Acceptability of Hepatitis B Vaccination in General Population

Completed

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

• Registration Number: NCT01782794
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The present study is conducted in order to assess the acceptability of Hepatitis B vaccination in French general population before and after reimbursement of the paediatric vaccine InfanrixHexa. Four measurements are planned, first before reimbursement and the others at year 1, 2 and 3 after reimbursement.

Detailed Description

The present study aims to evaluate the changes in Hepatitis B immunization coverage and the acceptability thereof among parents, in the general population. This is a national, prospective, epidemiological study, comprising four measurement time-points over a three-year period, (T1 in 2009, T2 in 2010, T3 in 2011, and T4 in 2012) in order to cover the period prior to the introduction of InfanrixHexa® reimbursement, the transition period, and the period following reimbursement of the vaccine. The periods between each data collection time-point will be identical, lasting a year. Two age groups will be investigated at each data collection time-point: 12-15 months and 24-27 months, thus providing measurements before/after reimbursement.

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-01
• Study First Submitted: 2013-01-24
• Study First Submitted QC: 2013-01-31
• Last Update Submitted: 2013-01-31
• Study First Posted: 2013-02-04
• Last Update Posted: 2013-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2413

Inclusion Criteria

• Infants aged 12 to 15 months or 24 to 27 months inclusive at the time of the study.
• With a parent or legal representative agreeing to take part in the interview.
• Residing in metropolitan France.

Exclusion Criteria

• Refusal to take part.
• Infants having lived in another country in their first two years of life.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort B	Data collection	Children aged 24-27 months at the time of the study. Measurements of Hepatitis B vaccination cover prior to InfanrixHexa reimbursement was obtained from this cohort.
Cohort A	Data collection	Children aged 12-15 months at the time of the study. Measurements of Hepatitis B vaccination cover prior to InfanrixHexa reimbursement was obtained from this cohort.

Primary Outcome Measures

Name	Time	Method
Proportion of infants receiving Hepatitis B vaccination.	4 years

Secondary Outcome Measures

Name	Time	Method
Evaluation of the immunization coverage levels by other vaccines.	4 years	The vaccination coverage by other vaccines will be described for each time point (i.e. at the initial time point, and at the years 1, 2 and 3 time points).
Acceptability of vaccinating against Hepatitis B.	4 Years	Acceptability of vaccinating against hepatitis B will be evaluated via assessment of the variation of this acceptability amongst parents categorised as "accepting", using their responses to a semi-qualitative questionnaire about vaccination.