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Acceptability of Hepatitis B Vaccination in General Population (PopCorn)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01782794
First received: January 24, 2013
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Hepatitis B
 Other: Data collection

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Proportion of infants receiving Hepatitis B vaccination. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of the immunization coverage levels by other vaccines. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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).

  • Acceptability of vaccinating against Hepatitis B. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]
    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.


Enrollment: 2413
Study Start Date: May 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
 Other: Data collection
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.
 Other: Data collection
Poll and questionnaire-based methodology completed by face-to-face interviews, with possible additional follow-up offered to households.

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

Ages Eligible for Study:   12 Months to 27 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The study population will consist of parents (with infants) agreeing to take part in a personal interview.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782794

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01782794     History of Changes
Other Study ID Numbers: 113269
Study First Received: January 24, 2013
Last Updated: January 31, 2013
Health Authority: France: Haute Autorité de santé (HAS)

Keywords provided by GlaxoSmithKline:
Vaccination
Acceptability
General population
Hepatitis B
Vaccine coverage

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on May 23, 2013