Clinical trial NCT01782794: Acceptability of Hepatitis B Vaccination in General Population
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Keywords: Vaccination
Acceptability
General population
Hepatitis B
Vaccine coverage
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-02-04
Enrollment: 2413
Sex: ALL
Minimum age (years): 12
Maximum age (years): 27
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of parents (with infants) agreeing to take part in a personal interview.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of infants receiving Hepatitis B vaccination.
timeFrame: 4 years
Secondary outcomes:
measure: Evaluation of the immunization coverage levels by other vaccines.
timeFrame: 4 years
measure: Acceptability of vaccinating against Hepatitis B.
timeFrame: 4 Years
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Gaudelus J, Vie le Sage F, Dufour V, Lert F, Texier N, Pouriel M, Tehard B, Breart G. Public health impact of Infanrix hexa (DTPa-HBV-IPV/Hib) reimbursement: A study programme in France. Part 1: Evolution of hepatitis B vaccine coverage rates in infants aged less than 27 months, in the general population - the PopCorn study. Rev Epidemiol Sante Publique. 2016 Feb;64(1):23-32. doi: 10.1016/j.respe.2015.11.007. Epub 2015 Dec 31.