Hepatitis BPRALINENCT01777074

Acceptability of Hepatitis B Vaccination in General Practitioners and Paediatricians

An observational study of Hepatitis B, run by GlaxoSmithKline at 402 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Hepatitis B
What is being tested?: Data collection
Type of treatment: Vaccines
How many people: 474 participants
Where: 402 sitesFrance
Study dates: Nov 2009to Apr 2012
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

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.

Who may be able to join

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).

Who cannot join

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

Trial locations and contacts

402 sites in 1 country.

City, postcode or hospital

300 sites in 1 country

France300 sites

GSK Investigational Site
Agde, 34303
GSK Investigational Site
Agen, 47000
GSK Investigational Site
Agen, 47002
GSK Investigational Site
Aire-sur-la-Lys, 62120
GSK Investigational Site
Aizenay, 85190
GSK Investigational Site
Albi, 81000
GSK Investigational Site
Alès, 30100
GSK Investigational Site
Alleins, 13980
GSK Investigational Site
Amiens, 80080
GSK Investigational Site
Ancenis, 44150
GSK Investigational Site
Andrésy, 78570
GSK Investigational Site
Angers, 49000
GSK Investigational Site
Anglet, 64600
GSK Investigational Site
Annecy, 74000
GSK Investigational Site
Annecy-le-Vieux, 74940
GSK Investigational Site
Antony, 92160
GSK Investigational Site
Argenteuil, 95100
GSK Investigational Site
Arles, 13200
GSK Investigational Site
Arnas, 69400
GSK Investigational Site
Arsac, 33460
GSK Investigational Site
Asnières-sur-Seine, 92600
GSK Investigational Site
Aubagne, 13400
GSK Investigational Site
Aubergenville, 78410
GSK Investigational Site
Aubervilliers, 93300
GSK Investigational Site
Aucamville, 31140
GSK Investigational Site
Auchy-les-Mines, 62138
GSK Investigational Site
Auriol, 13390
GSK Investigational Site
Avignon, 84000
GSK Investigational Site
Bagneux, 92220
GSK Investigational Site
Bagnols-sur-Cèze, 30200
GSK Investigational Site
Bar-le-Duc, 55000
GSK Investigational Site
Barr, 67140
GSK Investigational Site
Beaulieu-lès-Loches, 37600
GSK Investigational Site
Beaumont, 63110
GSK Investigational Site
Beaupréau, 49600
GSK Investigational Site
Beausoleil, 06240
GSK Investigational Site
Beauvais, 60000
GSK Investigational Site
Belfort, 90000
GSK Investigational Site
Bellegarde, 30127
GSK Investigational Site
Berre-l'Étang, 13130
GSK Investigational Site
Besançon, 25000
GSK Investigational Site
Béthune, 62400
GSK Investigational Site
Betton, 35830
GSK Investigational Site
Béziers, 34500
GSK Investigational Site
Biarritz, 64200
GSK Investigational Site
Bièvres, 91570
GSK Investigational Site
Biganos, 33380
GSK Investigational Site
Biscarrosse, 40600
GSK Investigational Site
Bischheim, 67800
GSK Investigational Site
Bois-Guillaume, 76235
GSK Investigational Site
Bollène, 84500
GSK Investigational Site
Boos, 76520
GSK Investigational Site
Bordeaux, 33200
GSK Investigational Site
Bordeaux, 33300
GSK Investigational Site
Bosmie-l'Aiguille, 87110
GSK Investigational Site
Boulogne-Billancourt, 92100
GSK Investigational Site
Bourg-en-Bresse, 01000
GSK Investigational Site
Bousse, 57310
GSK Investigational Site
Brest, 29200
GSK Investigational Site
Bron, 69500
GSK Investigational Site
Bron, 69677
GSK Investigational Site
Bruges, 33520
GSK Investigational Site
Buchy, 76750
GSK Investigational Site
Caen, 14000
GSK Investigational Site
Cambrai, 59400
GSK Investigational Site
Camphin-en-Carembault, 59133
GSK Investigational Site
Cannes, 06400
GSK Investigational Site
Carresse-Cassaber, 64270
GSK Investigational Site
Caveirac, 30820
GSK Investigational Site
Cergy, 95000
GSK Investigational Site
Cergy Saint Christophe, 95800
GSK Investigational Site
Cestas, 33610
GSK Investigational Site
Chalamont, 01320
GSK Investigational Site
Challans, 85300
GSK Investigational Site
Chalon-sur-Saône, 71100
GSK Investigational Site
Chambly, 60230
GSK Investigational Site
Champigny-sur-Marne, 94500
GSK Investigational Site
Chanteloup-les-Vignes, 78570
GSK Investigational Site
Chantilly, 60500
GSK Investigational Site
Chartres, 28000
GSK Investigational Site
Chassieu, 69680
GSK Investigational Site
Châteauneuf-les-Martigues, 13220
GSK Investigational Site
Châtenois-les-Forges, 90700
GSK Investigational Site
Chatou, 78400
GSK Investigational Site
Cherbourg - Octeville, 50130
GSK Investigational Site
Clamart, 92140
GSK Investigational Site
Clapiers, 34830
GSK Investigational Site
Clermont-Ferrand, 63000
GSK Investigational Site
