Last updated: 11/07/2018 06:00:34
Acceptability of Hepatitis B vaccination in General practitioners and PaediatriciansPRALINE
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Measurement of the changes in acceptability of hepatitis B immunization among general practitioners and open-care paediatricians
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Change in the proportion of physicians with at least 50% of infants immunized against Hepatitis B.
Timeframe: 4 years
Secondary outcomes:
Type of physicians, based on the questionnaire regarding immunization practices and established at each measurement time point.
Timeframe: 4 years
Interventions:
Other: Data collection
Enrollment:
474
Observational study model:
Cohort
Primary completion date:
2012-06-04
Time perspective:
Cross-Sectional
Clinical publications:
Vié le Sage F et al. (2016) Public health impact of Infanrix hexa™ (DTPa-HBV-IPV/Hib) reimbursement: A study programme in France. Part 2: Evolution of the acceptability of infants' vaccination against hepatitis B in general and pediatric practices - the PRALINE study. Rev Epidemiol Sante Publique. 64(3):185-194. doi: 10.1016/j.respe.2015.12.019.
Medical condition
Hepatitis B
Product
GSK2197870A, SB213501
Collaborators
Not applicable
Study date(s)
November 2009 to April 2012
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
Yes
- 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).
- Children on the eligibility register not complying with the investigator's immunization policy.
- Refusal of the patient.
Inclusion and exclusion criteria
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:
- Refusal of the patient.
Children on the eligibility register not complying with the investigator's immunization policy.
Trial location(s)
Location
GSK Investigational Site
La voulte sur rhone, France, 07800
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Montigny le bretonneux, France, 78180
Status
Terminated/Withdrawn
Location
GSK Investigational Site
St brevin les pins, France, 44250
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bosmie l aiguille, France, 87110
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Le kremlin bicetre, France, 94270
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Cergy st christophe, France, 95800
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Septemes les vallons, France, 13240
Status
Terminated/Withdrawn
Location
GSK Investigational Site
St pierre d irube, France, 64990
Status
Terminated/Withdrawn
Location
GSK Investigational Site
La chapelle sur erdre, France, 44240
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Asnieres sur seine, France, 92600
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Carresse Cassaber, France, 64270
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fontenay sous bois, France, 94120
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lamarche sur saone, France, 21760
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Boulogne billancourt, France, 92100
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Neuville sur saone, France, 69250
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Gouy sous bellonne, France, 62112
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Divonne les bains, France, 01220
Status
Terminated/Withdrawn
Location
GSK Investigational Site
La motte servolex, France, 73290
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bois guillaume cedex, France, 76235
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Equeurdreville hainneville, France, 50120
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Champigny sur marne, France, 94500
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Moutiers tarentaise, France, 73600
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Les sables d olonne, France, 85100
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Villeneuve d ascq cedex, France, 59658
Status
Terminated/Withdrawn
Location
GSK Investigational Site
St remy de provence, France, 13210
Status
Terminated/Withdrawn
Location
GSK Investigational Site
St aubin sur scie, France, 76550
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Montigny les metz, France, 57950
Status
Terminated/Withdrawn
Location
GSK Investigational Site
St etienne de montluc, France, 44360
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ozoir la ferriere, France, 77330
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Cherbourg - octeville, France, 50130
Status
Terminated/Withdrawn
Location
GSK Investigational Site
St loup sur semouse, France, 70800
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ste foy la grande, France, 33220
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Camphin en carembault, France, 59133
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Vandoeuvre les nancy, France, 54500
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Le palais sur vienne, France, 87410
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Gonneville la mallet, France, 76280
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Villars les Dombes, France, 01330
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pierrefitte sur sauldre, France, 41300
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Illkirch graffenstaden, France, 67400
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chateauneuf les martigues, France, 13220
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fontaine les dijon, France, 21121
Status
Terminated/Withdrawn
Location
GSK Investigational Site
St jean de la ruelle, France, 45140
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Montoire sur le loir, France, 41800
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Merkwiller pechelbronn, France, 67250
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Gamarde les bains, France, 40380
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Villiers sur marne, France, 94350
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Le passage d' agen, France, 47520
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chanteloup les vignes, France, 78570
Status
Terminated/Withdrawn
Location
GSK Investigational Site
St cyr au mont d'or, France, 69450
Status
Terminated/Withdrawn
Location
GSK Investigational Site
St germain les arpajon, France, 91180
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Villeurbanne cedex, France, 69626
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rosieres en santerre, France, 80170
Status
Terminated/Withdrawn
Location
GSK Investigational Site
La garenne colombes, France, 92250
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Quevreville la poterie, France, 76520
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Beaulieu les loches, France, 37600
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chatenois les forges, France, 90700
Status
Terminated/Withdrawn
Location
GSK Investigational Site
La source orleans, France, 45100
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pont l abbe d arnoult, France, 17250
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Conde sur noireau, France, 14110
Status
Terminated/Withdrawn
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2012-06-04
Actual study completion date
2012-06-04
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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Access to clinical trial data by researchers
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