- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01777074
Acceptability of Hepatitis B Vaccination in General Practitioners and Paediatricians (PRALINE)
31 janvier 2013 mis à jour par: GlaxoSmithKline
Measurement of the Changes in Acceptability of Hepatitis B Immunization Among General Practitioners and Open-care Paediatricians
The present study is conducted in order to assess the acceptability of Hepatitis B vaccination in French general practitioners and peadiatricians before and after reimbursement of the paediatric vaccine InfanrixHexa.
Two data measurement time points are planned, first before reimbursement and after reimbursement.
Aperçu de l'étude
Description détaillée
The aim of the study is to assess the acceptability of Hepatitis B immunization among general practitioners and open-care paediatricians.
This is a national, repeated transversal epidemiological study with two data measurement time-points over a period of two years (T1 in 2009, T2 in 2011, two different samples of physicians) in order to assess immunization practices before introduction of the reimbursement of InfanrixHexa®, during the transition period and then during the period following reimbursement of the vaccine.
At each collection time-point, two patient age groups will be investigated: 12-15 months and 24-27 months, thus providing measurements before/after reimbursement.
Type d'étude
Observationnel
Inscription (Réel)
474
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Agde cedex, France, 34303
- GSK Investigational Site
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Agen, France, 47000
- GSK Investigational Site
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Agen cedex, France, 47002
- GSK Investigational Site
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Aire sur la lys, France, 62120
- GSK Investigational Site
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Aizenay, France, 85190
- GSK Investigational Site
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Albi, France, 81000
- GSK Investigational Site
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Ales, France, 30100
- GSK Investigational Site
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Alleins, France, 13980
- GSK Investigational Site
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Amiens, France, 80080
- GSK Investigational Site
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Ancenis, France, 44150
- GSK Investigational Site
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Andresy, France, 78570
- GSK Investigational Site
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Angers, France, 49000
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Anglet, France, 64600
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Annecy, France, 74000
- GSK Investigational Site
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Annecy le vieux, France, 74940
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Antony, France, 92160
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Argenteuil, France, 95100
- GSK Investigational Site
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Arles, France, 13200
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Arnas, France, 69400
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Arsac, France, 33460
- GSK Investigational Site
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Asnieres sur seine, France, 92600
- GSK Investigational Site
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Aubagne, France, 13400
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Aubergenville, France, 78410
- GSK Investigational Site
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Aubervilliers, France, 93300
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Aucamville, France, 31140
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Auchy les mines, France, 62138
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Auriol, France, 13390
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Avignon, France, 84000
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Bagneux, France, 92220
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Bagnols sur ceze, France, 30200
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Bar le duc, France, 55000
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Barr, France, 67140
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Beaulieu les loches, France, 37600
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Beaumont, France, 63110
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Beaupreau, France, 49600
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Beausoleil, France, 06240
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Beauvais, France, 60000
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Belfort, France, 90000
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Bellegarde, France, 30127
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Berre l etang, France, 13130
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Besancon, France, 25000
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Bethune, France, 62400
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Betton, France, 35830
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Beziers, France, 34500
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Biarritz, France, 64200
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Bievres, France, 91570
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Biganos, France, 33380
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Biscarrosse, France, 40600
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Bischheim, France, 67800
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Bois guillaume cedex, France, 76235
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Bollene, France, 84500
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Boos, France, 76520
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Bordeaux, France, 33200
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Bordeaux, France, 33300
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Bosmie l aiguille, France, 87110
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Boulogne billancourt, France, 92100
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Bourg en bresse, France, 01000
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Bousse, France, 57310
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Brest, France, 29200
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Bron, France, 69677
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Bron, France, 69500
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Bruges cedex, France, 33520
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Buchy, France, 76750
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Caen, France, 14000
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Cambrai, France, 59400
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Camphin en carembault, France, 59133
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Cannes, France, 06400
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Carresse Cassaber, France, 64270
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Caveirac, France, 30820
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Cergy, France, 95000
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Cergy st christophe, France, 95800
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Cestas, France, 33610
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Chalamont, France, 01320
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Challans, France, 85300
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Chalon sur saone, France, 71100
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Chambly, France, 60230
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Champigny sur marne, France, 94500
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Chanteloup les vignes, France, 78570
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Chantilly, France, 60500
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Chartres, France, 28000
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Chassieu, France, 69680
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Chateauneuf les martigues, France, 13220
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Chatenois les forges, France, 90700
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Chatou, France, 78400
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Cherbourg - octeville, France, 50130
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Clamart, France, 92140
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Clapiers, France, 34830
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Clermont Ferrand, France, 63000
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Clermont ferrand, France, 63100
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Clichy, France, 92110
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Colmar, France, 68000
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Colomars, France, 06670
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Colombelles, France, 14460
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Combs la ville, France, 77380
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Compiegne, France, 60200
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Conde sur noireau, France, 14110
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Corbeil essonnes, France, 91100
