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
Study complete
Study complete
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:
Enrollment:
2413
Primary completion date:
2012-19-06
Observational study model:
Family-Based
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)
This study does not involve prospective enrollment of participants.
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
Study complete
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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