NCT01777074

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
474

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2009

Typical duration for all trials

Geographic Reach
1 country

402 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
Last Updated

February 4, 2013

Status Verified

January 1, 2013

Enrollment Period

2.4 years

First QC Date

January 24, 2013

Last Update Submit

January 31, 2013

Conditions

Keywords

VaccinationAcceptabilityHepatitis B

Outcome Measures

Primary Outcomes (1)

  • Change in the proportion of physicians with at least 50% of infants immunized against Hepatitis B.

    4 years

Secondary Outcomes (1)

  • Type of physicians, based on the questionnaire regarding immunization practices and established at each measurement time point.

    4 years

Study Arms (2)

Generalist physicians Cohort

Other: Data collection

Paediatricians Cohort

Other: Data collection

Interventions

Questionnaire, Vaccination book

Generalist physicians CohortPaediatricians Cohort

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • 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).

You may not qualify if:

  • Children on the eligibility register not complying with the investigator's immunization policy.
  • Refusal of the patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (402)

GSK Investigational Site

Agde, 34303, France

Location

GSK Investigational Site

Agen, 47000, France

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GSK Investigational Site

Agen, 47002, France

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GSK Investigational Site

Aire-sur-la-Lys, 62120, France

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GSK Investigational Site

Aizenay, 85190, France

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GSK Investigational Site

Albi, 81000, France

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GSK Investigational Site

Alès, 30100, France

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GSK Investigational Site

Alleins, 13980, France

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GSK Investigational Site

Amiens, 80080, France

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GSK Investigational Site

Ancenis, 44150, France

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GSK Investigational Site

Andrésy, 78570, France

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GSK Investigational Site

Angers, 49000, France

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GSK Investigational Site

Anglet, 64600, France

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GSK Investigational Site

Annecy, 74000, France

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GSK Investigational Site

Annecy-le-Vieux, 74940, France

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GSK Investigational Site

Antony, 92160, France

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GSK Investigational Site

Argenteuil, 95100, France

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GSK Investigational Site

Arles, 13200, France

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GSK Investigational Site

Arnas, 69400, France

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GSK Investigational Site

Arsac, 33460, France

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GSK Investigational Site

Asnières-sur-Seine, 92600, France

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GSK Investigational Site

Aubagne, 13400, France

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GSK Investigational Site

Aubergenville, 78410, France

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Aubervilliers, 93300, France

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GSK Investigational Site

Aucamville, 31140, France

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GSK Investigational Site

Auchy-les-Mines, 62138, France

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GSK Investigational Site

Auriol, 13390, France

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GSK Investigational Site

Avignon, 84000, France

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GSK Investigational Site

Bagneux, 92220, France

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GSK Investigational Site

Bagnols-sur-Cèze, 30200, France

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GSK Investigational Site

Bar-le-Duc, 55000, France

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GSK Investigational Site

Barr, 67140, France

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GSK Investigational Site

Beaulieu-lès-Loches, 37600, France

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GSK Investigational Site

Beaumont, 63110, France

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Beaupréau, 49600, France

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Beausoleil, 06240, France

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Beauvais, 60000, France

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Belfort, 90000, France

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GSK Investigational Site

Bellegarde, 30127, France

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Berre-l'Étang, 13130, France

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Besançon, 25000, France

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Betton, 35830, France

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Béthune, 62400, France

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Béziers, 34500, France

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Biarritz, 64200, France

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Bièvres, 91570, France

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Biganos, 33380, France

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Biscarrosse, 40600, France

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Bischheim, 67800, France

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Bois-Guillaume, 76235, France

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Bollène, 84500, France

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Boos, 76520, France

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Bordeaux, 33200, France

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Bordeaux, 33300, France

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Bosmie-l'Aiguille, 87110, France

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Boulogne-Billancourt, 92100, France

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Bourg-en-Bresse, 01000, France

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Bousse, 57310, France

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Brest, 29200, France

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Bron, 69500, France

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Bron, 69677, France

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Bruges, 33520, France

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Buchy, 76750, France

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Caen, 14000, France

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Cambrai, 59400, France

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Camphin-en-Carembault, 59133, France

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Cannes, 06400, France

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Carresse-Cassaber, 64270, France

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Caveirac, 30820, France

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Cergy, 95000, France

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Cergy Saint Christophe, 95800, France

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Cestas, 33610, France

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Chalamont, 01320, France

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Challans, 85300, France

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Chalon-sur-Saône, 71100, France

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Chambly, 60230, France

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Champigny-sur-Marne, 94500, France

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Chanteloup-les-Vignes, 78570, France

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Chantilly, 60500, France

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Chartres, 28000, France

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Chassieu, 69680, France

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Chatou, 78400, France

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Châteauneuf-les-Martigues, 13220, France

