Hepatitis B Clinical Trial
— PRALINEOfficial title:
Measurement of the Changes in Acceptability of Hepatitis B Immunization Among General Practitioners and Open-care Paediatricians
| Verified date | January 2013 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Haute Autorité de santé (HAS) |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 474 |
| Est. completion date | April 2012 |
| Est. primary completion date | April 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| France | GSK Investigational Site | Agde cedex | |
| France | GSK Investigational Site | Agen | |
| France | GSK Investigational Site | Agen cedex | |
| France | GSK Investigational Site | Aire sur la lys | |
| France | GSK Investigational Site | Aizenay | |
| France | GSK Investigational Site | Albi | |
| France | GSK Investigational Site | Ales | |
| France | GSK Investigational Site | Alleins | |
| France | GSK Investigational Site | Amiens | |
| France | GSK Investigational Site | Ancenis | |
| France | GSK Investigational Site | Andresy | |
| France | GSK Investigational Site | Angers | |
| France | GSK Investigational Site | Anglet | |
| France | GSK Investigational Site | Annecy | |
| France | GSK Investigational Site | Annecy le vieux | |
| France | GSK Investigational Site | Antony | |
| France | GSK Investigational Site | Argenteuil | |
| France | GSK Investigational Site | Arles | |
| France | GSK Investigational Site | Arnas | |
| France | GSK Investigational Site | Arsac | |
| France | GSK Investigational Site | Asnieres sur seine | |
| France | GSK Investigational Site | Aubagne | |
| France | GSK Investigational Site | Aubergenville | |
| France | GSK Investigational Site | Aubervilliers | |
| France | GSK Investigational Site | Aucamville | |
| France | GSK Investigational Site | Auchy les mines | |
| France | GSK Investigational Site | Auriol | |
| France | GSK Investigational Site | Avignon | |
| France | GSK Investigational Site | Bagneux | |
| France | GSK Investigational Site | Bagnols sur ceze | |
| France | GSK Investigational Site | Bar le duc | |
| France | GSK Investigational Site | Barr | |
| France | GSK Investigational Site | Beaulieu les loches | |
| France | GSK Investigational Site | Beaumont | |
| France | GSK Investigational Site | Beaupreau | |
| France | GSK Investigational Site | Beausoleil | |
| France | GSK Investigational Site | Beauvais | |
| France | GSK Investigational Site | Belfort | |
| France | GSK Investigational Site | Bellegarde | |
| France | GSK Investigational Site | Berre l etang | |
| France | GSK Investigational Site | Besancon | |
| France | GSK Investigational Site | Bethune | |
| France | GSK Investigational Site | Betton | |
| France | GSK Investigational Site | Beziers | |
| France | GSK Investigational Site | Biarritz | |
| France | GSK Investigational Site | Bievres | |
| France | GSK Investigational Site | Biganos | |
| France | GSK Investigational Site | Biscarrosse | |
| France | GSK Investigational Site | Bischheim | |
| France | GSK Investigational Site | Bois guillaume cedex | |
| France | GSK Investigational Site | Bollene | |
| France | GSK Investigational Site | Boos | |
| France | GSK Investigational Site | Bordeaux | |
| France | GSK Investigational Site | Bordeaux | |
| France | GSK Investigational Site | Bosmie l aiguille | |
| France | GSK Investigational Site | Boulogne billancourt | |
| France | GSK Investigational Site | Bourg en bresse | |
| France | GSK Investigational Site | Bousse | |
| France | GSK Investigational Site | Brest | |
| France | GSK Investigational Site | Bron | |
| France | GSK Investigational Site | Bron | |
| France | GSK Investigational Site | Bruges cedex | |
| France | GSK Investigational Site | Buchy | |
| France | GSK Investigational Site | Caen | |
| France | GSK Investigational Site | Cambrai | |
| France | GSK Investigational Site | Camphin en carembault | |
| France | GSK Investigational Site | Cannes | |
| France | GSK Investigational Site | Carresse Cassaber | |
| France | GSK Investigational Site | Caveirac | |
| France | GSK Investigational Site | Cergy | |
| France | GSK Investigational Site | Cergy st christophe | |
| France | GSK Investigational Site | Cestas | |
| France | GSK Investigational Site | Chalamont | |
| France | GSK Investigational Site | Challans | |
| France | GSK Investigational Site | Chalon sur saone | |
| France | GSK Investigational Site | Chambly | |
