Acceptability of Hepatitis B Vaccination in General Population

Hepatitis B Clinical Trial

— PopCorn  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01782794
• Other study ID #: 113269
• Status: Completed
• Phase: N/A
• First received: January 24, 2013
• Last updated: January 31, 2013
• Start date: May 2009
• Est. completion date: June 2012

Study information

• Verified date: January 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Haute Autorité de santé (HAS)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2413
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 27 Months

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of infants receiving Hepatitis B vaccination.		4 years	No
Secondary	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).	4 years	No
Secondary	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.	4 Years	No