Acceptability of Hepatitis B Vaccination in General Population

NCT ID: NCT01782794

Last Updated: 2013-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2413 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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Hepatitis B

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cohort A

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.

Data collection

Intervention Type OTHER

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

Cohort B

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.

Data collection

Intervention Type OTHER

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

Interventions

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Data collection

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

12 Months

Maximum Eligible Age

27 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

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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.

Reference Type DERIVED
PMID: 26748972 (View on PubMed)

Other Identifiers

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113269

Identifier Type: -

Identifier Source: org_study_id

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