PRALINE - Measurement of the changes in acceptability of hepatitis B immunization among general practitioners and open-care paediatricians
Head :
Leclerc-Zwirn Christel, Laboratoire GSK
Last update : 09/07/2020 | Version : 1 | ID : 160
| General | |
| Identification | |
| Detailed name | Measurement of the changes in acceptability of hepatitis B immunization among general practitioners and open-care paediatricians |
| Sign or acronym | PRALINE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
| General Aspects | |
| Medical area |
Immunology Infectious diseases |
| Pathology (details) | acceptability of the Hepatitis B vaccination, measuring vaccinal practices |
| Keywords | vaccine, vaccination practice |
| Scientific investigator(s) (Contact) | |
| Name of the director | Leclerc-Zwirn |
| Surname | Christel |
| Phone | +33 (0)1 39 17 86 96 |
| christel.c.leclerc-zwirn@gsk.com | |
| Unit | Laboratoire GSK |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | GSK laboratory |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Laboratoire GSK |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Not-repeated cross-sectional studies (except case control studies) |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals An administrative base or a register |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | For each measurement time, a national representative sample of French general practitioners (liberal) and pediatricians (liberal and mixed exercise) will be formed through simple random sampling within a sampling frame of the CEGEDIM type |
| Database objective | |
| Main objective | Measure, in general and pediatric practices, the change in the acceptability of the vaccination against Hepatitis B for children aged 27 months and younger before the reimbursement of InfanrixHexa®, then during the three following years in France |
| Inclusion criteria |
• Children from the eligibility registry subjected to the vaccinal policy by the investigator. This criterion will be evaluated using the declarations of the doctors, via 2 questions:
1. ""Have you followed the child since birth? If yes: date of the 1st consultation of the child. If no: did you follow the child the first 6 months? » 2. ""Are you the doctor in charge of vaccinating this child since birth? » |
| Population type | |
| Age |
Newborns (birth to 28 days) Infant (28 days to 2 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
General population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2009 |
| Date of last collection (YYYY or MM/YYYY) | 2012 |
| Size of the database | |
| Size of the database (number of individuals) |
[10 000-20 000[ individuals |
| Details of the number of individuals | 928 practitioners 13920 infants |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures |
| Declarative data (detail) |
Paper self-questionnaire Phone interview |
| Presence of a biobank |
No |
| Health parameters studied |
Others |
| Other (detail) | Vaccination practice |
| Procedures | |
| Data collection method | The investigating doctor will complete the two eligibility registries. If the vaccination booklet is not available on the day of consultation, the doctor will ask the child's parent to provide the vaccination booklet in the next few days and will then finish filling in the vaccination data in the registry. If the vaccination booklet is not available on the day of consultation, the key information on the vaccination of the child will be completed using the patient's dossier of the doctor, noting the absence of the vaccination booklet.The acceptability questionnaire (paper CRF) will be administered to participating doctors by a clinical research associate, by telephone, during the installation of the center.The data will be collected in the eligibility registry for all of the patients aged 12 to 15 months and 24 to 27 months spontaneously consulting the investigator over the duration of the study |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Abstract and publications |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