| France | GSK Investigational Site | Champigny sur marne | |
| France | GSK Investigational Site | Chanteloup les vignes | |
| France | GSK Investigational Site | Chantilly | |
| France | GSK Investigational Site | Chartres | |
| France | GSK Investigational Site | Chassieu | |
| France | GSK Investigational Site | Chateauneuf les martigues | |
| France | GSK Investigational Site | Chatenois les forges | |
| France | GSK Investigational Site | Chatou | |
| France | GSK Investigational Site | Cherbourg - octeville | |
| France | GSK Investigational Site | Clamart | |
| France | GSK Investigational Site | Clapiers | |
| France | GSK Investigational Site | Clermont Ferrand | |
| France | GSK Investigational Site | Clermont ferrand | |
| France | GSK Investigational Site | Clichy | |
| France | GSK Investigational Site | Colmar | |
| France | GSK Investigational Site | Colomars | |
| France | GSK Investigational Site | Colombelles | |
| France | GSK Investigational Site | Combs la ville | |
| France | GSK Investigational Site | Compiegne | |
| France | GSK Investigational Site | Conde sur noireau | |
| France | GSK Investigational Site | Corbeil essonnes | |
| France | GSK Investigational Site | Courpiere | |
| France | GSK Investigational Site | Creutzwald | |
| France | GSK Investigational Site | Crolles | |
| France | GSK Investigational Site | Cugnaux | |
| France | GSK Investigational Site | Cusset | |
| France | GSK Investigational Site | Darnetal | |
| France | GSK Investigational Site | Deluz | |
| France | GSK Investigational Site | Dessenheim | |
| France | GSK Investigational Site | Digne les bains | |
| France | GSK Investigational Site | Divonne les bains | |
| France | GSK Investigational Site | Domene | |
| France | GSK Investigational Site | Domont | |
| France | GSK Investigational Site | Draguignan | |
| France | GSK Investigational Site | Einvaux | |
| France | GSK Investigational Site | Epinal cedex 9 | |
| France | GSK Investigational Site | Equeurdreville hainneville | |
| France | GSK Investigational Site | Esquerdes | |
| France | GSK Investigational Site | Essey les Nancy | |
| France | GSK Investigational Site | Estrees st denis | |
| France | GSK Investigational Site | Evreux | |
| France | GSK Investigational Site | Evry | |
| France | GSK Investigational Site | Fecamp | |
| France | GSK Investigational Site | Fenioux | |
| France | GSK Investigational Site | Feurs | |
| France | GSK Investigational Site | Figeac | |
| France | GSK Investigational Site | Fontaine | |
| France | GSK Investigational Site | Fontaine les dijon | |
| France | GSK Investigational Site | Fontains | |
| France | GSK Investigational Site | Fontenay sous bois | |
| France | GSK Investigational Site | Forges les eaux | |
| France | GSK Investigational Site | Fouesnant | |
| France | GSK Investigational Site | Foussais payre | |
| France | GSK Investigational Site | Francheville | |
| France | GSK Investigational Site | Fumel | |
| France | GSK Investigational Site | Gamarde les bains | |
| France | GSK Investigational Site | Gemozac | |
| France | GSK Investigational Site | Gondecourt | |
| France | GSK Investigational Site | Gonneville la mallet | |
| France | GSK Investigational Site | Gouvieux | |
| France | GSK Investigational Site | Gouy sous bellonne | |
| France | GSK Investigational Site | Gouzeaucourt | |
| France | GSK Investigational Site | Grenoble | |
| France | GSK Investigational Site | Greoux les bains | |
| France | GSK Investigational Site | Grigny | |
| France | GSK Investigational Site | Guenange | |
| France | GSK Investigational Site | Haguenau | |
| France | GSK Investigational Site | Hatten | |
| France | GSK Investigational Site | Hesdin | |
| France | GSK Investigational Site | Hoenheim | |
| France | GSK Investigational Site | Houilles | |
| France | GSK Investigational Site | Houplin ancoisne | |
| France | GSK Investigational Site | Hyeres | |
| France | GSK Investigational Site | Illkirch graffenstaden | |
| France | GSK Investigational Site | Istres | |
| France | GSK Investigational Site | Jarny | |
| France | GSK Investigational Site | Joue les tours | |
| France | GSK Investigational Site | L aigle | |
| France | GSK Investigational Site | L huisserie | |
| France | GSK Investigational Site | La chapelle sur erdre | |
| France | GSK Investigational Site | La couronne | |
| France | GSK Investigational Site | La creche | |
