Acceptability of Hepatitis B Vaccination in General Practitioners and Paediatricians

Completed

• Conditions: Hepatitis B
• Interventions: Other: Data collection

• Registration Number: NCT01777074
• Lead Sponsor: GlaxoSmithKline

Brief 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.

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.

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2013-01
• Study First Submitted: 2013-01-24
• Study First Submitted QC: 2013-01-24
• Study First Posted: 2013-01-28
• Last Update Submitted: 2013-01-31
• Last Update Posted: 2013-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 474

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Generalist physicians Cohort	Data collection	-
Paediatricians Cohort	Data collection	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇫🇷 Zillisheim, France