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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014