| France | GSK Investigational Site | La garenne colombes | |
| France | GSK Investigational Site | La madeleine | |
| France | GSK Investigational Site | La meziere | |
| France | GSK Investigational Site | La motte servolex | |
| France | GSK Investigational Site | La source orleans | |
| France | GSK Investigational Site | La talaudiere | |
| France | GSK Investigational Site | La voulte sur rhone | |
| France | GSK Investigational Site | Lamarche sur saone | |
| France | GSK Investigational Site | Lambersart | |
| France | GSK Investigational Site | Landivisiau | |
| France | GSK Investigational Site | Lanester | |
| France | GSK Investigational Site | Langon | |
| France | GSK Investigational Site | Laval | |
| France | GSK Investigational Site | Le barp | |
| France | GSK Investigational Site | Le Bouscat | |
| France | GSK Investigational Site | Le cannet | |
| France | GSK Investigational Site | Le chesnay | |
| France | GSK Investigational Site | Le creusot | |
| France | GSK Investigational Site | Le havre | |
| France | GSK Investigational Site | Le kremlin bicetre | |
| France | GSK Investigational Site | Le lavandou | |
| France | GSK Investigational Site | Le palais sur vienne | |
| France | GSK Investigational Site | Le passage d' agen | |
| France | GSK Investigational Site | Le rheu | |
| France | GSK Investigational Site | Les sables d olonne | |
| France | GSK Investigational Site | Les Sables D'olonne | |
| France | GSK Investigational Site | Les ulis | |
| France | GSK Investigational Site | Lesquin | |
| France | GSK Investigational Site | Lille Cedex | |
| France | GSK Investigational Site | Limas | |
| France | GSK Investigational Site | Limoges | |
| France | GSK Investigational Site | Lingolsheim | |
| France | GSK Investigational Site | Lisieux | |
| France | GSK Investigational Site | Lognes | |
| France | GSK Investigational Site | Lomme | |
| France | GSK Investigational Site | Loos en gohelle | |
| France | GSK Investigational Site | Lorient | |
| France | GSK Investigational Site | Luzinay | |
| France | GSK Investigational Site | Lyon | |
| France | GSK Investigational Site | Lyon | |
| France | GSK Investigational Site | Lyon | |
| France | GSK Investigational Site | Lyon | |
| France | GSK Investigational Site | Malakoff | |
| France | GSK Investigational Site | Mantes la ville | |
| France | GSK Investigational Site | Marchenoir | |
| France | GSK Investigational Site | Marcq en baroeul | |
| France | GSK Investigational Site | Marguerittes | |
| France | GSK Investigational Site | Marmande | |
| France | GSK Investigational Site | Marnay | |
| France | GSK Investigational Site | Marseille | |
| France | GSK Investigational Site | Marseille | |
| France | GSK Investigational Site | Marseille | |
| France | GSK Investigational Site | Marseille | |
| France | GSK Investigational Site | Marseille | |
| France | GSK Investigational Site | Marseille | |
| France | GSK Investigational Site | Martigues | |
| France | GSK Investigational Site | Martin eglise | |
| France | GSK Investigational Site | Martinsart | |
| France | GSK Investigational Site | Mauze sur mignon | |
| France | GSK Investigational Site | Meaux | |
| France | GSK Investigational Site | Merignac | |
| France | GSK Investigational Site | Merkwiller pechelbronn | |
| France | GSK Investigational Site | Mery sur oise | |
| France | GSK Investigational Site | Metz | |
| France | GSK Investigational Site | Meudon | |
| France | GSK Investigational Site | Meylan | |
| France | GSK Investigational Site | Meyssac | |
| France | GSK Investigational Site | Mirecourt | |
| France | GSK Investigational Site | Moivrons | |
| France | GSK Investigational Site | Molsheim | |
| France | GSK Investigational Site | Mondeville | |
| France | GSK Investigational Site | Mons en baroeul | |
| France | GSK Investigational Site | Montauban | |
| France | GSK Investigational Site | Montelimar | |
| France | GSK Investigational Site | Monteux | |
| France | GSK Investigational Site | Montfermeil | |
| France | GSK Investigational Site | Montgeron | |
| France | GSK Investigational Site | Montigny le bretonneux | |
| France | GSK Investigational Site | Montigny les metz | |
| France | GSK Investigational Site | Montoire sur le loir | |
| France | GSK Investigational Site | Montpellier | |
| France | GSK Investigational Site | Montpellier | |
| France | GSK Investigational Site | Montreuil | |