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Courpiere, France, 63120
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Creutzwald, France, 57150
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Crolles, France, 38920
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Cugnaux, France, 31270
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Cusset, France, 03300
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Darnetal, France, 76160
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Deluz, France, 25960
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Dessenheim, France, 68600
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Digne les bains, France, 04000
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Divonne les bains, France, 01220
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Domene, France, 38420
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Domont, France, 95330
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Draguignan, France, 83300
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Einvaux, France, 54360
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Epinal cedex 9, France, 88051
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Equeurdreville hainneville, France, 50120
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Esquerdes, France, 62380
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Essey les Nancy, France, 54270
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Estrees st denis, France, 60190
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Evreux, France, 13500
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Evry, France, 91000
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Fecamp, France, 76400
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Fenioux, France, 79160
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Feurs, France, 42110
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Figeac, France, 46100
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Fontaine, France, 38600
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Fontaine les dijon, France, 21121
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Fontains, France, 77370
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Fontenay sous bois, France, 94120
- GSK Investigational Site
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Forges les eaux, France, 76440
- GSK Investigational Site
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Fouesnant, France, 29170
- GSK Investigational Site
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Foussais payre, France, 85240
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Francheville, France, 69340
- GSK Investigational Site
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Fumel, France, 47500
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Gamarde les bains, France, 40380
- GSK Investigational Site
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Gemozac, France, 17260
- GSK Investigational Site
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Gondecourt, France, 59147
- GSK Investigational Site
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Gonneville la mallet, France, 76280
- GSK Investigational Site
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Gouvieux, France, 60270
- GSK Investigational Site
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Gouy sous bellonne, France, 62112
- GSK Investigational Site
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Gouzeaucourt, France, 59231
- GSK Investigational Site
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Grenoble, France, 38000
- GSK Investigational Site
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Greoux les bains, France, 04800
- GSK Investigational Site
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Grigny, France, 91350
- GSK Investigational Site
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Guenange, France, 57310
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Haguenau, France, 67500
- GSK Investigational Site
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Hatten, France, 67690
- GSK Investigational Site
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Hesdin, France, 62140
- GSK Investigational Site
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Hoenheim, France, 67800
- GSK Investigational Site
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Houilles, France, 78800
- GSK Investigational Site
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Houplin ancoisne, France, 59263
- GSK Investigational Site
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Hyeres, France, 83400
- GSK Investigational Site
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Illkirch graffenstaden, France, 67400
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Istres, France, 13800
- GSK Investigational Site
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Jarny, France, 54800
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Joue les tours, France, 37300
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L aigle, France, 61300
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L huisserie, France, 53970
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La chapelle sur erdre, France, 44240
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La couronne, France, 16400
- GSK Investigational Site
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La creche, France, 79260
- GSK Investigational Site
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La garenne colombes, France, 92250
- GSK Investigational Site
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La madeleine, France, 59110
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La meziere, France, 35520
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La motte servolex, France, 73290
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La source orleans, France, 45100
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La talaudiere, France, 42350
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La voulte sur rhone, France, 07800
- GSK Investigational Site
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Lamarche sur saone, France, 21760
- GSK Investigational Site
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Lambersart, France, 59130
- GSK Investigational Site
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Landivisiau, France, 29400
- GSK Investigational Site
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Lanester, France, 56600
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Langon, France, 33210
- GSK Investigational Site
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Laval, France, 53000
- GSK Investigational Site
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Le Bouscat, France, 33110
- GSK Investigational Site
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Le barp, France, 33114
- GSK Investigational Site
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Le cannet, France, 06110
- GSK Investigational Site
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Le chesnay, France, 78150
- GSK Investigational Site
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Le creusot, France, 71200
- GSK Investigational Site
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Le havre, France, 76600
- GSK Investigational Site
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Le kremlin bicetre, France, 94270
- GSK Investigational Site
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Le lavandou, France, 83980
- GSK Investigational Site
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Le palais sur vienne, France, 87410
- GSK Investigational Site
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Le passage d' agen, France, 47520
- GSK Investigational Site
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Le rheu, France, 35650
- GSK Investigational Site
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Les Sables D'olonne, France
- GSK Investigational Site
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Les sables d olonne, France, 85100
- GSK Investigational Site
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Les ulis, France, 91940
- GSK Investigational Site
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Lesquin, France, 59810
- GSK Investigational Site
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Lille Cedex, France, 59020
- GSK Investigational Site
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Limas, France, 69400
- GSK Investigational Site
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Limoges, France, 87000
- GSK Investigational Site
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Lingolsheim, France, 67380
- GSK Investigational Site
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Lisieux, France, 14100
- GSK Investigational Site
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Lognes, France, 77185
- GSK Investigational Site
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Lomme, France, 59160
- GSK Investigational Site
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Loos en gohelle, France, 62750
- GSK Investigational Site
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Lorient, France, 56100
- GSK Investigational Site
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Luzinay, France, 38200
- GSK Investigational Site
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Lyon, France, 69008