Clermont-Ferrand, 63100
GSK Investigational Site
Clichy, 92110
GSK Investigational Site
Colmar, 68000
GSK Investigational Site
Colomars, 06670
GSK Investigational Site
Colombelles, 14460
GSK Investigational Site
Combs-la-Ville, 77380
GSK Investigational Site
Compiègne, 60200
GSK Investigational Site
Condé-sur-Noireau, 14110
GSK Investigational Site
Corbeil-Essonnes, 91100
GSK Investigational Site
Courpière, 63120
GSK Investigational Site
Creutzwald, 57150
GSK Investigational Site
Crolles, 38920
GSK Investigational Site
Cugnaux, 31270
GSK Investigational Site
Cusset, 03300
GSK Investigational Site
Darnétal, 76160
GSK Investigational Site
Deluz, 25960
GSK Investigational Site
Dessenheim, 68600
GSK Investigational Site
Digne-les-Bains, 04000
GSK Investigational Site
Divonne-les-Bains, 01220
GSK Investigational Site
Domène, 38420
GSK Investigational Site
Domont, 95330
GSK Investigational Site
Draguignan, 83300
GSK Investigational Site
Einvaux, 54360
GSK Investigational Site
Épinal, 88051
GSK Investigational Site
Équeurdreville-Hainneville, 50120
GSK Investigational Site
Esquerdes, 62380
GSK Investigational Site
Essey-lès-Nancy, 54270
GSK Investigational Site
Estrées-Saint-Denis, 60190
GSK Investigational Site
Évreux, 13500
GSK Investigational Site
Évry, 91000
GSK Investigational Site
Fécamp, 76400
GSK Investigational Site
Fenioux, 79160
GSK Investigational Site
Feurs, 42110
GSK Investigational Site
Figeac, 46100
GSK Investigational Site
Fontaine, 38600
GSK Investigational Site
Fontaine-lès-Dijon, 21121
GSK Investigational Site
Fontains, 77370
GSK Investigational Site
Fontenay-sous-Bois, 94120
GSK Investigational Site
Forges-les-Eaux, 76440
GSK Investigational Site
Fouesnant, 29170
GSK Investigational Site
Foussais-Payré, 85240
GSK Investigational Site
Francheville, 69340
GSK Investigational Site
Fumel, 47500
GSK Investigational Site
Gamarde-les-Bains, 40380
GSK Investigational Site
Gémozac, 17260
GSK Investigational Site
Gondecourt, 59147
GSK Investigational Site
Gonneville-la-Mallet, 76280
GSK Investigational Site
Gouvieux, 60270
GSK Investigational Site
Gouy-sous-Bellonne, 62112
GSK Investigational Site
Gouzeaucourt, 59231
GSK Investigational Site
Grenoble, 38000
GSK Investigational Site
Gréoux-les-Bains, 04800
GSK Investigational Site
Grigny, 91350
GSK Investigational Site
Guénange, 57310
GSK Investigational Site
Haguenau, 67500
GSK Investigational Site
Hatten, 67690
GSK Investigational Site
Hesdin, 62140
GSK Investigational Site
Hœnheim, 67800
GSK Investigational Site
Houilles, 78800
GSK Investigational Site
Houplin-Ancoisne, 59263
GSK Investigational Site
Hyères, 83400
GSK Investigational Site
Illkirch-Graffenstaden, 67400
GSK Investigational Site
Istres, 13800
GSK Investigational Site
Jarny, 54800
GSK Investigational Site
Joué-lès-Tours, 37300
GSK Investigational Site
L'Aigle, 61300
GSK Investigational Site
L'Huisserie, 53970
GSK Investigational Site
La Chapelle-sur-Erdre, 44240
GSK Investigational Site
La Couronne, 16400
GSK Investigational Site
La Crèche, 79260
GSK Investigational Site
La Garenne-Colombes, 92250
GSK Investigational Site
La Madeleine, 59110
GSK Investigational Site
La Mézière, 35520
GSK Investigational Site
La Motte-Servolex, 73290
GSK Investigational Site
La Source Orleans, 45100
GSK Investigational Site
La Talaudière, 42350
GSK Investigational Site
La Voulte-sur-Rhône, 07800
GSK Investigational Site
Lamarche-sur-Saône, 21760
GSK Investigational Site
Lambersart, 59130
GSK Investigational Site
Landivisiau, 29400
GSK Investigational Site
Lanester, 56600
GSK Investigational Site
Langon, 33210
GSK Investigational Site
Laval, 53000
GSK Investigational Site
Le Barp, 33114
GSK Investigational Site
Le Bouscat, 33110
GSK Investigational Site
Le Cannet, 06110
GSK Investigational Site
Le Chesnay, 78150
GSK Investigational Site
Le Creusot, 71200
GSK Investigational Site
Le Havre, 76600
GSK Investigational Site
Le Kremlin-Bicêtre, 94270
GSK Investigational Site
Le Lavandou, 83980
GSK Investigational Site
Le Palais-sur-Vienne, 87410
GSK Investigational Site
Le Passage D' Agen, 47520
GSK Investigational Site
Le Rheu, 35650
GSK Investigational Site
Les Sables-d'Olonne, 85100
GSK Investigational Site
Les Sables-d'Olonne
GSK Investigational Site
Les Ulis, 91940
GSK Investigational Site
Lesquin, 59810
GSK Investigational Site
Lille, 59020
GSK Investigational Site
Limas, 69400
GSK Investigational Site
Limoges, 87000
GSK Investigational Site
Lingolsheim, 67380
GSK Investigational Site
Lisieux, 14100
GSK Investigational Site
Lognes, 77185
GSK Investigational Site
