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
Study complete
Study complete
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:
Enrollment:
474
Primary completion date:
2012-06-04
Observational study model:
Cohort
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
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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
Study complete
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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