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OpenTrials
Completed

NCT Number: NCT01777074

Acceptability of Hepatitis B Vaccination in General Practitioners and Paediatricians

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Agde, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Collection

Other

Questionnaire, Vaccination book

Primary outcomes

  1. Change in the proportion of physicians with at least 50% of infants immunized against Hepatitis B.

    Time frame: 4 years

Secondary outcomes

  1. Type of physicians, based on the questionnaire regarding immunization practices and established at each measurement time point.

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Measurement of the Changes in Acceptability of Hepatitis B Immunization Among General Practitioners and Open-care Paediatricians

Acronym: PRALINE

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 28, 2013
Registry last updated
Feb 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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