Hepatitis BPopCornNCT01782794
Acceptability of Hepatitis B Vaccination in General Population
An observational study of Hepatitis B, run by GlaxoSmithKline.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 27 monthsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Data collection
- Type of treatment
- Vaccines
- How many people
- 2,413 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 27 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population will consist of parents (with infants) agreeing to take part in a personal interview.
Who may be able to join
- 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.
Who cannot join
- Refusal to take part.
- Infants having lived in another country in their first two years of life.
About this study
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
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.
Read the 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.
- Conditions
- Hepatitis B
- Being tested
- Data collection
- Keywords
- Vaccination, Acceptability, General population, Hepatitis B, Vaccine coverage
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Poll and questionnaire-based methodology completed by face-to-face interviews, with possible additional follow-up offered to households.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Data collection | |
| 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. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of infants receiving Hepatitis B vaccination.
Measured: 4 years
Secondary outcomes (2)
Evaluation of the immunization coverage levels by other vaccines.
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).
Measured: 4 years
Acceptability of vaccinating against Hepatitis B.
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.
Measured: 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startMay 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 2,413 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782794
- Sponsor's protocol ID
- 113269
- Acronym
- PopCorn
- Status last verified
- Jan 2013
- First submitted
- 24 Jan 2013
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26748972
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01782794
- Acronym / sponsor ID
- PopCorn / 113269
- Conditions
- Hepatitis B
- Keywords
- Vaccination, Acceptability, General population, Hepatitis B, Vaccine coverage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,413 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 4 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Other: Data collectionChildren 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 | – | Other: Data collectionChildren 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. |
Who may qualify
- Ages
- 12 to 27 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population will consist of parents (with infants) agreeing to take part in a personal interview.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Refusal to take part.
- Infants having lived in another country in their first two years of life.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionPoll and questionnaire-based methodology completed by face-to-face interviews, with possible additional follow-up offered to households. | Other | Cohort A, Cohort B |
Primary outcome
Proportion of infants receiving Hepatitis B vaccination.
Time frame: 4 years
2 secondary outcomes
Evaluation of the immunization coverage levels by other vaccines.
Time frame: 4 years
Acceptability of vaccinating against Hepatitis B.
Time frame: 4 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
- Derived from this study: PubMed 26748972Gaudelus 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of infants receiving Hepatitis B vaccination. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01782794, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2013.