Lomme, 59160
GSK Investigational Site
Loos-en-Gohelle, 62750
GSK Investigational Site
Lorient, 56100
GSK Investigational Site
Luzinay, 38200
GSK Investigational Site
Lyon, 69001
GSK Investigational Site
Lyon, 69003
GSK Investigational Site
Lyon, 69007
GSK Investigational Site
Lyon, 69008
GSK Investigational Site
Malakoff, 92240
GSK Investigational Site
Mantes-la-Ville, 78711
GSK Investigational Site
Marchenoir, 41370
GSK Investigational Site
Marcq-en-Barœul, 59700
GSK Investigational Site
Marguerittes, 30320
GSK Investigational Site
Marmande, 47200
GSK Investigational Site
Marnay, 70150
GSK Investigational Site
Marseille, 13005
GSK Investigational Site
Marseille, 13007
GSK Investigational Site
Marseille, 13008
GSK Investigational Site
Marseille, 13009
GSK Investigational Site
Marseille, 13012
GSK Investigational Site
Marseille, 13015
GSK Investigational Site
Martigues, 13500
GSK Investigational Site
Martin-Église, 76370
GSK Investigational Site
Martinsart, 59113
GSK Investigational Site
Mauze Sur Mignon, 79210
GSK Investigational Site
Meaux, 77100
GSK Investigational Site
Mérignac, 33700
GSK Investigational Site
Merkwiller-Pechelbronn, 67250
GSK Investigational Site
Méry-sur-Oise, 95540
GSK Investigational Site
Metz, 57070
GSK Investigational Site
Meudon, 92360
GSK Investigational Site
Meylan, 38240
GSK Investigational Site
Meyssac, 19500
GSK Investigational Site
Mirecourt, 88500
GSK Investigational Site
Moivrons, 54760
GSK Investigational Site
Molsheim, 67120
GSK Investigational Site
Mondeville, 14120
GSK Investigational Site
Mons-en-Barœul, 59370
GSK Investigational Site
Montauban, 82000
GSK Investigational Site
Montélimar, 26200
GSK Investigational Site
Monteux, 84170
GSK Investigational Site
Montfermeil, 93370
GSK Investigational Site
Montgeron, 91230
GSK Investigational Site
Montigny-le-Bretonneux, 78180
GSK Investigational Site
Montigny-lès-Metz, 57950
GSK Investigational Site
Montoire-sur-le-Loir, 41800
GSK Investigational Site
Montpellier, 34000
GSK Investigational Site
Montpellier, 34080
GSK Investigational Site
Montreuil, 93100
GSK Investigational Site
Morlaàs, 64160
GSK Investigational Site
Morlaix, 29600
GSK Investigational Site
Mornas, 84550
GSK Investigational Site
Mouans-Sartoux, 06370
GSK Investigational Site
Moutiers Tarentaise, 73600
GSK Investigational Site
Moyeuvre-Grande, 57250
GSK Investigational Site
Mur-de-Sologne, 41230
GSK Investigational Site
Nanterre, 92000
GSK Investigational Site
Nantes, 44300
GSK Investigational Site
Nemours, 77140
GSK Investigational Site
Neuville-sur-Saône, 69250
GSK Investigational Site
Niort, 79000
GSK Investigational Site
Nogent-sur-Marne, 94130
GSK Investigational Site
Noisy-le-Roi, 78590
GSK Investigational Site
Noyon, 60400
GSK Investigational Site
Obernai, 67210
GSK Investigational Site
Oloron-Sainte-Marie, 64400
GSK Investigational Site
Orléans, 45000
GSK Investigational Site
Orléans, 45100
GSK Investigational Site
Orthez, 64300
GSK Investigational Site
Oucques, 41290
GSK Investigational Site
Ouistreham, 14150
GSK Investigational Site
Oust, 09140
GSK Investigational Site
Ozoir-la-Ferrière, 77330
GSK Investigational Site
Palaiseau, 91120
GSK Investigational Site
Pamiers, 09100
GSK Investigational Site
Paris, 75005
GSK Investigational Site
Paris, 75006
GSK Investigational Site
Paris, 75008
GSK Investigational Site
Paris, 75009
GSK Investigational Site
Paris, 75011
GSK Investigational Site
Paris, 75012
GSK Investigational Site
Paris, 75013
GSK Investigational Site
Paris, 75014
GSK Investigational Site
Paris, 75015
GSK Investigational Site
Paris, 75016
GSK Investigational Site
Paris, 75018
GSK Investigational Site
Paris, 75020
GSK Investigational Site
Paris, France
GSK Investigational Site
Pau, 64000
GSK Investigational Site
Pau, 64075
GSK Investigational Site
Pertuis, 84120
GSK Investigational Site
Pierrefitte-sur-Sauldre, 41300
GSK Investigational Site
Plouguernével, 22110
GSK Investigational Site
Pont Ste Maxence, 60700
GSK Investigational Site
Pont-à-Mousson, 54700
GSK Investigational Site
Pont-l'Abbé-d'Arnoult, 17250
GSK Investigational Site
Pontarlier, 25300
GSK Investigational Site
Pornic, 44210
GSK Investigational Site
Port-sur-Saône, 70170
GSK Investigational Site
Provins, 77160
GSK Investigational Site
Publier, 74500
GSK Investigational Site
Puteaux, 92800
GSK Investigational Site
Quévreville-la-Poterie, 76520
GSK Investigational Site
Râches, 59194
GSK Investigational Site
Rennes, 35000
GSK Investigational Site
Rennes, 35200
GSK Investigational Site
Rennes, 35700
GSK Investigational Site
Rezé, 44400