| France | GSK Investigational Site | Morlaas | |
| France | GSK Investigational Site | Morlaix | |
| France | GSK Investigational Site | Mornas | |
| France | GSK Investigational Site | Mouans sartoux | |
| France | GSK Investigational Site | Moutiers tarentaise | |
| France | GSK Investigational Site | Moyeuvre grande | |
| France | GSK Investigational Site | Mur de sologne | |
| France | GSK Investigational Site | Nanterre | |
| France | GSK Investigational Site | Nantes | |
| France | GSK Investigational Site | Nemours | |
| France | GSK Investigational Site | Neuville sur saone | |
| France | GSK Investigational Site | Niort | |
| France | GSK Investigational Site | Nogent sur marne | |
| France | GSK Investigational Site | Noisy le roi | |
| France | GSK Investigational Site | Noyon | |
| France | GSK Investigational Site | Obernai | |
| France | GSK Investigational Site | Oloron ste marie | |
| France | GSK Investigational Site | Orleans | |
| France | GSK Investigational Site | Orleans | |
| France | GSK Investigational Site | Orthez | |
| France | GSK Investigational Site | Oucques | |
| France | GSK Investigational Site | Ouistreham | |
| France | GSK Investigational Site | Oust | |
| France | GSK Investigational Site | Ozoir la ferriere | |
| France | GSK Investigational Site | Palaiseau | |
| France | GSK Investigational Site | Pamiers | |
| France | GSK Investigational Site | Paris | |
| France | GSK Investigational Site | Paris | |
| France | GSK Investigational Site | Paris | |
| France | GSK Investigational Site | Paris | |
| France | GSK Investigational Site | Paris | |
| France | GSK Investigational Site | Paris | |
| France | GSK Investigational Site | Paris | |
| France | GSK Investigational Site | Paris | |
| France | GSK Investigational Site | Paris | |
| France | GSK Investigational Site | Paris | |
| France | GSK Investigational Site | Paris | |
| France | GSK Investigational Site | Paris | |
| France | GSK Investigational Site | Paris | |
| France | GSK Investigational Site | Pau | |
| France | GSK Investigational Site | Pau cedex | |
| France | GSK Investigational Site | Pertuis | |
| France | GSK Investigational Site | Pierrefitte sur sauldre | |
| France | GSK Investigational Site | Plouguernevel | |
| France | GSK Investigational Site | Pont a mousson | |
| France | GSK Investigational Site | Pont l abbe d arnoult | |
| France | GSK Investigational Site | Pont ste maxence | |
| France | GSK Investigational Site | Pontarlier | |
| France | GSK Investigational Site | Pornic | |
| France | GSK Investigational Site | Port sur saone | |
| France | GSK Investigational Site | Provins | |
| France | GSK Investigational Site | Publier | |
| France | GSK Investigational Site | Puteaux | |
| France | GSK Investigational Site | Quevreville la poterie | |
| France | GSK Investigational Site | Raches | |
| France | GSK Investigational Site | Rennes | |
| France | GSK Investigational Site | Rennes | |
| France | GSK Investigational Site | Rennes | |
| France | GSK Investigational Site | Reze | |
| France | GSK Investigational Site | Rillieux la pape | |
| France | GSK Investigational Site | Riom | |
| France | GSK Investigational Site | Rivery | |
| France | GSK Investigational Site | Roanne | |
| France | GSK Investigational Site | Roche la moliere | |
| France | GSK Investigational Site | Rodez | |
| France | GSK Investigational Site | Romainville | |
| France | GSK Investigational Site | Romans sur isere | |
| France | GSK Investigational Site | Romille | |
| France | GSK Investigational Site | Ronchin | |
| France | GSK Investigational Site | Rosieres en santerre | |
| France | GSK Investigational Site | Rouen | |
| France | GSK Investigational Site | Royan | |
| France | GSK Investigational Site | Ruy | |
| France | GSK Investigational Site | Sahurs | |
| France | GSK Investigational Site | Saint-Aubin | |
| France | GSK Investigational Site | Saintes | |
| France | GSK Investigational Site | Sanary sur mer | |
| France | GSK Investigational Site | Segonzac | |
| France | GSK Investigational Site | Segré | |
| France | GSK Investigational Site | Selestat | |
| France | GSK Investigational Site | Sens | |
| France | GSK Investigational Site | Septemes les vallons | |
| France | GSK Investigational Site | Serres | |
| France | GSK Investigational Site | Sillery | |
| France | GSK Investigational Site | Soissons | |
| France | GSK Investigational Site | Sorgues | |
