Acceptability of Hepatitis B Vaccination in General Population
PopCorn
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
1 other identifier
observational
2,413
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2009
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 24, 2013
CompletedFirst Posted
Study publicly available on registry
February 4, 2013
CompletedFebruary 4, 2013
January 1, 2013
3.1 years
January 24, 2013
January 31, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of infants receiving Hepatitis B vaccination.
4 years
Secondary Outcomes (2)
Evaluation of the immunization coverage levels by other vaccines.
4 years
Acceptability of vaccinating against Hepatitis B.
4 Years
Study Arms (2)
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.
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.
Interventions
Poll and questionnaire-based methodology completed by face-to-face interviews, with possible additional follow-up offered to households.
Eligibility Criteria
The study population will consist of parents (with infants) agreeing to take part in a personal interview.
You may qualify if:
- 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.
You may not qualify if:
- Refusal to take part.
- Infants having lived in another country in their first two years of life.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Related Publications (1)
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.
PMID: 26748972DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- observational
- Observational Model
- FAMILY BASED
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2013
First Posted
February 4, 2013
Study Start
May 1, 2009
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
February 4, 2013
Record last verified: 2013-01