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Châtenois-les-Forges, 90700, France

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Cherbourg - Octeville, 50130, France

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Clamart, 92140, France

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Clapiers, 34830, France

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Clermont-Ferrand, 63000, France

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Clermont-Ferrand, 63100, France

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Clichy, 92110, France

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Colmar, 68000, France

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Colomars, 06670, France

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Colombelles, 14460, France

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Combs-la-Ville, 77380, France

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Compiègne, 60200, France

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Condé-sur-Noireau, 14110, France

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Corbeil-Essonnes, 91100, France

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Courpière, 63120, France

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Creutzwald, 57150, France

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Crolles, 38920, France

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Cugnaux, 31270, France

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Cusset, 03300, France

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Darnétal, 76160, France

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Deluz, 25960, France

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Dessenheim, 68600, France

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Digne-les-Bains, 04000, France

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Divonne-les-Bains, 01220, France

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Domène, 38420, France

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Domont, 95330, France

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Draguignan, 83300, France

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Einvaux, 54360, France

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Esquerdes, 62380, France

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Essey-lès-Nancy, 54270, France

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Estrées-Saint-Denis, 60190, France

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Épinal, 88051, France

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Équeurdreville-Hainneville, 50120, France

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Évreux, 13500, France

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Évry, 91000, France

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Fenioux, 79160, France

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Feurs, 42110, France

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Fécamp, 76400, France

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Figeac, 46100, France

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Fontaine, 38600, France

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Fontaine-lès-Dijon, 21121, France

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Fontains, 77370, France

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Fontenay-sous-Bois, 94120, France

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Forges-les-Eaux, 76440, France

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Fouesnant, 29170, France

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Foussais-Payré, 85240, France

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Francheville, 69340, France

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Fumel, 47500, France

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Gamarde-les-Bains, 40380, France

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Gémozac, 17260, France

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Gondecourt, 59147, France

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Gonneville-la-Mallet, 76280, France

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Gouvieux, 60270, France

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Gouy-sous-Bellonne, 62112, France

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Gouzeaucourt, 59231, France

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Grenoble, 38000, France

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Gréoux-les-Bains, 04800, France

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Grigny, 91350, France

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Guénange, 57310, France

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Haguenau, 67500, France

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Hatten, 67690, France

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Hesdin, 62140, France

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Houilles, 78800, France

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Houplin-Ancoisne, 59263, France

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Hyères, 83400, France

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Hœnheim, 67800, France

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Illkirch-Graffenstaden, 67400, France

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Istres, 13800, France

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Jarny, 54800, France

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Joué-lès-Tours, 37300, France

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L'Aigle, 61300, France

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L'Huisserie, 53970, France

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GSK Investigational Site

La Chapelle-sur-Erdre, 44240, France

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La Couronne, 16400, France

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La Crèche, 79260, France

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GSK Investigational Site

La Garenne-Colombes, 92250, France

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La Madeleine, 59110, France

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La Mézière, 35520, France

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La Motte-Servolex, 73290, France

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La Source Orleans, 45100, France

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La Talaudière, 42350, France

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La Voulte-sur-Rhône, 07800, France

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Lamarche-sur-Saône, 21760, France

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Lambersart, 59130, France

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Landivisiau, 29400, France

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Lanester, 56600, France

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Langon, 33210, France

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Laval, 53000, France

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Le Barp, 33114, France

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Le Bouscat, 33110, France

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Le Cannet, 06110, France

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Le Chesnay, 78150, France

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Le Creusot, 71200, France

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Le Havre, 76600, France

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Le Kremlin-Bicêtre, 94270, France

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Le Lavandou, 83980, France

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Le Palais-sur-Vienne, 87410, France

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Le Passage D' Agen, 47520, France

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Le Rheu, 35650, France

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Les Sables-d'Olonne, 85100, France

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Les Sables-d'Olonne, France

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Les Ulis, 91940, France

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Lesquin, 59810, France

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Lille, 59020, France

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Limas, 69400, France

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Limoges, 87000, France

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Lingolsheim, 67380, France

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Lisieux, 14100, France

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GSK Investigational Site

Lognes, 77185, France

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Lomme, 59160, France

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GSK Investigational Site

Loos-en-Gohelle, 62750, France

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GSK Investigational Site

Lorient, 56100, France

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Luzinay, 38200, France

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GSK Investigational Site

Lyon, 69001, France

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GSK Investigational Site

Lyon, 69003, France

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GSK Investigational Site

Lyon, 69007, France

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GSK Investigational Site

Lyon, 69008, France

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Malakoff, 92240, France

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Mantes-la-Ville, 78711, France

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Marchenoir, 41370, France

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Marcq-en-Barœul, 59700, France

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Marguerittes, 30320, France

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Marmande, 47200, France

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Marnay, 70150, France

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Marseille, 13005, France

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GSK Investigational Site

Marseille, 13007, France

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GSK Investigational Site

Marseille, 13008, France

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GSK Investigational Site

Marseille, 13009, France

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GSK Investigational Site

Marseille, 13012, France

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GSK Investigational Site

Marseille, 13015, France

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Martigues, 13500, France

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Martin-Église, 76370, France

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Martinsart, 59113, France

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Mauze Sur Mignon, 79210, France

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Meaux, 77100, France

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Merkwiller-Pechelbronn, 67250, France

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Metz, 57070, France

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Meudon, 92360, France

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Meylan, 38240, France

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Meyssac, 19500, France

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Mérignac, 33700, France

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Méry-sur-Oise, 95540, France

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Mirecourt, 88500, France

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Moivrons, 54760, France

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Molsheim, 67120, France

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Mondeville, 14120, France

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Mons-en-Barœul, 59370, France

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Montauban, 82000, France

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Monteux, 84170, France

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Montélimar, 26200, France

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Montfermeil, 93370, France

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Montgeron, 91230, France

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Montigny-le-Bretonneux, 78180, France

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Montigny-lès-Metz, 57950, France

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Montoire-sur-le-Loir, 41800, France

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Montpellier, 34000, France

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Montpellier, 34080, France

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Montreuil, 93100, France

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Morlaàs, 64160, France

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Morlaix, 29600, France

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Mornas, 84550, France

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Mouans-Sartoux, 06370, France

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Moutiers Tarentaise, 73600, France

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Moyeuvre-Grande, 57250, France

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Mur-de-Sologne, 41230, France

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Nanterre, 92000, France

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Nantes, 44300, France

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Nemours, 77140, France

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Neuville-sur-Saône, 69250, France

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Niort, 79000, France

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Nogent-sur-Marne, 94130, France

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Noisy-le-Roi, 78590, France

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Noyon, 60400, France

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Obernai, 67210, France

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Oloron-Sainte-Marie, 64400, France

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Orléans, 45000, France

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Orléans, 45100, France

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Orthez, 64300, France

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Oucques, 41290, France

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Ouistreham, 14150, France

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Oust, 09140, France

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Ozoir-la-Ferrière, 77330, France

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Palaiseau, 91120, France

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Pamiers, 09100, France

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Paris, 75005, France

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Paris, 75006, France

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Paris, 75008, France

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Paris, 75009, France

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Paris, 75011, France

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Paris, 75012, France

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Paris, 75013, France

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Paris, 75014, France

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Paris, 75015, France

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Paris, 75016, France

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Paris, 75018, France

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Paris, 75020, France

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Paris, France, France

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Pau, 64000, France

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Pau, 64075, France

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Pertuis, 84120, France

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Pierrefitte-sur-Sauldre, 41300, France

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Plouguernével, 22110, France

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Pont Ste Maxence, 60700, France

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Pont-à-Mousson, 54700, France

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Pont-l'Abbé-d'Arnoult, 17250, France

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Pontarlier, 25300, France

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Pornic, 44210, France

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Port-sur-Saône, 70170, France

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Provins, 77160, France

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Publier, 74500, France

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Puteaux, 92800, France

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Quévreville-la-Poterie, 76520, France

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Râches, 59194, France

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Rennes, 35000, France

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Rennes, 35200, France

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Rennes, 35700, France

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Rezé, 44400, France

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Rillieux-la-Pape, 69140, France

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Riom, 63200, France

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Rivery, 80136, France

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Roanne, 42300, France

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Roche-la-Molière, 42230, France

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Rodez, 12000, France

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Romainville, 93230, France

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Romans-sur-Isère, 26100, France

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Romillé, 35850, France

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Ronchin, 59790, France

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Rosières-en-Santerre, 80170, France

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Rouen, 76000, France

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Royan, 17200, France

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Ruy, 38300, France

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Sahurs, 76113, France

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Saint-Astier, 24110, France

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Saint-Aubin, 39410, France

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Saint-Aubin-sur-Scie, 76550, France

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Saint-Brevin-les-Pins, 44250, France

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Saint-Brieuc, 22000, France

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Saint-Chamond, 42400, France

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Saint-Chéron, 91530, France

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Saint-Cloud, 92210, France

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Saint-Cyr-au-Mont-d'Or, 69450, France

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Saint-Denis, 93200, France

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Saint-Etienne, 42100, France

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Saint-Étienne-de-Montluc, 44360, France

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Saint-Flour, 15100, France

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Saint-Genis-Laval, 69230, France

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Saint-Germain-lès-Arpajon, 91180, France

