Clinical trial NCT01777074: Acceptability of Hepatitis B Vaccination in General Practitioners and Paediatricians
Official title: Measurement of the Changes in Acceptability of Hepatitis B Immunization Among General Practitioners and Open-care Paediatricians
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Keywords: Vaccination
Acceptability
Hepatitis B
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-01-28
Enrollment: 474
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility 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:

* Children on the eligibility register not complying with the investigator's immunization policy.
* Refusal of the patient.

Primary outcomes:
measure: Change in the proportion of physicians with at least 50% of infants immunized against Hepatitis B.
timeFrame: 4 years
Secondary outcomes:
measure: Type of physicians, based on the questionnaire regarding immunization practices and established at each measurement time point.
timeFrame: 4 years
Other outcomes:
Locations:
city: Agde cedex
country: France
facility: GSK Investigational Site
city: Agen cedex
country: France
facility: GSK Investigational Site
city: Agen
country: France
facility: GSK Investigational Site
city: Aire sur la lys
country: France
facility: GSK Investigational Site
city: Aizenay
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facility: GSK Investigational Site
city: Albi
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city: Ales
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facility: GSK Investigational Site
city: Alleins
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
city: St pierre d irube
country: France
facility: GSK Investigational Site
city: St pol sur mer
country: France
facility: GSK Investigational Site
city: St priest
country: France
facility: GSK Investigational Site
city: St remy de provence
country: France
facility: GSK Investigational Site
city: St tropez
country: France
facility: GSK Investigational Site
city: Ste foy la grande
country: France
facility: GSK Investigational Site
city: Ste maxime
country: France
facility: GSK Investigational Site
city: Strasbourg cedex
country: France
facility: GSK Investigational Site
city: Strasbourg
country: France
facility: GSK Investigational Site
city: Strasbourg
country: France
facility: GSK Investigational Site
city: Sucy en brie
country: France
facility: GSK Investigational Site
city: Suresnes
country: France
facility: GSK Investigational Site
city: Talence
country: France
facility: GSK Investigational Site
city: Tarascon
country: France
facility: GSK Investigational Site
city: Thiais
country: France
facility: GSK Investigational Site
city: Thonon les bains
country: France
facility: GSK Investigational Site
city: Thun st amand
country: France
facility: GSK Investigational Site
city: Toulon
country: France
facility: GSK Investigational Site
city: Toulon
country: France
facility: GSK Investigational Site
city: Toulouse
country: France
facility: GSK Investigational Site
city: Toul
country: France
facility: GSK Investigational Site
city: Tours
country: France
facility: GSK Investigational Site
city: Trie chateau
country: France
facility: GSK Investigational Site
city: Troyes
country: France
facility: GSK Investigational Site
city: Vabres l abbaye
country: France
facility: GSK Investigational Site
city: Val de vesle
country: France
facility: GSK Investigational Site
city: Valence
country: France
facility: GSK Investigational Site
city: Vallauris
country: France
facility: GSK Investigational Site
city: Vandoeuvre les nancy
country: France
facility: GSK Investigational Site
city: Vannes cedex
country: France
facility: GSK Investigational Site
city: Vannes
country: France
facility: GSK Investigational Site
city: Vaugneray
country: France
facility: GSK Investigational Site
city: Vaulx en velin
country: France
facility: GSK Investigational Site
city: Vaureal
country: France
facility: GSK Investigational Site
city: Vaux le penil
country: France
facility: GSK Investigational Site
city: Vendargues
country: France
facility: GSK Investigational Site
city: Vernouillet
country: France
facility: GSK Investigational Site
city: Versailles
country: France
facility: GSK Investigational Site
city: Vertou
country: France
facility: GSK Investigational Site
city: Villars les Dombes
country: France
facility: GSK Investigational Site
city: Villeblevin
country: France
facility: GSK Investigational Site
city: Villeneuve d ascq cedex
country: France
facility: GSK Investigational Site
city: Villeurbanne cedex
country: France
facility: GSK Investigational Site
city: Villiers sur marne
country: France
facility: GSK Investigational Site
city: Vincennes
country: France
facility: GSK Investigational Site
city: Viry chatillon
country: France
facility: GSK Investigational Site
city: Vitrolles
country: France
facility: GSK Investigational Site
city: Vitry sur Seine
country: France
facility: GSK Investigational Site
city: Voreppe
country: France
facility: GSK Investigational Site
city: Wattignies
country: France
facility: GSK Investigational Site
city: Yerres
country: France
facility: GSK Investigational Site
city: Zillisheim
country: France
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: