Acceptability of Hepatitis B Vaccination in General Practitioners and Paediatricians (PRALINE)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Hepatitis B |
Other: Data collection |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | Measurement of the Changes in Acceptability of Hepatitis B Immunization Among General Practitioners and Open-care Paediatricians |
- Change in the proportion of physicians with at least 50% of infants immunized against Hepatitis B. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Type of physicians, based on the questionnaire regarding immunization practices and established at each measurement time point. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
| Enrollment: | 474 |
| Study Start Date: | November 2009 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Generalist physicians Cohort
Not Applicable
|
Other: Data collection
Questionnaire, Vaccination book
|
|
Paediatricians Cohort
Not Applicable
|
Other: Data collection
Questionnaire, Vaccination book
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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.
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.
Contacts and Locations
Show 402 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01777074 History of Changes |
| Other Study ID Numbers: | 113385 |
| Study First Received: | January 24, 2013 |
| Last Updated: | January 31, 2013 |
| Health Authority: | France: Haute Autorité de santé (HAS) |
Keywords provided by GlaxoSmithKline:
|
Vaccination Acceptability Hepatitis B |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections |
ClinicalTrials.gov processed this record on June 13, 2013