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Acceptability of Hepatitis B Vaccination in General Population

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01782794
Acronym
PopCorn
Enrollment
2413
Registered
2013-02-04
Start date
2009-05-31
Completion date
2012-06-30
Last updated
2013-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

Keywords

Vaccination, Acceptability, General population, Hepatitis B, Vaccine coverage

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.

Interventions

OTHERData collection

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

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Observational model
FAMILY_BASED
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
12 Months to 27 Months
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Proportion of infants receiving Hepatitis B vaccination.4 years

Secondary

MeasureTime frameDescription
Evaluation of the immunization coverage levels by other vaccines.4 yearsThe 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 YearsAcceptability 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026