ, University Paris Saclay, Institut Pasteur; and Laboratoire Modélisation (M.N.H.), Epidémiologie et Surveillance des Risques Sanitaires, Conservatoire National des Arts et Métiers, Paris, France.
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Jérémie Rudant
From the Department of Studies in Public Health (C.G., P.B., J.R., J.C., A.W.), French National Health Insurance, Paris; Assistance Publique-Hôpitaux de Paris (Y.M.), Unité de Rééducation Neurologique Infantile, Hôpital Bicêtre; CESP, Faculté de Médecine-Université Paris-Sud (Y.M.), Faculté de Médecine–UVSQ, INSERM, Université Paris-Saclay, Villejuif; Biostatistics and Pharmacoepidemiology (P.T.-B., S.E.), Inserm U1181 (B2PHI), UVSQ, University Paris Saclay, Institut Pasteur; and Laboratoire Modélisation (M.N.H.), Epidémiologie et Surveillance des Risques Sanitaires, Conservatoire National des Arts et Métiers, Paris, France.
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Yann Mikaeloff
From the Department of Studies in Public Health (C.G., P.B., J.R., J.C., A.W.), French National Health Insurance, Paris; Assistance Publique-Hôpitaux de Paris (Y.M.), Unité de Rééducation Neurologique Infantile, Hôpital Bicêtre; CESP, Faculté de Médecine-Université Paris-Sud (Y.M.), Faculté de Médecine–UVSQ, INSERM, Université Paris-Saclay, Villejuif; Biostatistics and Pharmacoepidemiology (P.T.-B., S.E.), Inserm U1181 (B2PHI), UVSQ, University Paris Saclay, Institut Pasteur; and Laboratoire Modélisation (M.N.H.), Epidémiologie et Surveillance des Risques Sanitaires, Conservatoire National des Arts et Métiers, Paris, France.
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Pascale Tubert-Bitter
From the Department of Studies in Public Health (C.G., P.B., J.R., J.C., A.W.), French National Health Insurance, Paris; Assistance Publique-Hôpitaux de Paris (Y.M.), Unité de Rééducation Neurologique Infantile, Hôpital Bicêtre; CESP, Faculté de Médecine-Université Paris-Sud (Y.M.), Faculté de Médecine–UVSQ, INSERM, Université Paris-Saclay, Villejuif; Biostatistics and Pharmacoepidemiology (P.T.-B., S.E.), Inserm U1181 (B2PHI), UVSQ, University Paris Saclay, Institut Pasteur; and Laboratoire Modélisation (M.N.H.), Epidémiologie et Surveillance des Risques Sanitaires, Conservatoire National des Arts et Métiers, Paris, France.
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Sylvie Escolano
From the Department of Studies in Public Health (C.G., P.B., J.R., J.C., A.W.), French National Health Insurance, Paris; Assistance Publique-Hôpitaux de Paris (Y.M.), Unité de Rééducation Neurologique Infantile, Hôpital Bicêtre; CESP, Faculté de Médecine-Université Paris-Sud (Y.M.), Faculté de Médecine–UVSQ, INSERM, Université Paris-Saclay, Villejuif; Biostatistics and Pharmacoepidemiology (P.T.-B., S.E.), Inserm U1181 (B2PHI), UVSQ, University Paris Saclay, Institut Pasteur; and Laboratoire Modélisation (M.N.H.), Epidémiologie et Surveillance des Risques Sanitaires, Conservatoire National des Arts et Métiers, Paris, France.
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Mounia N. Hocine
From the Department of Studies in Public Health (C.G., P.B., J.R., J.C., A.W.), French National Health Insurance, Paris; Assistance Publique-Hôpitaux de Paris (Y.M.), Unité de Rééducation Neurologique Infantile, Hôpital Bicêtre; CESP, Faculté de Médecine-Université Paris-Sud (Y.M.), Faculté de Médecine–UVSQ, INSERM, Université Paris-Saclay, Villejuif; Biostatistics and Pharmacoepidemiology (P.T.-B., S.E.), Inserm U1181 (B2PHI), UVSQ, University Paris Saclay, Institut Pasteur; and Laboratoire Modélisation (M.N.H.), Epidémiologie et Surveillance des Risques Sanitaires, Conservatoire National des Arts et Métiers, Paris, France.
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Joël Coste
From the Department of Studies in Public Health (C.G., P.B., J.R., J.C., A.W.), French National Health Insurance, Paris; Assistance Publique-Hôpitaux de Paris (Y.M.), Unité de Rééducation Neurologique Infantile, Hôpital Bicêtre; CESP, Faculté de Médecine-Université Paris-Sud (Y.M.), Faculté de Médecine–UVSQ, INSERM, Université Paris-Saclay, Villejuif; Biostatistics and Pharmacoepidemiology (P.T.-B., S.E.), Inserm U1181 (B2PHI), UVSQ, University Paris Saclay, Institut Pasteur; and Laboratoire Modélisation (M.N.H.), Epidémiologie et Surveillance des Risques Sanitaires, Conservatoire National des Arts et Métiers, Paris, France.
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Alain Weill
From the Department of Studies in Public Health (C.G., P.B., J.R., J.C., A.W.), French National Health Insurance, Paris; Assistance Publique-Hôpitaux de Paris (Y.M.), Unité de Rééducation Neurologique Infantile, Hôpital Bicêtre; CESP, Faculté de Médecine-Université Paris-Sud (Y.M.), Faculté de Médecine–UVSQ, INSERM, Université Paris-Saclay, Villejuif; Biostatistics and Pharmacoepidemiology (P.T.-B., S.E.), Inserm U1181 (B2PHI), UVSQ, University Paris Saclay, Institut Pasteur; and Laboratoire Modélisation (M.N.H.), Epidémiologie et Surveillance des Risques Sanitaires, Conservatoire National des Arts et Métiers, Paris, France.
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Citation
Seasonal influenza vaccine and Guillain-Barré syndrome
A self-controlled case series study
Clémence Grave, Pauline Boucheron, Jérémie Rudant, Yann Mikaeloff, Pascale Tubert-Bitter, Sylvie Escolano, Mounia N. Hocine, Joël Coste, Alain Weill
Neurology May 2020, 94 (20) e2168-e2179; DOI: 10.1212/WNL.0000000000009180

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    Figure 1 Definition of the different observation periods of the study
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    Figure 2 Flow chart of the study

    GBS = Guillain-Barré syndrome.

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    Figure 3 Incidence rate ratio (IRR) of Guillain-Barré syndrome (GBS) after influenza vaccination in various patient subgroups, according to the self-controlled case series method

    IC = confidence interval.

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    Figure 4 Incidence rate ratio (IRR) of Guillain-Barré syndrome after influenza vaccine, sensitivity analyses

    IC = confidence interval.

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