Acceptability of Hepatitis B Vaccination in General Population

Study Overview
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Brief Summary
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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
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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.

Official Title
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Measurement of the Changes in Hepatitis B Immunization Coverage in Infants, and the Acceptability Thereof, Before Reimbursement, Then During the Three Years After Reimbursement of InfanrixHexa® in France, Among the General Population

Conditions
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Hepatitis B

Intervention / Treatment
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* Other: Data collection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 27 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A<br>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. | Other: Data collection<br>* Poll and questionnaire-based methodology completed by face-to-face interviews, with possible additional follow-up offered to households.<br>|
| Cohort B<br>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. | Other: Data collection<br>* Poll and questionnaire-based methodology completed by face-to-face interviews, with possible additional follow-up offered to households.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of infants receiving Hepatitis B vaccination. |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the immunization coverage levels by other vaccines. | 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). | 4 years | 
| Acceptability of vaccinating against Hepatitis B. | 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. | 4 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccination, Acceptability, General population, Hepatitis B, Vaccine coverage