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Acceptability of Hepatitis B Vaccination in General Practitioners and Paediatricians (PRALINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01777074
Recruitment Status : Completed
First Posted : January 28, 2013
Last Update Posted : February 4, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Hepatitis B Other: Data collection

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.

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Study Type : Observational
Actual Enrollment : 474 participants
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
Study Start Date : November 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Generalist physicians Cohort Other: Data collection
Questionnaire, Vaccination book

Paediatricians Cohort Other: Data collection
Questionnaire, Vaccination book

Primary Outcome Measures :
  1. Change in the proportion of physicians with at least 50% of infants immunized against Hepatitis B. [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Type of physicians, based on the questionnaire regarding immunization practices and established at each measurement time point. [ Time Frame: 4 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01777074

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Sponsors and Collaborators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline Identifier: NCT01777074     History of Changes
Other Study ID Numbers: 113385
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: February 4, 2013
Last Verified: January 2013
Keywords provided by GlaxoSmithKline:
Hepatitis B
Additional relevant MeSH terms:
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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
Immunologic Factors
Physiological Effects of Drugs