- GSK Investigational Site
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Lyon, France, 69003
- GSK Investigational Site
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Lyon, France, 69007
- GSK Investigational Site
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Lyon, France, 69001
- GSK Investigational Site
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Malakoff, France, 92240
- GSK Investigational Site
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Mantes la ville, France, 78711
- GSK Investigational Site
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Marchenoir, France, 41370
- GSK Investigational Site
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Marcq en baroeul, France, 59700
- GSK Investigational Site
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Marguerittes, France, 30320
- GSK Investigational Site
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Marmande, France, 47200
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Marnay, France, 70150
- GSK Investigational Site
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Marseille, France, 13008
- GSK Investigational Site
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Marseille, France, 13009
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Marseille, France, 13005
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Marseille, France, 13007
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Marseille, France, 13012
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Marseille, France, 13015
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Martigues, France, 13500
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Martin eglise, France, 76370
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Martinsart, France, 59113
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Mauze sur mignon, France, 79210
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Meaux, France, 77100
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Merignac, France, 33700
- GSK Investigational Site
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Merkwiller pechelbronn, France, 67250
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Mery sur oise, France, 95540
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Metz, France, 57070
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Meudon, France, 92360
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Meylan, France, 38240
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Meyssac, France, 19500
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Mirecourt, France, 88500
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Moivrons, France, 54760
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Molsheim, France, 67120
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Mondeville, France, 14120
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Mons en baroeul, France, 59370
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Montauban, France, 82000
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Montelimar, France, 26200
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Monteux, France, 84170
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Montfermeil, France, 93370
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Montgeron, France, 91230
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Montigny le bretonneux, France, 78180
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Montigny les metz, France, 57950
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Montoire sur le loir, France, 41800
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Montpellier, France, 34080
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Montpellier, France, 34000
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Montreuil, France, 93100
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Morlaas, France, 64160
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Morlaix, France, 29600
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Mornas, France, 84550
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Mouans sartoux, France, 06370
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Moutiers tarentaise, France, 73600
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Moyeuvre grande, France, 57250
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Mur de sologne, France, 41230
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Nanterre, France, 92000
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Nantes, France, 44300
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Nemours, France, 77140
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Neuville sur saone, France, 69250
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Niort, France, 79000
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Nogent sur marne, France, 94130
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Noisy le roi, France, 78590
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Noyon, France, 60400
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Obernai, France, 67210
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Oloron ste marie, France, 64400
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Orleans, France, 45100
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Orleans, France, 45000
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Orthez, France, 64300
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Oucques, France, 41290
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Ouistreham, France, 14150
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Oust, France, 09140
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Ozoir la ferriere, France, 77330
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Palaiseau, France, 91120
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Pamiers, France, 09100
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Paris, France, 75018
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Paris, France, 75013
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Paris, France, 75012
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Paris, France, 75015
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Paris, France, 75006
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Paris, France, 75005
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Paris, France, 75014
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Paris, France, 75020
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Paris, France, 75011
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Paris, France, 75008
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Paris, France, 75009
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Paris, France, 75016
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Paris, France, France
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Pau, France, 64000
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Pau cedex, France, 64075
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Pertuis, France, 84120
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Pierrefitte sur sauldre, France, 41300
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Plouguernevel, France, 22110
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Pont a mousson, France, 54700
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Pont l abbe d arnoult, France, 17250
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Pont ste maxence, France, 60700
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Pontarlier, France, 25300
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Pornic, France, 44210
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Port sur saone, France, 70170
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Provins, France, 77160
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Publier, France, 74500
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Puteaux, France, 92800
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Quevreville la poterie, France, 76520
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Raches, France, 59194
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Rennes, France, 35000
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Rennes, France, 35200
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Rennes, France, 35700
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Reze, France, 44400
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Rillieux la pape, France, 69140
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Riom, France, 63200
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Rivery, France, 80136
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Roanne, France, 42300
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Roche la moliere, France, 42230
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Rodez, France, 12000
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Romainville, France, 93230
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Romans sur isere, France, 26100
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Romille, France, 35850
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Ronchin, France, 59790
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Rosieres en santerre, France, 80170
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Rouen, France, 76000
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Royan, France, 17200
