Acceptability of Hepatitis B Vaccination in General Population (PopCorn)

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Hepatitis B

Treatments: Other: Data collection

Study type: Observational

Funder types: Industry

Identifiers

NCT01782794

113269

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,413 patients

Sex: All

Ages: 12 to 27 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

2,413 participants in 2 patient groups

Cohort A

Description:

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.

Treatment:

Other: Data collection

Cohort B

Description:

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.

Treatment:

Other: Data collection