| France | GSK Investigational Site | St astier | |
| France | GSK Investigational Site | St aubin sur scie | |
| France | GSK Investigational Site | St brevin les pins | |
| France | GSK Investigational Site | St brieuc | |
| France | GSK Investigational Site | St chamond | |
| France | GSK Investigational Site | St cheron | |
| France | GSK Investigational Site | St cloud | |
| France | GSK Investigational Site | St cyr au mont d'or | |
| France | GSK Investigational Site | St denis | |
| France | GSK Investigational Site | St etienne | |
| France | GSK Investigational Site | St etienne de montluc | |
| France | GSK Investigational Site | St flour | |
| France | GSK Investigational Site | St genis laval | |
| France | GSK Investigational Site | St germain les arpajon | |
| France | GSK Investigational Site | St herblain | |
| France | GSK Investigational Site | St ismier | |
| France | GSK Investigational Site | St jean | |
| France | GSK Investigational Site | St jean de la ruelle | |
| France | GSK Investigational Site | St leu la foret | |
| France | GSK Investigational Site | St louis | |
| France | GSK Investigational Site | St loup sur semouse | |
| France | GSK Investigational Site | St malo | |
| France | GSK Investigational Site | St nazaire | |
| France | GSK Investigational Site | St pierre d irube | |
| France | GSK Investigational Site | St pol sur mer | |
| France | GSK Investigational Site | St priest | |
| France | GSK Investigational Site | St remy de provence | |
| France | GSK Investigational Site | St tropez | |
| France | GSK Investigational Site | Ste foy la grande | |
| France | GSK Investigational Site | Ste maxime | |
| France | GSK Investigational Site | Strasbourg | |
| France | GSK Investigational Site | Strasbourg | |
| France | GSK Investigational Site | Strasbourg cedex | |
| France | GSK Investigational Site | Sucy en brie | |
| France | GSK Investigational Site | Suresnes | |
| France | GSK Investigational Site | Talence | |
| France | GSK Investigational Site | Tarascon | |
| France | GSK Investigational Site | Thiais | |
| France | GSK Investigational Site | Thonon les bains | |
| France | GSK Investigational Site | Thun st amand | |
| France | GSK Investigational Site | Toul | |
| France | GSK Investigational Site | Toulon | |
| France | GSK Investigational Site | Toulon | |
| France | GSK Investigational Site | Toulouse | |
| France | GSK Investigational Site | Tours | |
| France | GSK Investigational Site | Trie chateau | |
| France | GSK Investigational Site | Troyes | |
| France | GSK Investigational Site | Vabres l abbaye | |
| France | GSK Investigational Site | Val de vesle | |
| France | GSK Investigational Site | Valence | |
| France | GSK Investigational Site | Vallauris | |
| France | GSK Investigational Site | Vandoeuvre les nancy | |
| France | GSK Investigational Site | Vannes | |
| France | GSK Investigational Site | Vannes cedex | |
| France | GSK Investigational Site | Vaugneray | |
| France | GSK Investigational Site | Vaulx en velin | |
| France | GSK Investigational Site | Vaureal | |
| France | GSK Investigational Site | Vaux le penil | |
| France | GSK Investigational Site | Vendargues | |
| France | GSK Investigational Site | Vernouillet | |
| France | GSK Investigational Site | Versailles | |
| France | GSK Investigational Site | Vertou | |
| France | GSK Investigational Site | Villars les Dombes | |
| France | GSK Investigational Site | Villeblevin | |
| France | GSK Investigational Site | Villeneuve d ascq cedex | |
| France | GSK Investigational Site | Villeurbanne cedex | |
| France | GSK Investigational Site | Villiers sur marne | |
| France | GSK Investigational Site | Vincennes | |
| France | GSK Investigational Site | Viry chatillon | |
| France | GSK Investigational Site | Vitrolles | |
| France | GSK Investigational Site | Vitry sur Seine | |
| France | GSK Investigational Site | Voreppe | |
| France | GSK Investigational Site | Wattignies | |
| France | GSK Investigational Site | Yerres | |
| France | GSK Investigational Site | Zillisheim |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in the proportion of physicians with at least 50% of infants immunized against Hepatitis B. | 4 years | No | |
| Secondary | Type of physicians, based on the questionnaire regarding immunization practices and established at each measurement time point. | 4 years | No |
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