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Ruy, France, 38300
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Sahurs, France, 76113
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Saint-Aubin, France, 39410
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Saintes, France, 17100
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Sanary sur mer, France, 83110
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Segonzac, France, 16130
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Segré, France, 49500
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Selestat, France, 67600
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Sens, France, 89100
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Septemes les vallons, France, 13240
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Serres, France, 05700
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Sillery, France, 51500
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Soissons, France, 02200
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Sorgues, France, 84700
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St astier, France, 24110
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St aubin sur scie, France, 76550
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St brevin les pins, France, 44250
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St brieuc, France, 22000
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St chamond, France, 42400
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St cheron, France, 91530
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St cloud, France, 92210
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St cyr au mont d'or, France, 69450
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St denis, France, 93200
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St etienne, France, 42100
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St etienne de montluc, France, 44360
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St flour, France, 15100
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St genis laval, France, 69230
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St germain les arpajon, France, 91180
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St herblain, France, 44800
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St ismier, France, 38330
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St jean, France, 31240
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St jean de la ruelle, France, 45140
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St leu la foret, France, 95320
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St louis, France, 68300
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St loup sur semouse, France, 70800
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St malo, France, 35400
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St nazaire, France, 44600
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St pierre d irube, France, 64990
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St pol sur mer, France, 59430
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St priest, France, 69800
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St remy de provence, France, 13210
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St tropez, France, 83990
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Ste foy la grande, France, 33220
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Ste maxime, France, 83120
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Strasbourg, France, 67000
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Strasbourg, France, 67100
- GSK Investigational Site
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Strasbourg cedex, France, 67082
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Sucy en brie, France, 94370
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Suresnes, France, 92150
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Talence, France, 33400
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Tarascon, France, 13150
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Thiais, France, 94320
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Thonon les bains, France, 74200
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Thun st amand, France, 59158
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Toul, France, 54200
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Toulon, France, 83000
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Toulon, France, 83200
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Toulouse, France, 31500
- GSK Investigational Site
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Tours, France, 37100
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Trie chateau, France, 60590
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Troyes, France, 10000
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Vabres l abbaye, France, 12400
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Val de vesle, France, 51360
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Valence, France, 26000
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Vallauris, France, 06220
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Vandoeuvre les nancy, France, 54500
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Vannes, France, 56000
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Vannes cedex, France, 56034
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Vaugneray, France, 69670
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Vaulx en velin, France, 69120
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Vaureal, France, 95490
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Vaux le penil, France, 77000
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Vendargues, France, 34740
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Vernouillet, France, 78540
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Versailles, France, 78000
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Vertou, France, 44120
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Villars les Dombes, France, 01330
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Villeblevin, France, 89340
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Villeneuve d ascq cedex, France, 59658
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Villeurbanne cedex, France, 69626
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Villiers sur marne, France, 94350
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Vincennes, France, 94300
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Viry chatillon, France, 91170
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Vitrolles, France, 13127
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Vitry sur Seine, France, 94400
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Voreppe, France, 38340
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Wattignies, France, 59139
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Yerres, France, 91330
- GSK Investigational Site
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Zillisheim, France, 68720
- GSK Investigational Site
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
An eligibility register will be kept throughout the inclusion period by the investigators.
All children aged 12 to 15 months and 24 to 27 months, seen by the physician during this period, will be entered on this register General practitioners and open-care paediatricians drawn at random and agreeing to participate in the study.
La description
Inclusion Criteria:
• Children on the eligibility register complying with the investigator's immunization policy (children followed by the investigator since their birth, whose immunization regimen has been managed by the investigator).
Exclusion Criteria:
- Children on the eligibility register not complying with the investigator's immunization policy.
- Refusal of the patient.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Generalist physicians Cohort
|
Questionnaire, Vaccination book
|
|
Paediatricians Cohort
|
Questionnaire, Vaccination book
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Change in the proportion of physicians with at least 50% of infants immunized against Hepatitis B.
Délai: 4 years
|
4 years
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Type of physicians, based on the questionnaire regarding immunization practices and established at each measurement time point.
Délai: 4 years
|
4 years
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 novembre 2009
Achèvement primaire (Réel)
1 avril 2012
Achèvement de l'étude (Réel)
1 avril 2012
Dates d'inscription aux études
Première soumission
24 janvier 2013
Première soumission répondant aux critères de contrôle qualité
24 janvier 2013
Première publication (Estimation)
28 janvier 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
4 février 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
31 janvier 2013
Dernière vérification
1 janvier 2013
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections transmissibles par le sang
- Maladies transmissibles
- Maladies du foie
- Hépatite, virale, humaine
- Infections à Hépadnaviridae
- Infections par le virus de l'ADN
- Infections à entérovirus
- Infections à Picornaviridae
- Hépatite B
- Hépatite
- Hépatite A
Autres numéros d'identification d'étude
- 113385
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .