Acceptability of Hepatitis B Vaccination in General Population

GlaxoSmithKline2,413 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

2,413

Conditions

Hepatitis B

Interventions

Data collectionOTHER

Poll and questionnaire-based methodology completed by face-to-face interviews, with possible additional follow-up offered to households.

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 27 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Proportion of infants receiving Hepatitis B vaccination.

Time frame: 4 years

Secondary Outcomes

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).

Time frame: 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.

Time frame: 4 Years

Data from ClinicalTrials.gov

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