Other trials in France

About this study

Official title: Measurement of the Changes in Acceptability of Hepatitis B Immunization Among General Practitioners and Open-care Paediatricians

Read the detailed description

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.

Conditions: Hepatitis B
Being tested: Data collection
Keywords: Vaccination, Acceptability, Hepatitis B
Medical subject headings: Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Data collectionOther
Questionnaire, Vaccination book

Study groups in NCT01777074
Study group	Role	What they receive
Generalist physicians Cohort		Not described Receives: Other: Data collection
Paediatricians Cohort		Not described Receives: Other: Data collection

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the proportion of physicians with at least 50% of infants immunized against Hepatitis B.
Measured: 4 years

Secondary outcomes (1)

Type of physicians, based on the questionnaire regarding immunization practices and established at each measurement time point.
Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Apr 2012

First posted28 Jan 2013 (estimated)
Study startNov 2009
Primary completionApr 2012
Study completionApr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hepatitis BStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 474 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01777074
Sponsor's protocol ID: 113385
Acronym: PRALINE
Status last verified: Jan 2013
First submitted: 24 Jan 2013
Last updated: 4 Feb 2013
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

All Hepatitis B trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Measurement of the Changes in Acceptability of Hepatitis B Immunization Among General Practitioners and Open-care Paediatricians
ClinicalTrials.gov ID: NCT01777074
Acronym / sponsor ID: PRALINE / 113385
Conditions: Hepatitis B
Keywords: Vaccination, Acceptability, Hepatitis B
Study type: Observational
Recruitment status: Completed
Enrolment: 474 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 28 Jan 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
Generalist physicians Cohort	–	Other: Data collection
Paediatricians Cohort	–	Other: Data collection

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (1 listed)

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).

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Data collectionQuestionnaire, Vaccination book	Other	Generalist physicians Cohort, Paediatricians Cohort

Primary outcome

Change in the proportion of physicians with at least 50% of infants immunized against Hepatitis B.
Time frame: 4 years

1 secondary outcome

Type of physicians, based on the questionnaire regarding immunization practices and established at each measurement time point.
Time frame: 4 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.

Related trials for Hepatitis B

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

402 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis B, run by GlaxoSmithKline at 402 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 402 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the proportion of physicians with at least 50% of infants immunized against Hepatitis B. (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01777074.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2013.