Last updated: 11/07/2018 05:50:52
Acceptability of Hepatitis B vaccination in general populationPopCorn
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
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
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Proportion of infants receiving Hepatitis B vaccination.
Timeframe: 4 years
Secondary outcomes:
Evaluation of the immunization coverage levels by other vaccines.
Timeframe: 4 years
Acceptability of vaccinating against Hepatitis B.
Timeframe: 4 Years
Interventions:
Other: Data collection
Enrollment:
2413
Observational study model:
Family-Based
Primary completion date:
2012-19-06
Time perspective:
Cross-Sectional
Clinical publications:
Gaudelus J et al. (2016) 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. 64(1); 23-32.
Medical condition
Hepatitis B
Product
SB217744
Collaborators
Not applicable
Study date(s)
May 2009 to June 2012
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
12 - 27 months
Accepts healthy volunteers
Yes
- 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.
- Refusal to take part.
- Infants having lived in another country in their first two years of life.
Inclusion and exclusion criteria
Inclusion criteria:
- With a parent or legal representative agreeing to take part in the interview.
- Residing in metropolitan France.
Infants aged 12 to 15 months or 24 to 27 months inclusive at the time of the study.
Exclusion criteria:
- Infants having lived in another country in their first two years of life.
Refusal to take part.
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2012-19-06
Actual study completion date
2012-19-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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