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Saint-Herblain, 44800, France

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Saint-Ismier, 38330, France

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Saint-Jean-de-la-Ruelle, 45140, France

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Saint-Leu-la-Forêt, 95320, France

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Saint-Louis, 68300, France

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Saint-Loup-sur-Semouse, 70800, France

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Saint-Nazaire, 44600, France

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Saint-Pierre-d'Irube, 64990, France

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Saint-Pol-sur-Mer, 59430, France

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Saint-Priest, 69800, France

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Saint-Rémy-de-Provence, 13210, France

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Saint-Tropez, 83990, France

Location

GSK Investigational Site

Saintes, 17100, France

Location

GSK Investigational Site

Sanary-sur-Mer, 83110, France

Location

GSK Investigational Site

Segonzac, 16130, France

Location

GSK Investigational Site

Segré, 49500, France

Location

GSK Investigational Site

Sens, 89100, France

Location

GSK Investigational Site

Septèmes-les-Vallons, 13240, France

Location

GSK Investigational Site

Serres, 05700, France

Location

GSK Investigational Site

Sélestat, 67600, France

Location

GSK Investigational Site

Sillery, 51500, France

Location

GSK Investigational Site

Soissons, 02200, France

Location

GSK Investigational Site

Sorgues, 84700, France

Location

GSK Investigational Site

St-Malo, 35400, France

Location

GSK Investigational Site

St.-Jean, 31240, France

Location

GSK Investigational Site

Ste Foy La Grande, 33220, France

Location

GSK Investigational Site

Ste Maxime, 83120, France

Location

GSK Investigational Site

Strasbourg, 67000, France

Location

GSK Investigational Site

Strasbourg, 67082, France

Location

GSK Investigational Site

Strasbourg, 67100, France

Location

GSK Investigational Site

Sucy-en-Brie, 94370, France

Location

GSK Investigational Site

Suresnes, 92150, France

Location

GSK Investigational Site

Talence, 33400, France

Location

GSK Investigational Site

Tarascon, 13150, France

Location

GSK Investigational Site

Thiais, 94320, France

Location

GSK Investigational Site

Thonon-les-Bains, 74200, France

Location

GSK Investigational Site

Thun-Saint-Amand, 59158, France

Location

GSK Investigational Site

Toul, 54200, France

Location

GSK Investigational Site

Toulon, 83000, France

Location

GSK Investigational Site

Toulon, 83200, France

Location

GSK Investigational Site

Toulouse, 31500, France

Location

GSK Investigational Site

Tours, 37100, France

Location

GSK Investigational Site

Trie-Château, 60590, France

Location

GSK Investigational Site

Troyes, 10000, France

Location

GSK Investigational Site

Vabres-l'Abbaye, 12400, France

Location

GSK Investigational Site

Val-de-Vesle, 51360, France

Location

GSK Investigational Site

Valence, 26000, France

Location

GSK Investigational Site

Vallauris, 06220, France

Location

GSK Investigational Site

Vandœuvre-lès-Nancy, 54500, France

Location

GSK Investigational Site

Vannes, 56000, France

Location

GSK Investigational Site

Vannes, 56034, France

Location

GSK Investigational Site

Vaugneray, 69670, France

Location

GSK Investigational Site

Vaulx-en-Velin, 69120, France

Location

GSK Investigational Site

Vauréal, 95490, France

Location

GSK Investigational Site

Vaux-le-Pénil, 77000, France

Location

GSK Investigational Site

Vendargues, 34740, France

Location

GSK Investigational Site

Vernouillet, 78540, France

Location

GSK Investigational Site

Versailles, 78000, France

Location

GSK Investigational Site

Vertou, 44120, France

Location

GSK Investigational Site

Villars-les-Dombes, 01330, France

Location

GSK Investigational Site

Villeblevin, 89340, France

Location

GSK Investigational Site

Villeneuve-d'Ascq, 59658, France

Location

GSK Investigational Site

Villeurbanne, 69626, France

Location

GSK Investigational Site

Villiers-sur-Marne, 94350, France

Location

GSK Investigational Site

Vincennes, 94300, France

Location

GSK Investigational Site

Viry-Châtillon, 91170, France

Location

GSK Investigational Site

Vitrolles, 13127, France

Location

GSK Investigational Site

Vitry-sur-Seine, 94400, France

Location

GSK Investigational Site

Voreppe, 38340, France

Location

GSK Investigational Site

Wattignies, 59139, France

Location

GSK Investigational Site

Yerres, 91330, France

Location

GSK Investigational Site

Zillisheim, 68720, France

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2013

First Posted

January 28, 2013

Study Start

November 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

February 4, 2013

Record last verified: 2013-01

Locations