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Acceptability of Hepatitis B Vaccination in General Population

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B

Intervention: Data collection (Other)

Phase: N/A

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline


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.

Clinical Details

Official title: 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

Study design: Observational Model: Family-Based, Time Perspective: Cross-Sectional

Primary outcome: Proportion of infants receiving Hepatitis B vaccination.

Secondary outcome:

Evaluation of the immunization coverage levels by other vaccines.

Acceptability of vaccinating against Hepatitis B.

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.


Minimum age: 12 Months. Maximum age: 27 Months. Gender(s): Both.


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.

Locations and Contacts

Additional Information

Starting date: May 2009
Last updated: January 31, 2013

Page last updated: August 20, 2015

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